Prosecution Insights
Last updated: May 04, 2026
Application No. 18/006,883

NOVEL T CELLS AND THE USES THEREOF

Non-Final OA §101§102§103
Filed
Jan 26, 2023
Priority
Jul 27, 2020 — EU 20305861.5 +2 more
Examiner
SVEIVEN, MICHAEL CAMERON
Art Unit
1678
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Assistance Publique - Hôpitaux de Paris
OA Round
1 (Non-Final)
31%
Grant Probability
At Risk
1-2
OA Rounds
4m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants only 31% of cases
31%
Career Allowance Rate
5 granted / 16 resolved
-28.7% vs TC avg
Strong +44% interview lift
Without
With
+43.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
34 currently pending
Career history
50
Total Applications
across all art units

Statute-Specific Performance

§101
9.6%
-30.4% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
19.9%
-20.1% vs TC avg
§112
23.8%
-16.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 16 resolved cases

Office Action

§101 §102 §103
CTNF 18/006,883 CTNF 99819 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of Foreign Application EUROPEAN PATENT OFFICE (EPO) 20305861.5 filed 07/27/2020. Based on the filing receipt, the effective filing date of this application is July 27, 2020, which is the filing date of Foreign Application EUROPEAN PATENT OFFICE (EPO) 20305861.5 from which the benefit of priority is claimed. Information Disclosure Statements The information disclosure statement filed 01/26/2023 has been considered by the examiner. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I , claims 20-32 , in the reply filed on 02/23/2026 is acknowledged. 08-06 Claims 33-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2026. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-19 are cancelled. Claims 20-38 are pending. Claims 20-32 are examined herein. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 20-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and laws of nature/natural phenomena without significantly more. Under the MPEP, in determining what concept the claim is “directed to,” we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas ( i.e. , mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)). Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice , 573 U.S. at 221 (quoting Mayo , 566 U.S. at 82). In so doing, we thus consider whether the claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION Step 2A, Prong 1 Natural Laws: The claims recite, “A method for evaluating the risk of rejection of a transplant in a transplant subject, comprising determining, in a biological sample of the transplant subject, the level of CD3+CD4+CD57+ILT2+ T cells, said level being indicative of the risk of transplant rejection” (claim 27), “an increase in the level of CD3+CD4+CD57+ILT2+ T cells, in the subject after the transplant, is indicative of a risk of transplant rejection” (claim 29), and “(i) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 2 and 6 weeks post-transplant; and (ii) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 11 and 13 months post-transplant; an increase between the two levels of (i) and (ii) being indicative of a risk of transplant rejection” (claim 30). The natural relationships to which the claims are directed (i.e., the relationship between the level of CD3+CD4+CD57+ILT2+ T cells and a specific health condition/state) are laws of nature. Similar concepts have been held by the courts to constitute law of nature/natural phenomena, as in the identification of a correlation between the presence of biomarkers in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics , LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). In Mayo, the Supreme Court found that a claim was directed to a natural law, where the claim required administering a drug and determining the levels of a metabolite following administration, where the level of metabolite was indicative of a need to increase or decrease the dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs., Inc ., 566 U.S. 66, 74 (2012). The instant claims are similar to those in Mayo as they involve a "relation itself [which] exists in principle apart from any human action" (id. at 77), namely the relationship between the naturally occurring levels of biomarkers (i.e., the level of CD3+CD4+CD57+ILT2+ T cells) in a sample and risk of transplant rejection. Furthermore, biomarkers by definition indicate a relationship between biological characteristics in subjects to specific health conditions/states. The relationship between the biomarkers and the risk of transplant rejection is a judicial exception as it exists in principle apart from any human action; the relationship itself therefore cannot form the basis for eligibility. Further, the relationship between any biological marker and the relevant health condition or biological process is a judicial exception as it exists in principle apart from any human action; the relationship itself therefore cannot form the basis for eligibility Abstract Ideas: Also, the claims recite, “determining in vitro the presence or level of CD3+CD4+CD57+ILT2+ T cells” (claim 20), “determining, in a biological sample of the transplant subject, the level of CD3+CD4+CD57+ILT2+ T cells” (claim 27), and “(i) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 2 and 6 weeks post-transplant; and (ii) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 11 and 13 months post-transplant” (claim 30), and “in step (i) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 1 month post-transplant; and in step (ii) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 12 months post-transplant” (claim 31). Furthermore, the claims recite, “evaluating the risk of rejection of a transplant” (claim 27). The claimed steps of determining the presence or the level of CD3+CD4+CD57+ILT2+ T cells and evaluating the risk of rejection of a transplant may be categorized as abstract ideas, namely mental processes/ concepts performed in the human mind. The claims, under their broadest reasonable interpretation, cover performance of determining levels and evaluating risk solely within the human mind, or by a human using pen and paper. Step 2A, Prong 2 The above-discussed steps of “determining” the levels of biomarkers then “evaluating the risk” are insufficient to integrate the judicial exception into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application. In this case, determining levels of CD3+CD4+CD57+ILT2+ T cells and evaluating risk, represent judicial exceptions and not a practical application thereof. Furthermore, the limitations of “determining the presence or level of said cells in a sample from the subject at two time intervals, or more” (claim 21), “wherein the subject is transplanted or is a candidate for transplantation” (claim 22), “wherein the subject has a cancer” (claim 23), “wherein the subject has an autoimmune or infectious disease” (claim 24), “wherein the sample is a sample of biological fluid or tissue, said biological fluid being a sample of blood, plasma, serum, urine, or saliva” (claim 25), “wherein the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample is determined by flow cytometry, radioassay, enzymatic assay, immunoassay or radioimmunoassay” (claim 26), “wherein the transplant is a lung transplant” (claim 28), taking biological samples “between 2 and 6 weeks post-transplant” (claim 30), “between 11 and 13 months post-transplant” (claim 30), “approximately 1 month post-transplant” (claim 31), and “approximately 12 months post-transplant” (claim 31) are insufficient to integrate the judicial exception into a practical application because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams , 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc . (Fed. Cir. 2015). ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT" The additional elements of the claims, including “wherein the subject’s post-transplant treatment is adapted to the risk of rejection of a transplant” (claim 32), therein, do not add significantly more to the judicial exceptions. Adapting treatment to risk is routine and conventional in the art and is recited at a high level of generality and is not limited by any specific treatments. The step is routine and conventional, which is not contributing an inventive concept. For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exceptions. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 20-21, 23, and 25 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Zhang (“Dynamics of peripheral T cell clones during PD-1 blockade in non-small cell lung cancer”, published 2020-06-26) . With respect to claim 20, Zhang teaches a method of monitoring a subject, comprising determining in vitro the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample from the subject (see, e.g., p. 2601, under “Single-cell preparation and sequencing”, para. 1-2, and p. 2599, under “Abstract”: “We identified individual peripheral T cell clones based on the full-length T cell receptor (TCR) sequences and monitored their dynamics during immunotherapy”). It is understood that single-cell sequencing will inherently determine the presence of all T cell phenotypes, including CD3+CD4+CD57+ILT2+ T cells. With respect to claim 21, Zhang teaches a method comprising determining the presence or level of said cells in a sample from the subject at two time intervals, or more (see, e.g., p. 2603, para. 3: “To monitor the T cell response to the immunotherapy, we collected blood samples from each responder before treatment (pre-treatment) and every 6 weeks […] we obtained Smart-seq2 [23] scRNA-seq data of 3,110 individual CD8+ and CD4+ T cells”). With respect to claim 23, Zhang teaches a method wherein the subject has a cancer (see, e.g., p. 2602, under “Results”, under “Patient enrollment and single T cell sequencing”: “Four patients (Pt1, Pt2, Pt3 and Pt4) with stage IV NSCLC were enrolled in this study and received PD-1 blockade nivolumab as the second-line treatment (Table 1). Pt1, Pt2 and Pt4 were diagnosed with adenocarcinoma, and Pt3 with squamous cell carcinoma”). With respect to claim 25, Zhang teaches wherein the sample is a sample of biological fluid or tissue, said biological fluid being a sample of blood (see, e.g., p. 2603, para. 3: “To monitor the T cell response to the immunotherapy, we collected blood samples from each responder before treatment (pre-treatment) and every 6 weeks”) . 07-15 AIA Claim s 20, 22, and 27-28 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Snyder (“Generation and persistence of human tissue-resident memory T cells in lung transplantation”, published 2019-03-08) . With respect to claim 20, Snyder teaches a method of monitoring a subject, comprising determining in vitro the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample from the subject (see, e.g., p. 12, under “Single cell transcriptome profiling by RNA sequencing”). It is understood that single-cell sequencing of T cells will inherently determine the presence of all T cell phenotypes, including CD3+CD4+CD57+ILT2+ T cells. With respect to claims 22 and 28, Snyder teaches a method wherein the subject is transplanted or is a candidate for transplantation, specifically a lung transplant (see, e.g., p. 10, under “MATERIAL AND METHODS”, under “Study Design and subject recruitment”: “BAL and blood samples were obtained from the remaining twenty lung transplant recipients included in this study”). With respect to claim 27, Snyder teaches a method for evaluating the risk of rejection of a transplant in a transplant subject, comprising determining, in a biological sample of the transplant subject, the level of CD3+CD4+CD57+ILT2+ T cells, said level being indicative of the risk of transplant rejection (see, e.g., p. 1, under “Abstract”: “Transplant recipients exhibiting higher frequencies of persisting donor TRM [(tissue resident memory T cells)] experienced fewer adverse clinical events such as primary graft dysfunction and acute cellular rejection compared to recipients with low donor TRM persistence, suggesting that monitoring TRM dynamics could be clinically informative”) . 07-15 AIA Claim s 20 and 24 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Wen (“Immune cell profiling of COVID-19 patients in the recovery stage by single-cell sequencing”, published 2020-05-04) . With respect to claim 20, Wen teaches a method of monitoring a subject, comprising determining in vitro the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample from the subject (see, e.g., p. 14, under “Single-cell collection and scRNA-seq”). It is understood that single-cell sequencing of peripheral blood mononuclear cells will inherently determine the presence of all T cell phenotypes, including CD3+CD4+CD57+ILT2+ T cells. With respect to claim 24, Wen teaches a method wherein the subject is an infection disease (see, e.g., p. 14, under “Materials and methods”, under “Patients”) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-22-aia AIA Claim s 22, 27, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (cited above) , as applied to claim s 20-21, 23, and 25 above, and further in view of Dorr (“Differentially Expressed Gene Transcripts Using RNA Sequencing from the Blood of Immunosuppressed Kidney Allograft Recipient”, published 2015-05-06) . Zhang teaches as set forth above, but fails to teach the subject his transplanted or is a candidate for transplantation, as in claim 22. Zhang fails to teach a method for evaluating the risk of rejection of a transplant in a transplant subject, as in claim 27. Zhang fails to teach a method comprising:(i) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 2 and 6 weeks post-transplant; and (ii) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 11 and 13 months post-transplant; an increase between the two levels of (i) and (ii) being indicative of a risk of transplant rejection, as in claim 30. Zhang fails to teach a method, wherein in step (i) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 1 month post-transplant; and in step (ii) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 12 months post-transplant, as in claim 31. Zhang fails to teach a method, wherein the subject's post-transplant treatment is adapted to the risk of rejection of a transplant, as in claim 32. However, Dorr teaches determining the level of CD3+CD4+CD57+ILT2+ cells in a sample from a transplant subject taken 1 week, 3 months, and 6 months post-transplant and adapting post-transplant treatment, as in claims 22, 27, and 32 (see, e.g., p. 1, under “Abstract”: “Blood was obtained pre-transplant (baseline), week 1, months 3 and 6 post-transplant. PBMCs were isolated, RNA extracted and gene expression measured using RNAseq”, and p. 2, para. 1 “selecting and personalizing immune suppressant drugs”). Zhang and Dorr are analogous to the field of the claimed invention because they are both in the field of transcriptomics. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the longitudinal measurements of biological samples from transplant subjects of Dorr into the methods of Zhang . An artisan would have been motivated to do so because Dorr discloses, “Further investigations to determine the specific lymphocyte(s) responsible for differential gene expression may be important in selecting and personalizing immune suppressant drugs and may lead to targeted therapies” (see, p. 2, para. 1). An artisan would understand that using the methods of Zhang would allow the determination of specific T-cells responsible for differential gene expression, allowing for the selection of personalized immune suppressant drugs and targeted therapies. An artisan would have had a reasonable expectation of success based on the given disclosures. With regards to claims 30 and 31, while Dorr discloses, “One previous study did investigate, longitudinally (years 1, 2, 3, and 4 post-transplant) RNA expression by microarray in biopsy and blood” and “we only have non-rejecting kidney recipients in our study up to 7 months post-transplant, and it is possible some of the patients had AR or CGD at a later time point when their immunosuppression is lowered” (see, p. 9, para. 3, and p. 10, para. 3), Zhang and Dorr do not explicitly disclose taking blood samples at 1 month and 12 months post-transplantation. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed method was anything other than routine, that the properties of the method from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Zhang and Dorr . 07-22-aia AIA Claim s 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder (cited above) , as applied to claim s 20, 22, and 27-28 above, and further in view of Dorr (“Differentially Expressed Gene Transcripts Using RNA Sequencing from the Blood of Immunosuppressed Kidney Allograft Recipient”, published 2015-05-06) . Snyder fails to teach a method comprising:(i) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 2 and 6 weeks post-transplant; and (ii) determining the level of CD3+CD4+CD57+ILT2+ T cells in a biological sample of the transplant subject, taken between 11 and 13 months post-transplant; an increase between the two levels of (i) and (ii) being indicative of a risk of transplant rejection, as in claim 30. Snyder fails to teach a method, wherein in step (i) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 1 month post-transplant; and in step (ii) the level of CD3+CD4+CD57+ILT2+ T cells is determined in a biological sample of the transplant subject taken approximately 12 months post-transplant, as in claim 31. Snyder fails to teach a method, wherein the subject's post-transplant treatment is adapted to the risk of rejection of a transplant, as in claim 32. However, Dorr teaches determining the level of CD3+CD4+CD57+ILT2+ cells in a sample from a transplant subject taken 1 week, 3 months, and 6 months post-transplant and adapting post-transplant treatment, as in claim 32 (see, e.g., p. 1, under “Abstract”: “Blood was obtained pre-transplant (baseline), week 1, months 3 and 6 post-transplant. PBMCs were isolated, RNA extracted and gene expression measured using RNAseq”, and p. 2, para. 1 “selecting and personalizing immune suppressant drugs”). Snyder and Dorr are analogous to the field of the claimed invention because they are both in the field of transcriptomics. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the longitudinal measurements of biological samples from transplant subjects of Dorr into the methods of Snyder . An artisan would have been motivated to do so because Dorr discloses, “Further investigations to determine the specific lymphocyte(s) responsible for differential gene expression may be important in selecting and personalizing immune suppressant drugs and may lead to targeted therapies” (see, p. 2, para. 1). An artisan would understand that using the methods of Snyder would allow the determination of specific T-cells responsible for differential gene expression, allowing for the selection of personalized immune suppressant drugs and targeted therapies. An artisan would have had a reasonable expectation of success based on the given disclosures. With regards to claims 30 and 31, while Dorr discloses, “One previous study did investigate, longitudinally (years 1, 2, 3, and 4 post-transplant) RNA expression by microarray in biopsy and blood” and “we only have non-rejecting kidney recipients in our study up to 7 months post-transplant, and it is possible some of the patients had AR or CGD at a later time point when their immunosuppression is lowered” (see, p. 9, para. 3, and p. 10, para. 3), Snyder and Dorr do not explicitly disclose taking blood samples at 1 month and 12 months post-transplantation. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed method was anything other than routine, that the properties of the method from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Snyder and Dorr . Conclusion Claims 26 and 29 are free of the prior art. However, claims 26 and 29 are rejected on the grounds of 35 U.S.C. 101. The closest prior art to claims 26 and 29 is Zhang (cited above). Zhang teaches a method of monitoring a subject, comprising determining in vitro the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample from the subject (see, e.g., p. 2601, under “Single-cell preparation and sequencing”, para. 1-2, and p. 2599, under “Abstract”: “We identified individual peripheral T cell clones based on the full-length T cell receptor (TCR) sequences and monitored their dynamics during immunotherapy”). It is understood that single-cell sequencing will inherently determine the presence of all T cell phenotypes, including CD3+CD4+CD57+ILT2+ T cells. However, Zhang fails to teach the presence or level of CD3+CD4+CD57+ILT2+ T cells in a sample is determined by flow cytometry, radioassay, enzymatic assay, immunoassay or radioimmunoassay, as in claim 26. Zhang fails to teach an increase in the level of CD3+CD4+CD57+ILT2+ T cells is indicative of a risk of transplant rejection, as in claim 29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C SVEIVEN whose telephone number is (703)756-4653. The examiner can normally be reached Monday to Friday - 8AM to 5PM PST. 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, Gregory Emch can be reached at (571) 272-8149. 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. /MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678 /GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678 Application/Control Number: 18/006,883 Page 2 Art Unit: 1678 Application/Control Number: 18/006,883 Page 3 Art Unit: 1678 Application/Control Number: 18/006,883 Page 4 Art Unit: 1678 Application/Control Number: 18/006,883 Page 5 Art Unit: 1678 Application/Control Number: 18/006,883 Page 6 Art Unit: 1678 Application/Control Number: 18/006,883 Page 7 Art Unit: 1678 Application/Control Number: 18/006,883 Page 8 Art Unit: 1678 Application/Control Number: 18/006,883 Page 9 Art Unit: 1678 Application/Control Number: 18/006,883 Page 10 Art Unit: 1678 Application/Control Number: 18/006,883 Page 11 Art Unit: 1678 Application/Control Number: 18/006,883 Page 12 Art Unit: 1678 Application/Control Number: 18/006,883 Page 13 Art Unit: 1678 Application/Control Number: 18/006,883 Page 14 Art Unit: 1678 Application/Control Number: 18/006,883 Page 15 Art Unit: 1678 Application/Control Number: 18/006,883 Page 16 Art Unit: 1678 Application/Control Number: 18/006,883 Page 17 Art Unit: 1678 Application/Control Number: 18/006,883 Page 18 Art Unit: 1678
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Prosecution Timeline

Jan 26, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
31%
Grant Probability
75%
With Interview (+43.6%)
3y 7m (~4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 16 resolved cases by this examiner. Grant probability derived from career allowance rate.

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