Prosecution Insights
Last updated: August 14, 2026
Application No. 19/199,682

Methods and Systems for Evaluation of Lupus Based on Ancestry-Associated Molecular Pathways

Final Rejection §101§102
Filed
May 06, 2025
Priority
Nov 10, 2022 — provisional 63/424,420 +1 more
Examiner
PAULSON, SHEETAL R.
Art Unit
3615
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Ampel Biosolutions LLC
OA Round
2 (Final)
39%
Grant Probability
At Risk
3-4
OA Rounds
3y 1m
Est. Remaining
55%
With Interview

Examiner Intelligence

Grants only 39% of cases
39%
Career Allowance Rate
261 granted / 666 resolved
-12.8% vs TC avg
Strong +16% interview lift
Without
With
+16.2%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
35 currently pending
Career history
696
Total Applications
across all art units

Statute-Specific Performance

§101
32.5%
-7.5% vs TC avg
§103
29.4%
-10.6% vs TC avg
§102
22.6%
-17.4% vs TC avg
§112
12.2%
-27.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 666 resolved cases

Office Action

§101 §102
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 . Prosecution History Summary Claims 4, 6-9, 11-13, and 16-18 are cancelled. Claims 21-33 are new. Claims 1-3, 10, 15, and 19-20 are amended. Claims 1-3, 5, 10, 14-15, and 19-33 are pending. 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, 5, 10, 14-15, and 19-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Subject Matter Eligibility Criteria – Step 1: The claims recite subject matter within a statutory category as a process (claims 1-3, 5, 10, 14-15, and 19-33). Accordingly, claims 1-3, 5, 10, 14-15, and 19-33 are all within at least one of the four statutory categories. Subject Matter Eligibility Criteria – Step 2A – Prong One: Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a). Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites: A method for treating lupus in a subject, the method comprising: a) analyzing a data set comprising or derived from gene expression measurements of a plurality of genes selected from a gene set to determine whether expression of genes in the gene set is enriched in a biological sample obtained or derived from the subject, wherein the gene set is selected from: (i) a first gene set comprising COX17, COX6A2, COX6B1, NDUFA5, NDUFA9, NDUFAB1, NDUFAF2, UQCR10, UQCRQ, and ATP5MG; (ii) a second gene set comprising ClQA, ClQB, ClQC, C2, C3, C4BPA,C4BPB, C5, C7, C6, C8a, C9, and CFP; (iii) a third gene set comprising COX6B1, COX17, NDUFA5, COX6A2,NDUFA9, NDUFAB1, NDUFAF2, UQCR10, and UQCRQ; (iv) a fourth gene set comprising ACO2, CS, DLAT, DLD, DLST, FH,GLUD1, IDH1, IDH2, IDH3A, IDH3B, IDH3G, MDH2, MPC1, MPC2,OGDH, OGDHL, PDHA1, PDHA2, PDHB, PDHX, PDK1, PDK2, PDK3,PDK4, PDP1, PDP2, PDPR, SDHA, SDHAF1, SDHAF2, SDHAF3,SDHAF4, SDHB, SDHC, SDHD, SUCLA2, SUCLG1, SUCLG2, and SUGCT; (v) a fifth gene set comprising AKR1A, ALDH1A1, ALDH2, ALDOB, ENOl, FBP1, G6PD, GALE, GAPDH, GOT1, HKDC1, LDHB, PCK1,PFKFB2, PFKP, PGM1, PKLR, RGN, SLC2A1, SLC2A5, and SLC37A4;(vi) a sixth gene set comprising ABCD1, ABCD2, ABCD3, ACAA2,ACACB, ACAD11, ACADL, ACADM, ACADS, ACADVL, ACAT1,ACAT2, ACOX1, ACOX2, ACOX3, ACOXL, ACSBG2, ACSL5, ADIPOQ, AKT2, AUH, BDH2, CPT1A, CPT2, CROT, DECR1, ECHDC1, ECHDC2,ECHS1, ECIl, ECI2, EHHADH, ETFA, ETFB, ETFDH, FABP1, GCDH,HADH, HADHA, HADHB, HIBCH, HSD17B4, IRS1, IRS2, IVD, LEP, PEX2, PEX5, PEX7, SESN2, SLC25A17, SLC27A2, and TWIST1; and (vii) a seventh gene set comprising FOS, GPX1, GPX3, DUSP1, GPX4,PRDX1, PRDX3, PRDX4, PRDX5, and S100A9; b) detecting a presence of lupus in the subject based on enrichment of the expression of genes in the gene set; and (c) administering to the subject a pharmaceutical agent capable of treating the lupus, wherein the pharmaceutical agent comprises baricitinib, carfilzomib,curcumol, decernotinib, delgocitinib, ruxolitinib, solicitinib, tofacitinib, upadacitinib, bortezomib, densosumab, filgotinib, idelalisib, KZR-616,peficitinib, sirolimus, everolimus, temsirolimus, adalimumab, AMG-811, BMS- 986165, certolizumab, dacomitinib, etanercept, iguratimod, infliximab,tabalumab, trofinetide, coenzyme Q10 (ubiquinoine) mipsagargin, resveratrol, N- acetyl L-cysteine, SKQ1, ubiquinone, mitoVitE, mitoTEMPO, vitamin E,vitamin C, ALT-2074, ebselen, GC4419, cyclosporin, metformin, phenformin,BAY84-2243, CAI, ME344, fenofibrate, lonidamine, arsenic trioxide,atovaquone, hydrocortisone, alpha-TOS, or thapsigargin. Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because analyzing data to diagnose lupus can all be performed in the human mind. Accordingly, the claim recites at least one abstract idea. Subject Matter Eligibility Criteria – Step 2A – Prong Two: Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(1(A). In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”): A method for treating lupus in a subject, the method comprising: a) analyzing a data set comprising or derived from gene expression measurements of a plurality of genes selected from a gene set to determine whether expression of genes in the gene set is enriched in a biological sample obtained or derived from the subject, wherein the gene set is selected from: (i) a first gene set comprising COX17, COX6A2, COX6B1, NDUFA5, NDUFA9, NDUFAB1, NDUFAF2, UQCR10, UQCRQ, and ATP5MG; (ii) a second gene set comprising ClQA, ClQB, ClQC, C2, C3, C4BPA,C4BPB, C5, C7, C6, C8a, C9, and CFP; (iii) a third gene set comprising COX6B1, COX17, NDUFA5, COX6A2,NDUFA9, NDUFAB1, NDUFAF2, UQCR10, and UQCRQ; (iv) a fourth gene set comprising ACO2, CS, DLAT, DLD, DLST, FH,GLUD1, IDH1, IDH2, IDH3A, IDH3B, IDH3G, MDH2, MPC1, MPC2,OGDH, OGDHL, PDHA1, PDHA2, PDHB, PDHX, PDK1, PDK2, PDK3,PDK4, PDP1, PDP2, PDPR, SDHA, SDHAF1, SDHAF2, SDHAF3,SDHAF4, SDHB, SDHC, SDHD, SUCLA2, SUCLG1, SUCLG2, and SUGCT; (v) a fifth gene set comprising AKR1A, ALDH1A1, ALDH2, ALDOB, ENOl, FBP1, G6PD, GALE, GAPDH, GOT1, HKDC1, LDHB, PCK1,PFKFB2, PFKP, PGM1, PKLR, RGN, SLC2A1, SLC2A5, and SLC37A4;(vi) a sixth gene set comprising ABCD1, ABCD2, ABCD3, ACAA2,ACACB, ACAD11, ACADL, ACADM, ACADS, ACADVL, ACAT1,ACAT2, ACOX1, ACOX2, ACOX3, ACOXL, ACSBG2, ACSL5, ADIPOQ, AKT2, AUH, BDH2, CPT1A, CPT2, CROT, DECR1, ECHDC1, ECHDC2,ECHS1, ECIl, ECI2, EHHADH, ETFA, ETFB, ETFDH, FABP1, GCDH,HADH, HADHA, HADHB, HIBCH, HSD17B4, IRS1, IRS2, IVD, LEP, PEX2, PEX5, PEX7, SESN2, SLC25A17, SLC27A2, and TWIST1; and (vii) a seventh gene set comprising FOS, GPX1, GPX3, DUSP1, GPX4,PRDX1, PRDX3, PRDX4, PRDX5, and S100A9; b) detecting a presence of lupus in the subject based on enrichment of the expression of genes in the gene set; and (c) administering to the subject a pharmaceutical agent capable of treating the lupus, wherein the pharmaceutical agent comprises baricitinib, carfilzomib,curcumol, decernotinib, delgocitinib, ruxolitinib, solicitinib, tofacitinib, upadacitinib, bortezomib, densosumab, filgotinib, idelalisib, KZR-616,peficitinib, sirolimus, everolimus, temsirolimus, adalimumab, AMG-811, BMS- 986165, certolizumab, dacomitinib, etanercept, iguratimod, infliximab,tabalumab, trofinetide, coenzyme Q10 (ubiquinoine) mipsagargin, resveratrol, N- acetyl L-cysteine, SKQ1, ubiquinone, mitoVitE, mitoTEMPO, vitamin E,vitamin C, ALT-2074, ebselen, GC4419, cyclosporin, metformin, phenformin,BAY84-2243, CAI, ME344, fenofibrate, lonidamine, arsenic trioxide,atovaquone, hydrocortisone, alpha-TOS, or thapsigargin (extra-solution activity as noted below, see MPEP 2106.05(g)). Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2). Subject Matter Eligibility Criteria – Step 2A – Prong Two: Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(1(A). In the present case, there are no additional limitations to integrate the at least one abstract idea into a practical application. The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below: Claim 2-3, 5, 21-28: The claim specifies genes and data set, which further narrows the abstract idea. Claim 10: The claim specifies the pharmaceutical agent reducing severity, which further narrows the abstract idea. Claim 14-15: The claim specifies the biological sample, which further narrows the abstract idea. Claim 19-20: The claim specifies the subject having lupus or risk of lupus, which further narrows the abstract idea. Claim 29-33: The claim specifies assaying biological sample, which is an extra-solution activity. Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea. Subject Matter Eligibility Criteria – Step 2B: Regarding Step 2B of the Alice/Mayo test, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-3, 5, 10, 14-15, and 19-33 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 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 – (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-3, 5, 10, 14-15, and 19-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Andrade et al. (WO 2024/044500). As per claim 1, Andrade teaches a method for treating lupus in a subject, the method comprising: a) analyzing a data set comprising or derived from gene expression measurements of a plurality of genes selected from a gene set to determine whether expression of genes in the gene set is enriched in a biological sample obtained or derived from the subject (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.), wherein the gene set is selected from: (i) a first gene set comprising COX17, COX6A2, COX6B1, NDUFA5, NDUFA9, NDUFAB1, NDUFAF2, UQCR10, UQCRQ, and ATP5MG (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.); (ii) a second gene set comprising ClQA, ClQB, ClQC, C2, C3, C4BPA,C4BPB, C5, C7, C6, C8a, C9, and CFP(Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.); (iii) a third gene set comprising COX6B1, COX17, NDUFA5, COX6A2,NDUFA9, NDUFAB1, NDUFAF2, UQCR10, and UQCRQ (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.); (iv) a fourth gene set comprising ACO2, CS, DLAT, DLD, DLST, FH,GLUD1, IDH1, IDH2, IDH3A, IDH3B, IDH3G, MDH2, MPC1, MPC2,OGDH, OGDHL, PDHA1, PDHA2, PDHB, PDHX, PDK1, PDK2, PDK3,PDK4, PDP1, PDP2, PDPR, SDHA, SDHAF1, SDHAF2, SDHAF3,SDHAF4, SDHB, SDHC, SDHD, SUCLA2, SUCLG1, SUCLG2, and SUGCT (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.); (v) a fifth gene set comprising AKR1A, ALDH1A1, ALDH2, ALDOB, ENOl, FBP1, G6PD, GALE, GAPDH, GOT1, HKDC1, LDHB, PCK1,PFKFB2, PFKP, PGM1, PKLR, RGN, SLC2A1, SLC2A5, and SLC37A4;(vi) a sixth gene set comprising ABCD1, ABCD2, ABCD3, ACAA2,ACACB, ACAD11, ACADL, ACADM, ACADS, ACADVL, ACAT1,ACAT2, ACOX1, ACOX2, ACOX3, ACOXL, ACSBG2, ACSL5, ADIPOQ, AKT2, AUH, BDH2, CPT1A, CPT2, CROT, DECR1, ECHDC1, ECHDC2,ECHS1, ECIl, ECI2, EHHADH, ETFA, ETFB, ETFDH, FABP1, GCDH,HADH, HADHA, HADHB, HIBCH, HSD17B4, IRS1, IRS2, IVD, LEP, PEX2, PEX5, PEX7, SESN2, SLC25A17, SLC27A2, and TWIST1; and (vii) a seventh gene set comprising FOS, GPX1, GPX3, DUSP1, GPX4,PRDX1, PRDX3, PRDX4, PRDX5, and S100A9 (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.); b) detecting a presence of lupus in the subject based on enrichment of the expression of genes in the gene set (Andrade: para. 97; Detecting systemic lupus from a sample by analyzing the sample collected.); and (c) administering to the subject a pharmaceutical agent capable of treating the lupus, wherein the pharmaceutical agent comprises baricitinib, carfilzomib,curcumol, decernotinib, delgocitinib, ruxolitinib, solicitinib, tofacitinib, upadacitinib, bortezomib, densosumab, filgotinib, idelalisib, KZR-616,peficitinib, sirolimus, everolimus, temsirolimus, adalimumab, AMG-811, BMS- 986165, certolizumab, dacomitinib, etanercept, iguratimod, infliximab,tabalumab, trofinetide, coenzyme Q10 (ubiquinoine) mipsagargin, resveratrol, N- acetyl L-cysteine, SKQ1, ubiquinone, mitoVitE, mitoTEMPO, vitamin E,vitamin C, ALT-2074, ebselen, GC4419, cyclosporin, metformin, phenformin,BAY84-2243, CAI, ME344, fenofibrate, lonidamine, arsenic trioxide,atovaquone, hydrocortisone, alpha-TOS, or thapsigargin (Andrade: para. 98). As per claim 2, the method of claim 1 is as described. Andrade teaches wherein the plurality of genes comprises at least 3 genes in the gene set (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.). As per claim 3, the method of claim 1 is as described. Andrade teaches wherein the plurality of genes comprises all genes in the gene set (Andrade: para. 141; Gene set enrichment analysis is done and list of genes are determined.). As per claim 5, the method of claim 1 is as described. Andrade teaches wherein the data set is derived from the gene expression measurements using GSVA, gene set enrichment analysis (GSEA), enrichment algorithm, multiscale embedded gene co-expression network analysis (MEGENA), weighted gene co-expression network analysis (WGCNA), differential expression analysis, Z-score, log2 expression analysis, or any combination thereof (Andrade: para. 56; para. 160). As per claim 10, the method of claim 1 is as described. Andrade teaches wherein the pharmaceutical agent reduces a severity of lupus (Andrade: para. 89; para. 98-100; Reduce risk if low systemic lupus by reducing dosage.). As per claim 14, the method of claim 1 is as described. Andrade teaches wherein the biological sample comprises a blood sample, isolated peripheral blood mononuclear cells (PBMCs), a tissue biopsy sample, or any derivative thereof (Andrade: para. 101; para. 83). As per claim 15, the method of claim 14 is as described. Andrade teaches wherein the biological sample comprises a blood sample, isolated peripheral blood mononuclear cells (PBMCs), or any derivative thereof (Andrade: para. 101; para. 83). As per claim 19, the method of claim 1 is as described. Andrade teaches wherein the subject is asymptomatic for lupus. As per claim 20, the method of claim 1 is as described. Andrade teaches wherein the subject has Asian ancestry and/or European ancestry (Andrade: para. 153; table 1). As per claim 21, the method of claim 1 is as described. Andrade teaches wherein the plurality of genes of the gene expression measurements are selected from at least 2 gene sets in (i)-(vi) (Andrade: para. 141). As per claim 22, the method of claim 21 is as described. Andrade teaches wherein the plurality of genes is selected from at least 3 gene sets in (i)-(vi) (Andrade: para. 141). As per claim 23, the method of claim 22 is as described. Andrade teaches wherein the plurality of genes is selected from at least 4 gene sets in (i)-(vi) (Andrade: para. 141). As per claim 24, the method of claim 21 is as described. Andrade teaches wherein the plurality of genes comprises at least two genes from the at least 2 gene sets (Andrade: para. 141). As per claim 25, the method of claim 1 is as described. Andrade teaches wherein the gene set comprises the first gene set, and wherein the pharmaceutical agent comprises resveratrol, N-acetyl L-cysteine, SKQ 1, ubiquinone, mitoVitE, mitoTEMPO, vitamin E, or vitamin C (Andrade: para. 141). As per claim 26, the method of claim 1 is as described. Andrade teaches wherein the gene set comprises the second gene set, and wherein the pharmaceutical agent comprises metformin, phenformin, BAY84-2243, CAI,ME344, fenofibrate, lonidamine, arsenic trioxide, atovaquone, hydrocortisone, alpha- TOS, or thapsigargin (Andrade: para. 141). As per claim 27, the method of claim 1 is as described. Andrade teaches wherein the gene set comprises the fourth gene set, and wherein the pharmaceutical agent comprises cyclosporin (Andrade: para. 141). As per claim 28, the method of claim 1 is as described. Andrade teaches wherein the gene set comprises the sixth gene set, and wherein the pharmaceutical agent comprises resveratrol, N-acetyl L-cysteine,SKQ 1, ubiquinone, mitoVitE, mitoTEMPO, vitamin E, vitamin C, ALT-2074, ebselen, or GC4419 (Andrade: para. 141). As per claim 29, the method of claim 1 is as described. Andrade teaches further comprising assaying the biological sample to obtain the gene expression measurements of the plurality of genes (Andrade: para. 72). As per claim 30, the method of claim 29 is as described. Andrade teaches wherein the assaying comprises array hybridization (Andrade: para. 72). As per claim 31, the method of claim 29 is as described. Andrade teaches wherein the assaying comprises polymerase chain reaction (Andrade: para. 72). As per claim 32, the method of claim 29 is as described. Andrade teaches wherein the assaying comprises ribonucleic acid (RNA) sequencing (Andrade: para. 72; para. 141-142). As per claim 33, the method of claim 29 is as described. Andrade teaches wherein the assaying comprises selectively enriching the biological sample for the plurality of genes (Andrade: para. 128-135). Response to Arguments Applicant's arguments filed for claims 1-3, 5, 10, 14-15, and 19-33 under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues that the “administering” step provides a treatment and therefore, a practical application. When considering if a particular treatment and prophylaxis is considered a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2).• Factor A. The treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Here, the treatment delivered is not specified.• Factor B. The treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. As stated above, because the delivered treatment type is not defined, any possible treatment could not reasonably be considered known in the art as a treatment for any lupus condition. • Factor C. The treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The administering step according to a generated treatment plan is well known, nominally related to the inventive concept of creating the treatment plan, and amount to necessary data output similar to that of In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016). Therefore, the claims only recite the prophylactic step as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception. Applicant’s amendments, filed 3/17/2026, with respect to 35 U.S.C. 112 have been fully considered and are persuasive. The 35 U.S.C. 112 rejection of claims 1-4, 5, 10, 14-15, and 19-20 has been withdrawn. Applicant's arguments filed for claims 1-3, 5, 10, 14-15, and 19-33 under 35 U.S.C. 102 have been fully considered but they are not persuasive. Applicant provides conclusory arguments and therefore, Examiner maintains the rejection. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cesaroni et al. – U.S. Publication No. 2023/0279097 – Teaches treating patients with systemic lupus. Colley et al. – U.S. Publication No. 2021/0090694 – Teaches a system for generating a genetic sequence data for cells and developing a treatment. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm. 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, Marc Jimenez can be reached at (571) 272-4530. 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. /SHEETAL R PAULSON/Primary Examiner, Art Unit 3681
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Prosecution Timeline

May 06, 2025
Application Filed
Sep 19, 2025
Non-Final Rejection mailed — §101, §102
Mar 17, 2026
Response Filed
Apr 28, 2026
Final Rejection mailed — §101, §102 (current)

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METHODS AND SYSTEMS OF EMBODIMENT TRAINING IN A VIRTUAL-REALITY ENVIRONMENT
7y 3m to grant Granted Jul 28, 2026
Patent 12688914
METHODS AND SYSTEMS FOR IMPLEMENTING PERSONALIZED HEALTH APPLICATION
2y 6m to grant Granted Jul 21, 2026
Patent 12676222
Tracking Use of Medical Device
2y 6m to grant Granted Jul 07, 2026
Patent 12671001
TELEHEALTH SERVICE DELIVERY SYSTEM
4y 2m to grant Granted Jun 30, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
39%
Grant Probability
55%
With Interview (+16.2%)
4y 4m (~3y 1m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 666 resolved cases by this examiner. Grant probability derived from career allowance rate.

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