Prosecution Insights
Last updated: April 19, 2026
Application No. 16/992,569

SYSTEMS AND METHODS FOR USING THE SPATIAL DISTRIBUTION OF HAPLOTYPES TO DETERMINE A BIOLOGICAL CONDITION

Final Rejection §101
Filed
Aug 13, 2020
Examiner
LIU, GUOZHEN
Art Unit
1686
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
10X Genomics, Inc.
OA Round
7 (Final)
50%
Grant Probability
Moderate
8-9
OA Rounds
4y 8m
To Grant
75%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
47 granted / 95 resolved
-10.5% vs TC avg
Strong +25% interview lift
Without
With
+25.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 8m
Avg Prosecution
39 currently pending
Career history
134
Total Applications
across all art units

Statute-Specific Performance

§101
37.1%
-2.9% vs TC avg
§103
25.2%
-14.8% vs TC avg
§102
7.3%
-32.7% vs TC avg
§112
19.8%
-20.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 95 resolved cases

Office Action

§101
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Applicant's Amendment/Request for Reconsideration-After Non-Final Rejection filing of 3 February 2026, has been entered and fully considered. Status of Claims Claims 5, 32-37, 43-44, 46-50 and 56-61 are cancelled. Claims 1-4, 6-31, 38-42, 45, 51-55 and 62-69 are pending and are examined on the merits. 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, or 365(c) is acknowledged. Priority of US application 62/886,238 filed 08/13/2019 is acknowledged. Withdrawn Rejections/Objections The objection to claim 61 in the Office action mailed 5 November 2025 is withdrawn in view of claim amendments filed 3 February 2026. The rejections to claims 1-4, 6-31, 38-42, 45, 51-55 and 61-69 under 35 U.S.C. 112(b) in the Office action mailed 5 November 2025 is withdrawn in view of claim amendments filed 3 February 2026. Claim Rejections - 35 USC § 101 This 101 rejection is maintained from the previous Office action. Minor modifications are applied to accommodate claim amendments. 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 1-4, 6-31, 38-42, 45, 51-55 and 62-69 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Step 1: Process, Machine, Manufacture or Composition Claims 1-4, 6-31, 38-42, 45, 51-55 and 62-69 are drawn to a process, here a "method," for characterizing a biological condition of a subject. Step 2A Prong One: Identification of Judicial Exceptions The claim(s) recite(s): B) For each respective loci in a plurality of loci, performing a procedure that comprises: i) identifying a corresponding subset of the plurality of sequence reads that map to the respective loci based upon a mapping of the plurality of sequence reads to a reference sequence, ii) performing an alignment of each respective sequence read in the corresponding subset of the plurality of sequence reads to the reference sequence thereby determining a haplotype identity for the respective sequence read from among a corresponding set of haplotypes for the respective loci, and iii) categorizing each respective sequence read in the corresponding subset of the plurality of sequence reads by the spatial barcode of the respective sequence read and by the haplotype identity; thereby determining a spatial distribution of one or more haplotypes in the sectioned tissue sample, wherein the spatial distribution includes, for each position in the two- dimensional array of positions, an abundance of each haplotype in the set of haplotypes for each loci in the plurality of loci; Step B recites sequence reads analysis through mapping and comparing to reference that leads to categorization and determination of spatial distribution of one or more haplotypes in the sectioned tissue sample. These are data analysis and decision-making processes following the data results, which can be achieved in the human mind, and/or with the aid of a pen and paper. Therefore, this step equates to an abstract idea of mental processes. C) constructing, using the spatial distribution, a reference matrix and an alternative matrix that are each dimensioned by the plurality of loci along a first dimension and the set of capture probe pluralities in the second dimension. Step C recites data reorganization (of existing data) into two matrixes, which is a data manipulation activity. This step can be accomplished in the human mind. Therefore, this step equates to an abstract idea of mental processes. E) using a computer processor to process an image of the stained tissue sample to generate a mask of the two-dimensional array of positions, wherein the mask comprises, for each respective capture probe plurality in the set of capture probe pluralities, at least one label assigned from a set of enumerated labels based on a color in the image at the location of the respective capture probe, wherein a first label in the set of enumerated labels is an abnormal state and a second label in the set of enumerated labels is a healthy state; and Step E reads on stained tissue image data analysis that results in labels of abnormal or healthy states, wherein the tissue image is standardized into a mask of the two-dimensional array of positions. Under a Broadest Reasonable Interpretation (BRI), step E equates to a judging (or decision-making) process that leads to two different class labels (abnormal or healthy) for array positions; step E also equates to image data manipulation so to prepare standardized input (a mask of the two-dimensional array of positions) for model training. These two processes can both be achieved in human mind. Therefore, this step equates to an abstract idea of mental processes. F) using the at least one label assignment for each respective capture probe plurality in the set of capture probe pluralities of the mask, the first matrix, and the second matrix to determine one or more first portions of the tissue sample having the abnormal state and second one or more portions of the tissue sample having the healthy state at single cell resolution or better. Step F reads on data analysis that results in determination of abnormal/healthy states for tissue samples at different array positions. Under a BRI, step F equates to a judging (or decision-making) process which can be achieved in human mind. Therefore, this step equates to an abstract idea of mental processes. Claim 11 recites: wherein a respective loci in the plurality of loci is biallelic and the corresponding set of haplotypes for the respective loci consists of a first allele and a second allele. This claim further limit the loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 12 recites: wherein the respective loci include a heterozygous single nucleotide polymorphism (SNP), a heterozygous insert, a heterozygous deletion, or a gene fusion. This claim further limit the loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 15 recites: wherein the corresponding subset of the plurality of sequence reads that map to the respective loci comprises 5 or more sequence reads. This claim further limit the subset of reads, which is still part of the data analysis Therefore this claim equates to an abstract idea of mental processes. Claim 16 recites: wherein the plurality of loci comprises between two and 100 loci, more than 10 loci, or more than 100 loci. This claim further limit the loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 17 recites: wherein the corresponding spatial barcode encodes a unique predetermined value selected from the set { 1, ..., 1024}, { 1, ..., 4096},{1,...16384}, {1, ..., 65536}, {1, ..., 262144}, {1, ..., 1048576}, {1, ..., 4194304}, {1,...16777216}, {1, ..., 67108864}, or {1, ..., 1 x 1012}. This claim further limit the barcode sequences, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 20 recites: the method further comprising retrieving the plurality of loci from a lookup table, file or data structure prior to the performing B). This claim further limit the method retrieving loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 21 recites: wherein the alignment is a local alignment that aligns the respective sequence read to the reference sequence using a scoring system that (i) penalizes a mismatch between a nucleotide in the respective sequence read and a corresponding nucleotide in the reference sequence in accordance with a substitution matrix and (ii) penalizes a gap introduced into an alignment of the sequence read and the reference sequence. This claim further limit the alignment method, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 22 recites: wherein the local alignment is a Smith-Waterman alignment. This claim further limit the alignment method, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 23 recites: wherein the reference sequence is a portion of a reference genome. This claim further limit the reference, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 24 recites: the method further comprising removing, from the plurality of sequence reads, one or more sequence reads that do not overlay any loci in the plurality of loci. This claim further limit the alignment method, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 25 recites: wherein the plurality of sequence reads is RNA-sequence reads and wherein the removing comprises removing one or more sequence reads in the plurality of sequence reads that overlap a splice site in the reference sequence. This claim further limit the sequence reads, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 26 recites: wherein the plurality of loci includes one or more loci on a first chromosome and one or more loci on a second chromosome other than the first chromosome. This claim further limit the loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 51 recites: the biological condition is absence or presence of a disease. This claim further limit the biological condition, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 52 recites: the biological condition is a type of a cancer This claim further limit the biological condition, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 53 recites: the biological condition is stage of a disease This claim further limit the biological condition, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 54 recites: the biological condition is stage of a cancer This claim further limit the biological condition, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 63 recites: wherein the corresponding subset of the plurality of sequence reads that map to the respective loci comprises 1000 or more sequence reads. This claim further limit the sequence reads, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 64 recites: wherein the plurality of loci comprises more than 500 loci. This claim further limit the loci, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 65 recites: wherein the reference sequence is all of a reference genome. This claim further limit the reference sequence, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. Claim 69 recites: wherein the using F) determines the one or more first portions of the tissue sample having the abnormal state and the one or more second portions of the tissue sample having the healthy state at a resolution of between 1 micron and 10 microns. This claim further limit the resolution, which is still part of the data analysis. Therefore this claim equates to an abstract idea of mental processes. In summary, claims recite multiple elements that describe the probes, reads, barcodes, loci and reference sequence related in data analysis, and the resolution These are part of the judicial exceptions. These judicial exception elements also have antecedent basis in claim 1. Step 2A Prong Two: Consideration of Practical Application The claims result in a process of characterizing the biological condition of the subject samples, which reads on data information. The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application. 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. Step 2B: 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 elements are drawn to: A) obtaining a plurality of sequence reads from a two-dimensional array of positions on a substrate (claim 1). D) staining the tissue sample with at least one dye (claim 1); the sectioned tissue sample is not removed from the substrate (claim 2); a capture probe plurality in the set of capture probe pluralities comprises a capture domain (claim 3); each capture probe in a capture probe plurality in the set of capture probe pluralities comprises a cleavage domain (claim 4); each capture probe in a capture probe plurality in the set of capture probe pluralities does not comprise a cleavage domain and is not cleaved from the array (claim 6); the one or more analytes comprises DNA or RNA (claim 7); each capture probe plurality in the set of capture probe pluralities is attached directly or attached indirectly to the substrate (claim 8); the sequencing in obtaining A) comprises in-situ sequencing of the two-dimensional array of positions on the substrate (claim 9); the sequencing in obtaining A) comprises high-throughput sequencing (claim 10); the one or more analytes comprise five or more analytes (claim 13); the plurality of sequence reads comprises 50,000 or more sequence reads (claim 14); the spatial barcode in the respective sequence read is localized to a contiguous set of oligonucleotides within the respective sequencing read (claim 18); the contiguous set of oligonucleotides is an N- mer, wherein N is an integer selected from the set {4, ..., 20} (claim 19); wherein the plurality of sequence reads includes 3'-end or 5'-end paired sequence reads (claim 27); each respective capture probe plurality includes 2000 or more probes. each probe in the respective capture probe plurality includes a poly-A sequence or a poly-T sequence and the corresponding spatial barcode that characterizes the respective capture probe plurality (claim 29); each probe in the respective capture probe plurality includes the same spatial barcode from the plurality of spatial barcodes (claim 30). each probe in the respective capture probe plurality includes a different spatial barcode from the plurality of spatial barcodes (claim 31); the set of capture probe pluralities comprises more than 2000 capture probe pluralities (claim 38); the one or more analytes are mRNA transcripts (claim 39); the one or more analytes is a plurality of analytes, each probe in the 1000 or more probes of a respective capture probe plurality in the set of capture probe pluralities includes a capture domain that is characterized by a capture domain type in a plurality of capture domain types, and each respective capture domain type in the plurality of capture domain types is configured to bind to an analyte in the plurality of analytes (claim 40); the plurality of capture domain types comprises between 5 and 15,000 capture domain types and the 1000 or more probes of the respective capture probe plurality includes at least five, at least 10, at least 100, or at least 1000 probes for each capture domain type in the plurality of capture domain types (claim 41); the one or more analytes is a plurality of different analytes, and each probe in the 1000 or more probes of a respective capture probe plurality in the set of capture probe pluralities includes a capture domain that is characterized by a single capture domain type configured to bind an analyte in the plurality of analytes in an unbiased manner (claim 42); a shape of each capture probe plurality in the set of capture probe pluralities on the substrate is a closed-form shape (claim 45); the obtaining A) comprises genome-wide transcript coverage obtained from a 5′ or 3′ single cell gene expression workflow (claim 55); the one or more analytes comprise 1000 or more analytes (claim 62); the set of capture probe pluralities comprises more than 4000 capture probe pluralities (claim 66); each position in the two-dimensional array of positions represents a region having a maximum dimension of between 1 µm and 50 µm on the substrate (claim 67); and each position in the two-dimensional array of positions represents a region having a maximum dimension of between 1 µm and 30 µm on the substrate (claim 68). In summary, the claims recite multiple elements that describe the tissue samples, capture probes, spatial barcodes, loci, sequencing, sequence reads, analytes, and biological conditions. These are additional elements and they all have antecedent basis in claim 1. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because spatial contacting sectioned tissues, capturing targets using probes, from biological materials of certain conditions, and staining the tissue samples, sequencing and acquiring sequence reads of the captured targets, are well-understood, routine, and conventional activities previously known to the pertinent industry. The conventionality of these additional elements are further evidenced in the following references (emphasis added): Lee JH, Daugharthy ER, Scheiman J, Kalhor R, Yang JL, Ferrante TC, Terry R, Jeanty SS, Li C, Amamoto R et al. (2014) Highly multiplexed subcellular RNA sequencing in situ. Science 343, 1360–1363. Previously cited. Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M et al. (2016) Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science 353, 78–82. Previously cited. Salmén, Fredrik, et al. "Barcoded solid-phase RNA capture for Spatial Transcriptomics profiling in mammalian tissue sections." Nature protocols 13.11 (2018): 2501-2534. Previously cited. Giacomello, Stefania, and Joakim Lundeberg. "Preparation of plant tissue to enable Spatial Transcriptomics profiling using barcoded microarrays." Nature Protocols 13.11 (2018): 2425-2446. Previously cited. Strell, Carina, et al. "Placing RNA in context and space–methods for spatially resolved transcriptomics." The FEBS journal 286.8 (2019): 1468-1481. Previously cited. Moncada, Reuben, et al. "Integrating single-cell RNA-Seq data with spatial transcriptomics in pancreatic ductal adenocarcinoma." BioRxiv (2019): 254375. Previously cited. So, Alex et. al. “Spatial mapping of nucleic acid sequence information,” WO2017019456A2, Published 2017-02-02. Previously cited. Frisen, Jonas et. al. “Method And Product For Localized Or Spatial Detection Of Nucleic Acid In A Tissue Sample,” US 10030261 B2, Date Published 2018-07-24. Previously cited. Fodor, Stephen PA et. al. “Spatially Addressable Molecular Barcoding,” US 9727810 B2, Date Published 2017-08-08. Previously cited. These references demonstrated that obtaining a plurality of sequence reads from a two-dimensional array of positions on a substrate is practiced for several years by the time the instant invention is filed. Particularly “transcriptomics profiling” means obtaining a plurality of sequence reads (here from a two-dimensional array of positions (special) on a substrate). The barcode (sequence specific oligo-nucleotides) is a way to recode location (or cell) specific position and imaging of fluorescent stain (usually correlated to the barcodes) is a routine step in this technical area. Frisen provides: (2) As used herein the term “multiple” means two or more, or at least two, e.g. 3, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 400, 500, 1000, 2000, 5000, 10,000, or more etc. Thus for example, the number of capture probes may be any integer in any range between any two of the aforementioned numbers. It will be appreciated however that it is envisaged that conventional-type arrays with many hundreds, thousands, tens of thousands, hundreds of thousands or even millions of capture probes may be used. (3) Thus, the methods outlined herein utilize high density nucleic acid arrays comprising “capture probes” for capturing and labelling transcripts from all of the single cells within a tissue sample e.g. a thin tissue sample slice, or “section”. The tissue samples or sections for analysis are produced in a highly parallelized fashion, such that the spatial information in the section is retained. The captured RNA (preferably mRNA) molecules for each cell, or “transcriptomes”, are transcribed into cDNA and the resultant cDNA molecules are analyzed, for example by high throughput sequencing. The resultant data may be correlated to images of the original tissue samples e.g. sections through so-called barcode sequences (or ID tags, defined herein as positional domains) incorporated into the arrayed nucleic acid probes. (4) High density nucleic acid arrays or microarrays are a core component of the spatial transcriptome labelling method described herein. A microarray is a multiplex technology used in molecular biology. A typical microarray consists of an arrayed series of microscopic spots of oligonucleotides (hundreds of thousands of spots, generally tens of thousands, can be incorporated on a single array). The distinct position of each nucleic acid (oligonucleotide) spot (each species of oligonucleotide/nucleic acid molecule) is known as a “feature” (and hence in the methods set out above each species of capture probe may be viewed as a specific feature of the array; each feature occupies a distinct position on the array), and typically each separate feature contains in the region of picomoles (10.sup.−12 moles) of a specific DNA sequence (a “species”), which are known as “probes” (or “reporters”). Typically, these can be a short section of a gene or other nucleic acid element to which a cDNA or cRNA sample (or “target”) can hybridize under high-stringency hybridization conditions. However, as described below, the probes of the present invention differ from the probes of standard microarrays. (5) In gene expression microarrays, probe-target hybridization is usually detected and quantified by detection of visual signal, e.g. a fluorophore, silver ion, or chemiluminescence-label, which has been incorporated into all of the targets. (6) The intensity of the visual signal correlates to the relative abundance of each target nucleic acid in the sample. Since an array can contain tens of thousands of probes, a microarray experiment can accomplish many genetic tests in parallel. Which teaches thousands of captures probes at thousands spots that are recorded by barcode. Here the “feature” is equivalent to “each respective capture probe plurality in the set of capture probe pluralities” recited in instant claim 1 step A). Frisen showed the sequence reads can easily go to 10,000 or more in Fig. 7 which 20 locations (here the Barcode “Tag1 through Tag20) each has at least 616 qualifying reads generated). So used "spatial address," "spatial tag" or "spatial index," in reference to a nucleotide sequence, means an address, tag or index encoding spatial information related to the region or location of origin of an addressed, tagged, or indexed nucleic acid in a tissue sample ([0099]). “Accordingly, an index is useful as a barcode where different members of the same molecular species can contain the same index and where different species within a population of different polynucleotides can have different indices” ([0098]). Hence barcode probes are also conventionally used by So. So practiced staining to tissue samples ([00125]). The references cited under Step 2B evidence that hybrid capture and ;large-scale sequencing from sectioned tissue samples are well-known. The conventionality of the sequencing technologies that preserve the spatial coordinates of RNA and DNA sequences with up to subcellular resolution, thus enabling back mapping of sequencing reads to the stained original histological context, are exemplified by the above references. 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 Applicant’s Argument In the Remarks filed 3 February 2026, Applicant argues (pages 17-20) that claims are not directed to judicial exceptions at Step 2A/Prong two (page 18, 2nd para through page 19, 3rd pong) because the judicial exceptions are integrated into a practical application. In response, Applicant’s argument is not persuasive. As discussed above, the claims result in a process of characterizing the biological condition of the subject samples, which reads on data information. The judicial exception is not captured or reflected in any of the following two identified additional elements: A) obtaining a plurality of sequence reads from a two-dimensional array of positions on a substrate. D) staining the tissue sample with at least one dye. Characterizing the biological condition of the subject samples is not an additional element but an abstract idea. Improvement to an abstract idea does not integrate the claims into a practical application at Step 2A/Prong Two. In the Remarks, Applicant argues (page 18 through page 19) that the additional elements in step (A) to (C) in combination with the analysis in step (D) through (F) integrate the judicial exception into a practical application that improves the technical field of spatially characterizing a biological condition of a subject. Applicant argues that this is consistent with Desjardins. In response, Applicant’s argument is not persuasive. Among the major steps (A) through (F), steps (A) and (D) are additional elements, step (B) and (C) are about data analysis of the data acquired in step (A). The data analysis pertains to step (B) and (C) is unrelated to step (D) staining tissue sample. Step (E) analyzes data from step (B), (C) and (E), and finally these analytic results are integrated in step (F) as an output to spatially characterize the biological condition of the subject. As discussed above, Creating an output is an insignificant extra-solution activity. Characterizing the biological condition of the subject samples is not an additional element but an abstract idea. Improvement to an abstract idea does not integrate the claims into a practical application at Step 2A/Prong Two. In the Remarks, Applicant argues (page 19, 4th para through page 20, 1st para) that claims are patent eligible under Step 2B because “claim 1 recite significantly more than any judicial exception.” In response, Applicant’s argument is not persuasive. As discussed above over the 101 rejection, the identified additional elements: A) obtaining a plurality of sequence reads from a two-dimensional array of positions on a substrate. D) staining the tissue sample with at least one dye. are not sufficient to amount to significantly more than the judicial exception because the conventionality of these additional elements are evidenced in the references listed in the 101 rejection section Step 2B. In the Remarks, Applicant argues (page 20, 2nd para) that claims are patent eligible under Step 2B because “The claimed invention solves technical problems in spatially charactering a biological condition of a subject at single cell resolution”. In response, Applicant’s argument is not persuasive. claim 1 recite significantly more than any judicial exception. “Spatially charactering a biological condition of a subject” reads on information, which is directed to a judicial exception. Claims cannot be integrated into a practical application by a judicial exception. Only additional elements can integrate claims into a 101 eligible application. Therefore, the 101 rejection is maintained. Conclusion No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUOZHEN LIU whose telephone number is (571)272-0224. The examiner can normally be reached Monday-Friday 8-5. 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, Larry D Riggs can be reached at (571) 270-3062. 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. /GL/ Patent Examiner Art Unit 1686 /Anna Skibinsky/ Primary Examiner, AU 1635
Read full office action

Prosecution Timeline

Aug 13, 2020
Application Filed
Jan 13, 2023
Non-Final Rejection — §101
May 31, 2023
Response Filed
Aug 15, 2023
Final Rejection — §101
Dec 20, 2023
Request for Continued Examination
Dec 27, 2023
Response after Non-Final Action
Mar 22, 2024
Non-Final Rejection — §101
Jun 12, 2024
Response Filed
Sep 30, 2024
Non-Final Rejection — §101
Jan 09, 2025
Response Filed
Apr 17, 2025
Final Rejection — §101
Jul 16, 2025
Request for Continued Examination
Jul 18, 2025
Response after Non-Final Action
Oct 27, 2025
Non-Final Rejection — §101
Feb 03, 2026
Response Filed
Mar 20, 2026
Final Rejection — §101 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12590326
METHODS FOR FRAGMENTOME PROFILING OF CELL-FREE NUCLEIC ACIDS
2y 5m to grant Granted Mar 31, 2026
Patent 12535399
CELL SORTING DEVICE AND METHOD
2y 5m to grant Granted Jan 27, 2026
Patent 12499971
SYSTEMATIC SCREENING AND MAPPING OF REGULATORY ELEMENTS IN NON-CODING GENOMIC REGIONS, METHODS, COMPOSITIONS, AND APPLICATIONS THEREOF
2y 5m to grant Granted Dec 16, 2025
Patent 12393660
DNA Access Control Systems
2y 5m to grant Granted Aug 19, 2025
Patent 12340873
METHODS FOR MULTI-RESOLUTION ANALYSIS OF CELL-FREE NUCLEIC ACIDS
2y 5m to grant Granted Jun 24, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

8-9
Expected OA Rounds
50%
Grant Probability
75%
With Interview (+25.4%)
4y 8m
Median Time to Grant
High
PTA Risk
Based on 95 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month