Prosecution Insights
Last updated: April 19, 2026
Application No. 17/930,460

COMPOSITIONS AND METHODS FOR DIAGNOSING COLORECTAL CANCER

Non-Final OA §101§102§112
Filed
Sep 08, 2022
Examiner
ROSSI, VY BUI
Art Unit
1685
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Genegeniedx Corporation
OA Round
1 (Non-Final)
33%
Grant Probability
At Risk
1-2
OA Rounds
4y 7m
To Grant
80%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
13 granted / 39 resolved
-26.7% vs TC avg
Strong +47% interview lift
Without
With
+46.6%
Interview Lift
resolved cases with interview
Typical timeline
4y 7m
Avg Prosecution
22 currently pending
Career history
61
Total Applications
across all art units

Statute-Specific Performance

§101
27.0%
-13.0% vs TC avg
§103
23.2%
-16.8% vs TC avg
§102
11.2%
-28.8% vs TC avg
§112
23.6%
-16.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 39 resolved cases

Office Action

§101 §102 §112
CTNF 17/930,460 CTNF 98488 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. Election/Restrictions Applicant’s election without traverse of Group III , claims 15-19 , drawn to a computer-implemented method for identifying a discriminative region within a group of sequences.in the reply filed 11/17/2025 is acknowledged. Election was made without traverse in the Applicant's remarks, filed 11/17/2025. Claims 1-14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim Status Claims 1-20 are currently pending. 08-06 Claims 1-14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Applicant's remarks, filed 11/17/2025. Claims 15-19 are under examination herein. Claims 15-19 are rejected. Priority This application claims benefit of PRO 63/241,540, filing date 09/08/2021 , is acknowledged. In this action, all claims 15-19 are examined for an effective filing date of 09/08/2021 . In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s). Information Disclosure Statement No Information Disclosure Statements are filed, see Objection: specification. . Drawings The Drawings submitted 09/22/2022 are accepted. Specification 07-29 AIA The disclosure is objected to because of the following informalities: The listing of references in the specification, e.g. [0079, 0092], is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited on a PTO-1449 or by the examiner on form PTO-892, they have not been considered. Applicant should review the entire disclosure for references and submit in an Information Disclosure Statement . Appropriate correction is required. 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 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon and abstract ideas without significantly more. The instant rejection reflects the framework as outlined in the MPEP at 2106.04: Framework with which to Evaluate Subject Matter Eligibility : (1) Are the claims directed to a process, machine, manufacture, or composition of matter; (2A) Prong One: Do the claims recite a judicially recognized exception, i.e . a law of nature, a natural phenomenon, or an abstract idea; Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and (2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept. Framework Analysis as Pertains to the Instant Claims: With respect to step ( 1 ): yes, the claims are directed to a method for colorectal cancer evaluation with gut microbe genetic biomarker analysis, therefore the answer is "yes". With respect to step ( 2A )( 1 ), the claims recite abstract ideas. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). In the instant application, the claims recite the following limitations that equate to an abstract idea with mental steps and mathematical concepts. With respect to the instant claims, under the step ( 2A )( 1 ) evaluation, the claims are found to direct to abstract ideas that fall into the grouping of mental processes (in particular steps for analyzing epigenetic information) and mathematical concepts (in particular mathematical relationships between epigenetic data). The claims directing to abstract ideas are as follows: Mental processes: Claim 15: identifying a discriminative region within the group, and a group of background sequences… identifying a pair of kmers,….retrieving all regions flanged by the pair of kmers in the target sequences; aligning the regions retrieved to determine that the regions are conserved; generating a consensus sequence based on the regions retrieved; determining that the consensus sequence does not occur in the group of background sequences; and retaining the consensus sequence as a discriminative region for the group of target sequences. Claim 17:designing a pair of primers for amplifying the discriminative region.. Claim 18: filtering the kmers before the step of identifying the pair of kmers according to a criterion selected from: the kmer occurs less than or more than a threshold percentage of the target sequences; the kmer has a homopolymer, dimer or trimer of more than a threshold; and the kmer has a GC content more than or less than a threshold. Mathematical concepts: Claim 15: decomposing each sequence within the group of target sequences into overlapping kmers, wherein each kmer has a length of 4 to 31; identifying a pair of kmers, wherein the pair of kmers occurs at most once in each sequence within the group of target polynucleotide sequences, the pair of kmers has a distance ranging from 20 to 1000, the pair of kmers are not identical, and the pair of kmers occur more than a threshold number of the target sequences; Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas. With respect to step ( 2A ), under the broadest reasonable interpretation (BRI), the instant claims a method for colorectal cancer evaluation with gut microbe genetic biomarker analysis. Instant claims are therefore directed to the judicial exceptions of abstract groupings, both mathematical (decomposing …overlapping kmers… identifying… pair of kmers are not identical… occur more than a threshold number) and mental processes ( identifying a discriminative region … identifying a pair of kmers,….retrieving all regions… aligning the regions retrieved to determine that the regions are conserved; generating a consensus sequence … determining that the consensus sequence… retaining the consensus sequence … designing a pair of primers… filtering the kmers … selected from: the kmer…) which can be performed with the human mind with pen and paper. Because the claims do recite judicial exceptions, direction under step ( 2A )( 2 ) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exception, the claim is said to fail to integrate into a practical application (MPEP 2106.04(d).III). With respect to the instant recitations, the claims recite the following additional elements considered for practical application : Claim 15: obtaining a plurality of sequences comprising a group of target sequences Claim 16: wherein the group of target polynucleotide sequences are genomic sequences of a bacterial species or a viral species; preferably, the bacterial species is a gut microbial species, and the viral species is HIV, HCV, or Covid-19. Claim 19: non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere instructions or field of use limitations (group of target polynucleotide sequences…genomic sequences of a bacterial species and the viral species is HIV, HCV, or Covid-19) to implement in the recited judicial exception and do not impart meaning to said recited judicial exception, such that is applied in a practical manner. Further with respect to the additional elements in the instant claims, these steps direct to mere data gathering and handling ( obtaining a plurality of sequences… ) to carry out the abstract idea without imposing any meaningful limitation on the abstract idea. Thereby these steps are insignificant extra-solutions activity steps and are insufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g). Further steps herein directed to additional non-abstract elements of computer components (non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor) do not describe any specific computational steps by which the “computer parts” [00102-00104] perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than generic computer elements used as a tool to perform the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, non-transitory computer readable medium .… are recited so generically that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)). None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application. As such, the claims are lastly evaluated using the step ( 2B ) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. The judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi). With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements ) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s). With respect to the instant recitations, the claims recite the following additional elements considered for inventive concepts : Claim 15: obtaining a plurality of sequences comprising a group of target sequences Claim 16: wherein the group of target polynucleotide sequences are genomic sequences of a bacterial species or a viral species; preferably, the bacterial species is a gut microbial species, and the viral species is HIV, HCV, or Covid-19. Claim 19: non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor These additional elements do not contribute significantly more to well-known and conventional steps to obtain genetic data, performed with routine laboratory equipment, and analyzed by one with ordinary skill in the art as of the effective filing date. The instant claims and references cited in the specification recite steps (k-mer analysis, microbe genome classifiers, genotype profiling of cancer) known in the art by molecular biologists: These limitations equate to well-understood, routine and conventional activities as evidenced by: Marçais G et al [2011: A fast, lock-free approach for efficient parallel counting of occurrences of k-mers. Bioinformatics 27.6: 764-770] teaches Jellyfish for standardized sequence partitioning with k-mer, k up to 31 bases (wherein each kmer has a length of 4 to 31) , counting with a lightweight, memory efficient, multithreaded hash table. O’Hara et al. US12,176,071: Systems and methods for ultra-fast identification and abundance estimates of microorganisms using a kmer-depth based approach and privacy-preserving protocols [PTO 892 cited] teaches using a k-mer based approach, with a reference k-mer library database of taxa specific markers and taxa unique markers, to classify microorganism and estimate abundance in single or mixed microorganismal populations. Features such as nonredundancy ( the pair of kmers are not identical) , are included in filters of the nucleic acid sequence data so mapping is unambiguous to only one organism ( determining that the consensus sequence does not occur in the group of background sequences ) to provide a set of taxa-specific and taxa-unique k-mers ( i.e. consensus sequence/discriminative regions ) and to estimate the abundance of the one or more taxa; thereby identifying the microorganism populations in the samples [Abstract, claim 1] Taylor WS et al. [2020: MinION sequencing of colorectal cancer tumour microbiomes—A comparison with amplicon-based and RNA-sequencing. e0233170 PloS one 15.5:16 pages; PTO 892 cited] uses Kraken2, a k-mer based algorithm, for rapid taxonomic identification of MinION and RNA-Seq data with a customised database that included gut microbe CRC-associated taxa. The k-mer based algorithm uses fragmented whole genomes as the basis of taxa classification ( decomposing each sequence within the group of target sequences into overlapping kmers ) without requiring large amounts of computational resources, and with increased speed compared to direct alignment of genomic sequences [Taylor Abstract, p11]. Bork P et al . EP2955232B1: Method for diagnosing adenomas and/or colorectal cancer (CRC) based on analyzing the gut microbiome [PTO 892 cited] teaches distinguishing CRC patients from tumor-free controls (including adenoma patients) using a consensus signature derived from metagenomic classification methodology based on LASSO penalized linear models. Ali S. [Sep 2021: Effective and scalable clustering of SARS-CoV-2 sequences. In Proceedings of the 5th international conference on big data research pp. 42-49; PTO 892 cited] teaches k-mer based feature vector generation and efficient feature selection methods for identifying major SARS CoV-2 variants and computing the importance of each amino acid position of the spike protein in identifying a given variant in terms of information gain. Positions of high variant-specific importance tend to agree with those reported by the USA’s Centers for Disease Control and Prevention (CDC). There is no active claimed step of DNA primer generation or determination of target sequence consensus/discriminative region, which is unconventional. Data ( group of target polynucleotide sequences, the pair of kmers has a distance ranging from 20 to 1000, the pair of kmers are not identical, and the pair of kmers occur more than a threshold number of the target sequences; ) are merely manipulated data to be used in the judicial exception. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination, as evidenced by the cited references teaching the combination of elements as well as the individual elements themselves, that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. With respect to the instant claims, the steps (analyzing kmer status/length/GC content and threshold percentage) and additional elements ( non-transitory computer-readable medium ) involving mathematical relationships and automated mental steps do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself ( Step 2B: No ). As such, claims 15-19 are not patent eligible. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 15-19 , are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 15 recites the term “retrieving” in “ retrieving all regions flanged by the pair of kmers in the target sequences,” which is indefinite because it is unclear what source from which retrieval occurred—a biological sample, a human, a database? Claim 15 recites the phrase “the pair of kmers occur more than a threshold number of the target sequences,” which is indefinite because it is unclear if the pair of kmers must exceed a number of target sequences OR they must exceed a number within said target sequences. Claim 15 recites the term “flanged” in “retrieving all regions flanged by the pair of kmers in the target sequences,” which is indefinite because it is unclear when ascribed its common meaning. According to Collins’ Dictionary, “flanged” is defined as “to project like , or take the form of, a flange [a projecting rim, collar, or ring on a shaft …]”. For compact prosecution, the term flanged is interpreted as “flanked” as in “if something is flanked by things, it has them on both sides of it, or sometimes on one side of it.” The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. And further, the “flanged” limitation is interpreted to have occurred outside of the four corners of the instant application without an active step. Claim 15 recites “each kmer has a length of 4 to 31 ” and “the pair of kmers has a distance ranging from 20 to 1000 ,” which is indefinite because it is unclear for the unit of distance for said ranges. For compact prosecution, the unit is interpreted as “base pairs” in polynucleotide sequences [00132].. Claim 15 recites “conserved” as in “to determine that the regions are conserved ”, which is indefinite. The term is not defined by the claim and limitations rooted in the specification [0067-0069: sequence similarity, conservation score] are needed to provide a standard for ascertaining the requisite degree or the basis of the conserved determination (per base pair, per polynucleotide, against a threshold), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 15 recites “consensus” as in “generating a consensus sequence based on the regions retrieved”, which is indefinite. The term is not defined by the claim rooted in the specification [00024,00132-00134] to provide a standard for ascertaining the requisite degree or the basis of the consensus determination (per base pair, per polynucleotide), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 16 recites the term “preferably” in “ preferably , the bacterial species is a gut microbial species, and the viral species is HIV, HCV, or Covid-19.” The term preferably renders the claim indefinite because it is a relative limitation and whether the limitation following the phrase is limiting (see MPEP § 2173.05(d)). Claim 16 recites the term “species” in “the bacterial species is a gut microbial species , and the viral species is HIV, HCV, or Covid-19.” The term species renders the claim indefinite because it is unclear when the term is ascribed its common meaning. According to Collins’ Dictionary, “species” is defined as “any of the taxonomic groups into which a genus is divided, the members of which are capable of interbreeding: often containing subspecies, varieties, or races. A species is designated in italics by the genus name followed by the specific name, for example Felis domesticus (the domestic cat)”. For compact prosecution, the term “species” is interpreted as the broad term “type.” Claim 17 recites the term “designing” in “ designing a pair of primers for amplifying the discriminative region,” which is indefinite for whether said primer pair are actually fabricated for an laboratory amplification step [0069], or merely identified for future downstream amplification/amplicon sequencing [00135]. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For compact prosecution, the term is interpreted as merely identifying primers which can be used for later downstream amplification. Claim 17 recites the term “ designing a pair of primers” in “comprising designing a pair of primers for amplifying the discriminative region ” which is indefinite as to the active steps or limiting features of the primers generation for achieving the invention. The minimally sufficient set of limitations required to design a pair of primers are not claimed. For compact prosecution, the term is interpreted as designing a pair of primers based on the determined pair of k-mers of claim 15 . Clarification is requested by amendment of claim language. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. Instant claims 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiu et al . (WO2019213624A1 [2019: Spiked primers for enrichment of pathogen nucleic acids among background of nucleic acids PTO 892 cited, herein Chiu). Note : citations from the instant application are italicized in the following section. Regarding instant claim 15, instant application recites: A computer-implemented method for identifying a discriminative region within a group of sequences, the method comprising: obtaining a plurality of sequences comprising a group of target sequences for identifying a discriminative region within the group, and a group of background sequences; decomposing each sequence within the group of target sequences into overlapping k-mers, wherein each kmer has a length of 4 to 31; identifying a pair of kmers, wherein the pair of kmers occurs at most once in each sequence within the group of target polynucleotide sequences, the pair of kmers has a distance ranging from 20 to 1000, the pair of kmers are not identical, and the pair of kmers occur more than a threshold number of the target sequences; retrieving all regions flanged by the pair of kmers in the target sequences; aligning the regions retrieved to determine that the regions are conserved; generating a consensus sequence based on the regions retrieved; determining that the consensus sequence does not occur in the group of background sequences; and retaining the consensus sequence as a discriminative region for the group of target sequences. The prior art to Chiu discloses a method of: designing spiked primer sequences that enrich sequencing reads for detecting taxa of pathogenic microorganisms (bacteria or viruses) in a sample. Primers (e.g., spiked primers) are of such a length (selecting forward and/or reverse candidate primer of 11-17 base pairs from 30 to 70 nucleotide (nt) regions at the ends of each 300 to 600 nt segment by frequency of occurrence in the set of overlapping 300 to 600 nt segments) as to preferentially amplify certain sequences associated with the first taxon and that do not amplify sequences associated with one or more other taxa of pathogens [0006] ( obtaining a plurality of sequences comprising a group of target sequences for identifying a discriminative region within the group, and a group of background sequences; i.e. using the k-mers overlapping segments to target specific genomic regions). partitioning the MSA-aligned genomes into overlapping 300 to 600 nucleotide (nt) segments with at least a 150 nt overlap ( decomposing each sequence within the group of target sequences into overlapping kmers) … selecting forward and/or reverse candidate primer sequences having lengths that are within a range of 11 bp to 17 bp from 30 to 70 nt regions at the ends of each 300 to 600 nt segment by frequency of occurrence in the set of overlapping 300 to 600 nt segments ( wherein each kmer has a length of 4 to 31 )… selecting top candidate primer sequences based upon the candidate primer sequences being shared by the most 300 to 600 nt segments and by not containing any ambiguous 300 to 600 nt segments… until the number of the remaining 300 to 600 nt segments containing a shared candidate primer sequence is below a pre-designated threshold integer value selected from 1 to 15 in order to generate a set of top candidate primer sequences; [Chiu claim 1] ( identifying a pair of kmers, wherein the pair of kmers occurs at most once in each sequence within the group of target polynucleotide sequences, the pair of kmers has a distance ranging from 20 to 1000, the pair of kmers are not identical, and the pair of kmers occur more than a threshold number of the target sequences ). applying a sequencing assay to the sample to obtain sequence reads, the sequencing assay including the set of spiked primers of claim 14 or claim 15 and random primers; and analyzing the sequence reads to determine whether the first taxon of pathogenic microorganisms and/or one or more other taxa of pathogenic microorganisms are present in the sample [reference claim 16]... wherein at least one, two, three, four, or more of the sequence regions targeted ( consensus sequence/discriminative region) by the spiked primers were identified in the set of one or more reference sequences corresponding to the taxon or taxa of pathogenic microorganisms [Chiu claim 29] ( retrieving all regions flanged by the pair of kmers in the target sequences; aligning the regions retrieved to determine that the regions are conserved; generating a consensus sequence based on the regions retrieved ). Regarding instant claim 16, instant application recites: wherein the group of target polynucleotide sequences are genomic sequences of a bacterial species or a viral species; preferably, the bacterial species is a gut microbial species, and the viral species is HIV, HCV, or Covid-19 . The prior art to Chiu teaches using one or more reference genomes are from a taxon or taxa of pathogenic bacteria, viruses , [Chiu claim 2]. Regarding instant claim 17 , instant application recites: comprising designing a pair of primers for amplifying the discriminative region. The prior art to Chiu teaches primers for detecting the presence of the particular taxon of pathogenic microorganism for amplifying a region of a gene/target sequence from the pathogen using gene-specific primers having lengths that are typically within a range of 11-17 nucleotides, and aligning a second portion of the target sequence against a second reference genome, wherein the gene-specific primers…[Chiu 00148] (amplifying the discriminative region). Regarding instant claim 18 , instant application recites: comprising filtering the kmers before the step of identifying the pair of kmers according to a criterion selected from: the kmer occurs less than or more than a threshold percentage of the target sequences; the kmer has a homopolymer, dimer or trimer of more than a threshold; and the kmer has a GC content more than or less than a threshold. The prior art to Chiu teaches generating a set of spiked primer sequences from the set of top candidate primer sequences by removing top candidate primer sequences based on desired thresholded features. (e.g. melting temperatures (Tm) greater than 2 standard deviations from the mean, self-dimerize or cross dimerize with a hybridization AG < -9 kcal/mol or lower, and/or have homopolymer repeats of greater than 5 nucleotides) [Chiu claim 1] ( the kmer occurs less than or more than a threshold percentage of the target sequences; the kmer has a homopolymer, dimer or trimer of more than a threshold; and the kmer has a GC content more than or less than a threshold ). Regarding instant claim 19 , instant application recites: A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to perform the method of claim 15. The prior art to Chiu teaches using software code stored as a series of instructions or commands on a computer readable medium for storage and/or transmission, suitable media include random access memory (RAM)… [Chiu 00159]. Relevant Prior Art Abram K [Jan 2021: Mash-based analyses of Escherichia coli genomes reveal 14 distinct phylogroups. Communications Biology , 4 (1), 117: 12 pages; doi.org/10.1038/s42003-020-01626-5; PTO 892 cited] analyzes of E. coli . whole-genome sequences (both whole genome and Sequence Read Archive) for representative sequences for their associated phylogroup, allowing pathogenic strain identification of the same genetic lineage across different temporal and geographical outbreaks based on k-mer size of 21, distance-based similarity in nucleotide content between genomes [Abram p. 1]. GC content awareness is also considered [Abram p10]. O’Hara et al. US12,176,071: Systems and methods for ultra-fast identification and abundance estimates of microorganisms using a kmer-depth based approach and privacy-preserving protocols [PTO 892 cited] teaches using a k-mer based approach, with a reference k-mer library database of taxa specific markers and taxa unique markers, to classify microorganism and estimate abundance in single or mixed microorganismal populations. Features such as nonredundancy is included in filters of the nucleic acid sequence data so mapping is unambiguous to only one organism to provide a set of taxa-specific and taxa-unique k-mers and to estimate the abundance of the one or more taxa; thereby identifying the microorganism populations in the samples [Abstract, claim 1] Conclusion No claims are allowed. E-mail Communications Authorization Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439 . Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination. Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03. Inquiries Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vy Rossi, whose telephone number is (703) 756-4649. The examiner can normally be reached on Monday-Friday from 8:30AM to 5:30PM ET. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571) 272-2249. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. /VR/ Examiner Art Unit 1685 /MARY K ZEMAN/Primary Examiner, Art Unit 1686 Application/Control Number: 17/930,460 Page 2 Art Unit: 1685 Application/Control Number: 17/930,460 Page 3 Art Unit: 1685 Application/Control Number: 17/930,460 Page 4 Art Unit: 1685 Application/Control Number: 17/930,460 Page 5 Art Unit: 1685 Application/Control Number: 17/930,460 Page 6 Art Unit: 1685 Application/Control Number: 17/930,460 Page 7 Art Unit: 1685 Application/Control Number: 17/930,460 Page 8 Art Unit: 1685 Application/Control Number: 17/930,460 Page 9 Art Unit: 1685 Application/Control Number: 17/930,460 Page 10 Art Unit: 1685 Application/Control Number: 17/930,460 Page 11 Art Unit: 1685 Application/Control Number: 17/930,460 Page 12 Art Unit: 1685 Application/Control Number: 17/930,460 Page 13 Art Unit: 1685 Application/Control Number: 17/930,460 Page 14 Art Unit: 1685 Application/Control Number: 17/930,460 Page 15 Art Unit: 1685 Application/Control Number: 17/930,460 Page 16 Art Unit: 1685 Application/Control Number: 17/930,460 Page 17 Art Unit: 1685 Application/Control Number: 17/930,460 Page 18 Art Unit: 1685 Application/Control Number: 17/930,460 Page 19 Art Unit: 1685 Application/Control Number: 17/930,460 Page 20 Art Unit: 1685
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Prosecution Timeline

Sep 08, 2022
Application Filed
Mar 30, 2026
Non-Final Rejection — §101, §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
33%
Grant Probability
80%
With Interview (+46.6%)
4y 7m
Median Time to Grant
Low
PTA Risk
Based on 39 resolved cases by this examiner. Grant probability derived from career allow rate.

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