Prosecution Insights
Last updated: October 04, 2026
Application No. 17/692,236

PRIMER SET FOR DETECTING FOOD POISONING BACTERIA BY USING NEXT-GENERATION SEQUENCING METHOD AND METHOD FOR DETECTING FOOD POISONING BACTERIA BY USING THE PRIMER SET

Non-Final OA §101§103
Filed
Mar 11, 2022
Priority
Mar 11, 2021 — RE 10-2021-0032317 +1 more
Examiner
OYEYEMI, OLAYINKA A
Art Unit
1681
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Korean Ministry Of Food And Drug Safety
OA Round
3 (Non-Final)
60%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
281 granted / 465 resolved
At TC average
Strong +46% interview lift
Without
With
+46.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
17 currently pending
Career history
488
Total Applications
across all art units

Statute-Specific Performance

§101
10.8%
-29.2% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
11.0%
-29.0% vs TC avg
§112
33.0%
-7.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 465 resolved cases

Office Action

§101 §103
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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/01/2026 has been entered. Status of the Applications, Amendments and/or Claims This action is written in response to applicant's correspondence submitted 09/01/2026. In the paper of 09/01/2026, Applicant amended claim 1 and submitted arguments in the Remarks of 09/01/2026. Claims 1, 5-6 and 8-12 are pending. Claim 11 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b). Election was made without traverse in the reply filed on 07/02/2025. Response to Arguments The rejection of claims 1, 5-6 and 8-10 under 35 U.S.C. 101 is maintained because the claimed invention is still directed to a judicial exception without significantly more. The rejection of claims 1, 5-6, 8-10 and 12 under 35 U.S.C. 103 as being unpatentable over Guk et al. (Nov. 19, 2019, Microorganisms, 7(579): pp 1-16) as evidenced by Guk et al. supplementary pages, pp. 1-.11) in view of Genbank Accession no. CP011015.1 (submitted March 09, 2015), An et al. (US2003/0050470), SantaLucia et al. (2007, HumanaPress: pp 3-33) and Polansky (US2004/0023207) is maintained with minor amendments to the rejection as necessitated by claim amendments. Argument(s) Applicant's arguments filed 09/01/2026 have been fully considered but they are not persuasive because of the following. Applicant argues that claim 1 is directed to primer pairs comprising specifically selected and arranged set of synthetic primers configured for a particular technological application-generation of amplification products suitable for high-throughput sequencing, that the claimed primer set, considered as a whole, is an engineered combination of selected oligonucleotide primers having a defined structural arrangement and functional relationship and that the claimed combination does not occur in nature as such and is specifically configured to generate amplification products suitable for high-throughput sequencing. Thus, the claims are directed to an engineered molecular tool having a specific practical application, rather than to a naturally occurring nucleic acid sequence (Remarks, 09/01/2026, pg 6, 2nd para to 5th para of section entitled “Claim Rejections-35 USC § 101”). Applicant’s arguments are not persuasive as Applicant’s claims are directed to a pair of nucleotide sequences and to composition(s) thereof (e.g. kits, panel) i.e. composition of matter that are not markedly different from naturally occurring counterpart, thus not significantly more than judicial exception based on the guidance from MPEP 2106.04(b)(i) and in MPEP 2016.04(b)(II). The instant primer pair comprise a nucleotide sequence comprising SEQ ID NO: 7 and a nucleotide sequence comprising SEQ ID NO: 8. These sequences are identified as isolated nucleic acids having no structural or functional differences from naturally occurring nucleic acids and an example of patent-ineligible natural product. According to M.P.E.P. 2106.04(b) section I and M.P.E.P. 2106.04(b) section II, the courts have identified the following concepts and products as examples of laws of nature or natural phenomena: (i) isolated DNA, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013);…. (viii) single-stranded DNA fragments known as "primers", University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014). The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). According to M.P.E.P. 2106.04(b) section II, it makes no difference that the identified gene sequences (i.e. the instant one or more primer pairs as claimed in claim 1) are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. The instant SEQ ID NO: 7 is 100% identical to and indistinguishable from nucleotides 341,331 - 341,351 of GenBank Accession No. CP011015.1, a naturally occurring sequence. The instant SEQ ID NO: 8 is 100% identical to and indistinguishable from nucleotides 341,533 -341,513 of GenBank Accession No. CP011015.1, a naturally occurring sequence. Accordingly, a primer comprising SEQ ID NO: 7 and a primer comprising SEQ ID NO: 8 do not have markedly different characteristics from nucleotide sequences derived from the oligonucleotide having the GenBank Accession No. CP011015.1. Furthermore, concerning composition(s) that comprise a mixture of two or more primer pairs as claimed in claim 1, these composition(s) are not patent-eligible, as each primer within the composition does not have a markedly different property than its natural counterpart. Regarding Applicant’s argument, that claim 1 is directed to primers configured to generate amplification products suitable for high-throughput sequencing, this argument is not persuasive as each primer within the claimed composition(s) do not have a markedly different property than its natural counterpart AND with respect to the manner in which a claimed composition/product is intended to be employed, this intended use does not differentiate the claimed composition/product from a prior art composition/product satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Finally, the rejection under 35 U.S.C. 101 for the claims being directed to ineligible subject matter are maintained in view of the above statements and also because the instant claims do not recite any additional elements that integrate the judicial exception (i.e. natural product exception) into a practical application and do not recite any additional elements so that the claim amounts to significantly more than the judicial exception (e.g. a composition/mixture or kits comprising nucleotide sequences comprising “non-naturally occurring features” e.g. fluorophores, dyes etc.). Regarding the rejection under 35 under 35 U.S.C. 103, Applicant argues that the cited combination fails to teach or suggest the claimed primer set and provides no sufficient reason for a person of ordinary skill in the art to arrive at the claimed invention (Remarks, 09/01/2026, pg 7, 1st para). Applicant argues that Guk do not teach or suggest the claimed primer set which are configured to amplify a target sequence to produce an amplicon having a size suitable for high-throughput sequencing (Remarks, 09/01/2026, pg 7, 2nd para and 4th para) and that Examples 1-3 and Table 4 provides the instant primer set which are designed for amplicon-based high-throughput sequencing, wherein shorter amplification products are produced for suitable sequencing performance in multiplex assays (Remarks, 09/01/2026, pg 7, 5th para). In contrast, Applicant state that Guk teach PCR primers directed to the flhB gene which generates a PCR product exceeding approximately 300 base pairs for detecting Campylobacter coli (Remarks, 09/01/2026, pg 7, 2nd para). Applicant argues that Guk neither teaches nor suggests designing its disclosed primer pairs for amplicon-based high-throughput sequencing and that Guk also does not provide a reason to modify its primer sequences so as to obtain the particular primer combinations recited in Claim 1 and the corresponding amplification products suitable for high-throughput sequencing (Remarks, 09/01/2026, pg 7, 6th para). Applicant argues that An, SantaLucia, and Polansky do not remedy the deficiencies of Guk and concern only general principles of primer design, not the claimed sequences of claim 1, nor do these references teach or suggest any motivation to select the particular sequences recited by claim 1 among innumerable alternatives (Remarks, 09/01/2026, pg 7, last para and pg 8, paragraphs 1-3). Applicant’s arguments are not found to be persuasive because of the following: (1) Claim 1 is currently directed to a primer set comprising at least one primer pair, the primer pair is a forward primer comprising SEQ ID NO: 7 and a reverse primer comprising SEQ ID NO: 8. Accordingly, the claimed primer pair encompasses producing amplicons that are sized larger than the amplicon produced by use of a forward primer consisting SEQ ID NO: 7 and a reverse primer consisting SEQ ID NO: 8 under amplification conditions. The instant claims do not recite any limitations directed towards the primer pairs of claim 1 for producing short amplicons sized ≤ 300 bp as Applicant have argued. Accordingly, the instant primer pairs as claimed in claim 1 are not distinct or innovative over the primers of Guk as the limitations on which the Applicant relies are not stated in the claims. (2) Furthermore, Applicant's argument that the instant primer pairs are non-obvious as they are used for a different purpose (i.e. for generating amplicons size ≤ 300 bp suitable for high throughput-sequencing) than the primer pair of Guk (for generating a 203 bp amplicon consisting nucleotides 341,331 - 341,533 of GenBank Accession No. CP011015.1) would not alter the conclusion that the instant primer pair(s) are prima facie obvious over the primer pair taught by Guk in view of other cited references. First, it has been held that a recitation with respect to the manner in which a claimed product/composition is intended to be employed does not differentiate the claimed product/composition from a prior art product/composition satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). (2) Applicant’s argument fails to make a convincing case for why the 203 bp flhB amplicon generated with the primer pair of Guk et al. would not be suitable for high throughput-sequencing. The examiner maintains the conclusion that the instant primer pair comprising SEQ ID NO: 7 and SEQ ID NO: 8 are prima facie obvious in view of the teachings of Guk et al. (Nov. 19, 2019, Microorganisms, 7(579): pp 1-16: previously cited) as evidenced by Guk et al. supplementary pages, pp. 1-11), Genbank Accession no. CP011015.1 (submitted March 09, 2015: previously cited), An et al. (US2003/0050470: previously cited), SantaLucia et al. (2007, HumanaPress: pp 3-33: previously cited) and Polansky (US2004/0023207: previously cited) since Guk et al. already it teach a matter of routine practice in the art to design and use in a polymerase chain reaction method, flhB specific primers to identify Campylobacter nucleic acids of a sample before the effective filing date of the invention. It is within the skill of the ordinary skilled artisan to derive other functionally equivalent alternative flhB primers such as primers comprising the instant SEQ ID NO: 7 and SEQ ID NO: 8 from the known GenBank sequence CP011015.1 using known prior art primer design protocol such as An and SantaMaria and would have done so with a reasonable expectation of success, and would have been motivated to assemble the(se) functionally equivalent alternative flhB primers into a kit or composition or sequencing panel for additional convenience and reproducible access to utilize the(se) in method(s) of choice by the ordinary skilled artisan. Applicant is welcomed to submit evidence of unexpected results for the instant primer pairs that would be weighed against the prior art in the consideration of non-obviousness. 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, 5-6 and 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The analysis The eligibility of claims 1, 5-6 and 8-10 are considered in light of the revised Patent Subject Matter Eligibility Guidance (revised June 2020), the Berkheimer Memo and M.P.E.P section 2103- 2106.07 (c). The eligibility analysis requires one to address the following questions: (i) Step 1 – Is the claim directed to one of the four statutory categories (i.e., process, machine, manufacture or composition of matter); (ii) Step 2A – Is the claim directed to a judicial exception (i.e., a natural phenomenon, law of nature or abstract idea); and (iii) Step 2B – does the claim recite additional elements that amount to significantly more than the judicial exception. In addition, Step 2A is a two-prong inquiry, with Prong One asking whether the claims recite a judicial exception (i.e., an abstract idea, natural phenomenon or law of nature) and Prong Two asking whether the claims recite additional elements that integrate the judicial exception into a practical application. Step 1 Claims 1, 5-6 and 8-10 are construed as being drawn to a primer set comprising at least one primer pair for detecting Campylobacter coli, said primer pair comprising SEQ ID NO: 7 and SEQ ID NO:8; or to a kit or a composition, or a sequencing panel comprising the at least one primer pair recited by claim 1 thereof, Accordingly, claims 1, 5-6 and 8-10 are directed to one of the four statutory categories (i.e. composition of matter/ product of nature). Step 2A With respect to Step 2A, claims 1, 5-6 and 8-10 are directed to a judicial exception since claims 1, 5-6 and 8-10 encompass(es) nucleotide sequence(s) of Campylobacter coli (thereby, reading over naturally occurring Campylobacter coli sequence(s)). MPEP 2106.04(b)(i) identifies isolated nucleic acids having no structural or functional differences from naturally occurring nucleic acids as an example of a patent-ineligible natural product. In addition, as discussed in MPEP 2016.04(b)(II), “[P]roduct of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” See Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244. Claims 1, 5-6 and 8-10 clearly recite a judicial exception since the primer of a 4th primer pair comprising of the instant SEQ ID NO: 7 is 100% identical to and indistinguishable from nucleotides 341,331 - 341,351 of GenBank Accession No. CP011015.1, a naturally occurring sequence. Claims 1, 5-6 and 8-10 clearly recite a judicial exception since a 4th primer pair comprising the instant SEQ ID NO: 8 is 100% identical to and indistinguishable from nucleotides 341,533 -341,513 of GenBank Accession No. CP011015.1, a naturally occurring sequence. Claim 1 clearly recite a judicial exception since the primer comprising the instant SEQ ID NO: 9 is 100% identical to and indistinguishable from nucleotides 279,695 – 279,715 of GenBank Accession No. CP011015.1, a naturally occurring sequence and since the primer comprising the instant SEQ ID NO: 10 is 100% identical to and indistinguishable from nucleotides 279,902 – 279,882 of GenBank Accession No. CP011015.1, a naturally occurring sequence. Furthermore, claims 1, 5-6 and 8-10 also do not recite any additional elements that integrate the judicial exception into a practical application. One or more of the recited elements of claims 1, 5-6 and 8-10 are naturally occurring products and these claims do not recite additional elements (“non-naturally occurring features” e.g. fluorophores, dyes etc.) that integrate the judicial exception into a practical application. Step 2B With respect to Step 2B, claims 1, 5-6 and 8-10 do not recite any additional elements so that the claim amounts to significantly more than the judicial exception. For example, claims 1, 5-6 and 8-10 do not require kits/packages that comprise nucleotide sequence(s) that include a non-naturally occurring label or non-naturally occurring nucleotides, nor do the kit comprise elements(s) that are non-naturally occurring and/or composition(s) that have characteristics not possessed by naturally occurring products. In view of the foregoing, claims 1, 5-6 and 8-10 are rejected under 35 U.S.C. 101 for being directed to ineligible subject matter. Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 5-6, 8-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Guk et al. (Nov. 19, 2019, Microorganisms, 7(579): pp 1-16: previously cited) as evidenced by Guk et al. supplementary pages, pp. 1-11: previously cited) in view of Genbank Accession no. CP011015.1 (submitted March 09, 2015: previously cited), An et al. (US2003/0050470: previously cited), SantaLucia et al. (2007, HumanaPress: pp 3-33: previously cited) and Polansky (US2004/0023207: previously cited). Regarding claims 1, 5-6 and 8-10, Guk et al. teach a primer set/composition for detecting Campylobacter coli comprising a forward primer consisting 5’-TGGCAGGCGAAGATCAAGAA-‘3 and a reverse primer consisting 5’-GCCAAGTAAGCTGTGCAACC-‘3 (see Supplementary pg 1, for disclosure in Table S1, Table S1 is further reproduced below). Regarding claim 12, Guk et al. teach a PCR method for detecting the foodborne pathogen, Campylobacter coli present in duck carcass/meat (see pg 2, section 2.1 and pg 3, section entitled “Virulence genes of C. coli isolates” and Supplementary pg 1, Table S1, reproduced below). Supplementary Table S1: Guk et al.’s primers (reproduced from pg 1, Supplementary content) PNG media_image1.png 455 568 media_image1.png Greyscale Omitted from Guk et al. (claims 1, 9-10, 12) Regarding claims 1 and 12, Guk et al. do not teach a primer set comprising of at least one primer pair, wherein at least one primer of the primer pair comprise a primer consisting of SEQ ID NO: 7, and a primer consisting of SEQ ID NO: 8, or wherein the primer set comprise at least the primer pair consisting of SEQ ID NOS: 7-8 and SEQ ID NOS: 9-10. Regarding claim 12, Guk et al. do not teach providing the primer set comprising of at least one primer pair, wherein at least one primer of the primer pair comprise a primer consisting of SEQ ID NO: 7, and a primer consisting of SEQ ID NO: 8, or wherein the primer set comprise at least one primer pair consisting of SEQ ID NOS: 7-8 and/or SEQ ID NOS: 9-10, and performing an amplification reaction using a sample and the primer set. Regarding claims 9-10, Guk et al. do not teach a next generation sequencing panel, or a kit. GenBank (2015) GenBank teach an oligonucleotide having the Accession No. CP011015 that is 100% identical to and indistinguishable from the instant SEQ ID NO: 7 at nucleotides 341,331 – 341,351, the instant SEQ ID NO: 8 at nucleotides 341,533 – 341,513; and 100% identical to and indistinguishable from the instant SEQ ID NO: 9 at nucleotides 279,695 – 279,715 and 100% identical to and indistinguishable from the instant SEQ ID NO: 10 at nucleotides 279,902 – 279,882. An et al. (2003) Regarding primer and probe design, An et al. teach at paragraphs [0065]-[0067]: "Various probes and primers can be designed around the disclosed nucleotide sequences. Primers may be of any length but, typically, are 10-20 bases in length. By assigning numeric values to a sequence, for example, the first residue is 1, the second residue is 2, etc., an algorithm defining all primers can be proposed: n to n+y where n is an integer from 1 to the last number of the sequence and y is the length of the primer minus one (9 to 19), where n+y does not exceed the last number of the sequence. Thus, for a 10-mer, the probes correspond to bases 1 to 10, 2 to 11, 3 to 12 . . . and so on. For a 15-mer, the probes correspond to bases 1 to 15, 2 to 16, 3 to 17 . . . and so on. For a 20-mer, the probes correspond to bases 1 to 20, 2 to 21, 3 to 22 . . . and so on." Therefore, An et al. not only taught designing primers of any length based on a known sequence, but also taught an algorithm for defining all possible primers of a given length based on a known sequence. In this respect, An et al. taught that all possible subsequences of a known sequence could be considered as a primer for that sequence. While An et al. was discussing in particular sequences having to do with prostate, bladder and breast cancer (see Abstract), one of ordinary skill in the art would have recognized that the principles of designing primers and probes based on a disclosed nucleotide sequence would have applied to any nucleotide sequence under study. SantaLucia et al. (2007) SantaLucia et al. teach on page 14, “over the last 10 years (1996–2006), I have informally polled scientists who are experts in PCR and asked: “What percentage of the time does a casually designed PCR reaction ‘work’ without any experimental optimization?” In this context, “work” means that the desired amplification product is made in good yield with a minimum of artifact products such as primer dimers, wrong amplicons, or inefficient amplification. By “casually designed,” I mean that typical software tools are used by an experienced molecular biologist. The consensus answer is 70–75%. If one allows for optimization of the annealing temperature in the thermocycling protocol (e.g., by using temperature gradient optimization), magnesium concentration optimization, and primer concentration optimization, then the consensus percentage increases to 90–95%." Thus, SantaLucia et al. teach primers casually designed to a target sequence have a reasonable expectation of success at hybridizing, amplifying and detecting a target sequence. Polansky (US2004/0023207) (claim 10) Polansky disclosed (paragraph [0919]): “Well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures.” Regarding claim 9, neither Guk et al., GenBank CP011015, An et al., SantaLucia, An et al. or Polansky teach a next generation sequencing panel comprising the instant primer set. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide functionally equivalent alternative primers to those taught by Guk et al. so as to enable the detection of Campylobacter coli at (an) alternative nucleotide sequence(s) than those taught by Guk et al., with a reasonable expectation of success. The ordinary skilled artisan would have recognized that the sequence(s) derived from the GenBank oligonucleotide having the Accession No. CP011015 correspond to homologs that are beneficial to use to amplify and/or detect the presence of Campylobacter coli in a test sample and would have been further motivated to follow guidance provided by An et al. and SantaLucia et al. for making and optimizing the primers and/ probes comprising SEQ ID NO: 7 and SEQ ID NO: 8 or SEQ ID NO: 9 and SEQ ID NO: 10, any nucleotide sequence derived from Genbank Accession No. CP011015, which are suitable for detecting the presence of Camplylobacter coli in the sample. It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to incorporate the materials for detecting Campylobacter coli as taught by the combined disclosures of Guk et al., GenBank Accession No. CP011015, An et al., Santa Lucia into a “kit” to obtain the advantages of kits espoused by Polansky. It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application, wanting to validate the presence of Campylobacter coli, by sequencing amplicons, to provide a next generation sequencing panel that comprises probes for hybridizing SEQ ID NO: 7 and 8; and SEQ ID NO: 9 and 10, thereby use the panel to validate the presence of Campylobacter coli. In view of the combined teachings and suggestions of all of the cited prior art references, the instant claims 1, 5-6, 8-10 and 12 are prima facie obvious. Conclusion No claims are currently allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST. 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, GARY Benzion can be reached at 571-272-0782. 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. OLAYINKA A. OYEYEMI Examiner Art Unit 1681 /OLAYINKA A OYEYEMI/Examiner, Art Unit 1681 /GARY BENZION/Supervisory Patent Examiner, Art Unit 1681
Read full office action

Prosecution Timeline

Mar 11, 2022
Application Filed
Oct 14, 2025
Non-Final Rejection mailed — §101, §103
Dec 30, 2025
Response Filed
Apr 01, 2026
Final Rejection mailed — §101, §103
Sep 01, 2026
Request for Continued Examination
Sep 02, 2026
Response after Non-Final Action
Sep 21, 2026
Non-Final Rejection mailed — §101, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
60%
Grant Probability
99%
With Interview (+46.5%)
3y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 465 resolved cases by this examiner. Grant probability derived from career allowance rate.

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