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 .
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence submitted 12/30/2025. In the paper of 12/30/2025, Applicant perfected the claim to foreign priority by submitting English translation of foreign document(s) KR 10-2021-0032317 and KR 10-2022-0029865 along with statement that the translation of the certified copy is accurate. The effective filing date of the instant application is 03/11/2021.
In the paper of 12/30/2025, Applicant amended claims 1, 9 and 11 and newly canceled claims 2-4 and 7 so that claims 1, 5-6 and 8-12 are pending. Claim 11 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Response to Arguments
Moot and/or Withdrawn Rejection(s)
The rejections of claims 2 and 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reasons as stated in paragraphs 8-10 in the Non-Final Office action mailed on 10/14/2025 are moot based on the cancellation of these claims.
The rejections of claims 1, 5-6 and 8-10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reasons as stated in paragraphs 8-10 in the Non-Final Office action mailed on 10/14/2025 are withdrawn based on the amendments made to claims 1 and 9.
The rejection of claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is moot based on the cancellation of this claim.
The rejections of claims 2 and 4 under 35 U.S.C. 101 are moot based on the cancellation of these claims.
The rejections of claims 2 and 4 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) are moot based on the cancellation of these claims.
Maintained Rejection(s)
The rejection of claims 1, 5-6 and 8-10 under 35 U.S.C. 101 is maintained with minor amendments to the rejection as necessitated by claim amendments, 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 12/30/2025 have been fully considered but they are not persuasive because of the following.
Applicant argues that all SEQ ID NOs: 1-78 are artificial, engineered, and non-naturally occurring sequences, designed specifically for the Applicant's targeted detection assay and do not appear in nature in their claimed form (see Remarks, 12/30/2025, section entitled “Claim Rejections- 35 USC 101”, last para of pg 6).
Applicant’s arguments are not found to be 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 of SEQ ID NO: 7 or SEQ ID NO: 8, and a non-specified nucleotide sequence. 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. 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.
The instant claims do not recite any additional elements that integrate the judicial 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. “non-naturally occurring features” e.g. fluorophores, dyes etc.).
The rejection under 35 U.S.C. 101 for being directed to ineligible subject matter are maintained in view of the above statements.
Regarding the rejection under 35 under 35 U.S.C. 103, Applicant argues neither Guk nor GenBank teach any sequence corresponding to SEQ ID NOs: 7-10 (see Remarks of 12/30/2025, pg 7, all text of section entitled “Claim Rejections- 35 USC 103”).
Applicant argues that An, SantaLucia, and Polansky concern only general principles of primer design, not the specific sequences of SEQ ID NOs: 7-10, nor any motivation to select these particular sequences among innumerable alternatives. These secondary references do not remedy the deficiencies of Guk or GenBank (see Remarks of 12/30/2025, last two paragraphs of pg 7).
Applicant’s arguments are not found to be persuasive as it has been held that the test for obviousness is not whether the features of one reference may be bodily incorporated into the other to produce the claimed subject matter but simply what the combination of references makes obvious to one of ordinary skill in the pertinent art. (see In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The instant primer pair comprising one of SEQ ID NO: 7 or SEQ ID NO: 8 is not inventive 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 the instant SEQ ID NO: 7, or 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 one of SEQ ID NO: 7, or SEQ ID NO:8; or to a kit or a composition, or a sequencing panel comprising the at least one primer pair 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 does 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
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455
568
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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, or 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/or 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, or 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/or SEQ ID NO: 8 or SEQ ID NO: 9 and/or 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/or 8; and SEQ ID NO: 9 and/or 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.
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.
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.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681