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 Application
The Amendment filed June 5, 2026 is acknowledged.
Claims 1-5, 7-11, 13-17, 19-23, 25-27, 32-33 and 35 were pending. Claims 1, 20-22, 25 and new claims 40-49 are being examined on the merits. Claims 2-5, 7-11, 13-17, 19, 26-27, 32-33 and 35 remain withdrawn. Claim 23 is canceled.
Response to Arguments
Applicant’s arguments filed June 5, 2026 have been fully considered.
The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the specification:
Objection to the Specification – missing sequence identifiers
The following rejections are MODIFIED in view of Applicant’s arguments and amendments to the claims:
Rejection of claims 1, 20-21 and 25 under 35 USC § 101
Prior art rejections
Double patenting rejections
Response to arguments regarding 35 USC § 101 rejections
Applicant argues that the subject matter eligibility rejections should be withdrawn because claim 23 was not included in the previous rejections and claim 1 is instantly amended to incorporate the subject matter of (now canceled) claim 23 (Remarks, p. 10).
The Examiner has re-considered the rejection and determined that claim 23 should have been included in the prior rejection. As discussed further in the modified rejection below, the instant specification teaches that a “label” can be either a naturally-occurring molecule (e.g., a mass tag) or a non-naturally occurring molecule (e.g., a fluorophore). Consequently, to the extent that the claims encompass embodiments comprising labels that are naturally occurring molecules, the rejection is maintained. It is also noted that in claim 1, the probe is optional (“one or more primers and/or one or more probes”). Further, each of the probes in claim 25 requires at least one fluorophore label, however, claim 25 does not explicitly require the presence of the probe in the claim 1 kit either. Thus, claim 25 is still included in the rejection.
The rejections are modified in view of this issue.
Response to arguments regarding prior art rejections
Applicant argues that the prior art rejections should be withdrawn because the elected species of instant claim 1 requires selecting ten specific primers and six specific probes targeting different OXA gene families. Given that each of the primers and probes comprises hundreds of possible sequences, this creates an astronomical number of possible combinations of primers and probes for the five different OXA genes, and the ordinary artisan would not be able to select “all five different OXA gene targets recited in claim 1(F)” (Remarks, pp. 10-12).
The Examiner disagrees. Instant claim 1 recites “one or more primers and/or one or more probes for the identification of one or more genes”. Thus, the elected species of claim 1 at least comprises embodiments directed to a single primer/probe directed to a single OXA gene. Consequently, the ordinary artisan would have not to select a combination of primers, probes and genes from an astronomical number of possible combinations. Further, the gene targets are known in the art, and the probe sequences are constrained by the corresponding primer sequences (i.e., the probe has to hybridize to a region of the target that is in between the forward and reverse primer target binding sequences). Thus, while experimentation and optimization is certainly required to arrive at the claimed primer and probe sequences, it is not clear that the ordinary artisan would be likely unsuccessful in doing so.
These arguments are not persuasive. The rejections are modified in view of the instant claim amendments.
Response to arguments regarding double patenting rejections
Applicant notes that the Non-Final Office Action mailed December 5, 2025 referred to US Serial No. 19/485,294, which apparently included a typographical error (Remarks, p. 12).
The Examiner notes that the reference to US Serial No. 19/485,294 is a typographical error and apologizes for the inadvertent misdirection. It has been corrected below to refer to 19/485,594.
Applicant argues that the double patenting rejections should be withdrawn in view of MPEP 804(I)(B)(1)(B)(i) because the instant application has an earlier filing date than the ‘594 application (Remarks, p. 13).
Since the provisional nonstatutory double patenting rejection is not currently the only remaining rejection in the case, the rejections are maintained.
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, 20-21, 25, 40 and 48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Eligibility is considered in light of MPEP 2106 III, which incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 17, 2019 (84 Fed. Reg. 50) and clarified in the October 2019 Update.
As can be seen in the MPEP 2106 III Figure, 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, as can be seen in the MPEP 2106.04 II Figure, 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.
In this case, as to Step 1, claims 1, 20-21, 25, 40 and 48 are directed to one of the four statutory categories since they are drawn to a composition of matter.
The analysis cannot be streamlined, so the claims are considered with respect to Step 2A.
With respect to Prong One of Step 2A, claims 1, 20-21, 25, 40 and 48 recite a judicial exception. Specifically, the primers/probes are a product of nature (i.e., a natural phenomenon). The claims require primers/probes that each specifically bind to a particular OXA or rRNA gene. It is not clear that these primers exist in nature, but these oligonucleotides, are, nevertheless, judicial exceptions because they are derived from naturally occurring nucleic acids (see citations in conjunction with the prior art rejections below) and possess no structural or functional differences relative to their naturally occurring counterpart. For example, the oligonucleotides are not required to include a label or non-naturally occurring nucleotides, nor do they have functions not possessed by naturally occurring nucleic acids. As well, MPEP 2164.04(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. In this case, the claimed oligonucleotides have no functional differences relative to their naturally occurring counterparts since both the claimed and naturally occurring molecules hybridize to complementary nucleic acids. Further, regarding the recitation of a “label” in claims 1 and 40, it is noted that the specification (para. 86) recites a number of embodiments of labels, including some that are not naturally occurring (e.g., a fluorophore, a quencher), and some that at least comprise naturally occurring molecules (e.g., a barcode, a mass tag). Thus, to the extent that “label” in claims 1 and 40 is directed to embodiments encompassing a naturally occurring molecule, these embodiments are also directed to judicial exceptions.
In view of the foregoing, claims 1, 20-21, 25, 40 and 48 clearly recite a judicial exception. With respect to Prong Two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application for the following reason. In particular, the claims do not require any components other than the judicial exception. In addition, to the extent that the term “kit” in the preamble is construed to require something additional, such as assembling the various oligonucleotides into container(s), which is also explicitly recited in claim 48, this also constitutes insignificant extra-solution activity as described in the 2019 PEG and MPEP 2106.05(g).
Thus, the answer to step 2A is “Yes, the claims are directed to a judicial exception,” and the analysis moves to Step 2B, which asks if the additional elements in the claim amount to significantly more than the judicial exception.
In this case, claims 1, 20-21, 25, 40 and 48 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1, 20-21, 40 and 48 need not have any components other than the recited oligonucleotides. In addition, assembling nucleotides into kits was routinely taught in the art prior to the effective filing date of the claimed invention (e.g., see Torres (WO 2017/218789 A1; cited below in conjunction with the prior art rejections): paras. 11, 34). Therefore, an additional element of a kit is not non-routine or unconventional.
In view of the foregoing, claims 1, 20-21, 25, 40 and 48 are rejected under 35 U.S.C. 101 as being drawn to a judicial exception without significantly more.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 44 and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 44 and 46 contain trademark/trade names for various fluorescent reporter and quencher molecules. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the source of fluorescent reporter and quencher molecules and, accordingly, the identification/description is indefinite. Specifically, the trademarks are: FAM, HEX, TYE665, Iowa Black, Black Hole Quencher, BHQ [X], ATTO [X], BBQ-650.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 recites various SEQ ID NOs corresponding to labeled versions of the claim 1
probes. Since the probes in claim 1 are optional, claim 1 encompasses embodiments that comprise probes and embodiments that do not comprise probes. While claim 25 recites a further limitation of the probes, it also does not require that the probes are present in the kit. Thus, to the extent that claim 25 is directed to embodiments to that do not require probes, claim 25 does not further limit claim 1, and is in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres1 (WO 2017/218789 A1) in view of GenBank Accession No. MF594724.12 (Acinetobacter pittii strain 1-1175 OXA-143 family carbapenem-hydrolyzing class D beta-lactamase-like protein (blaOXA) gene, partial cds, 2018) and An3 (US 2003/0050470).
Regarding independent claim 1 and dependent claim 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 322-323 and 324 (labeled)/364 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. MF594724.1: 140-165, 382-406 (reverse complement) and 312-336, respectively.
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. MF594724.1 (Acinetobacter pittii strain 1-1175 OXA-143 family carbapenem-hydrolyzing class D beta-lactamase-like protein (blaOXA) gene, partial cds, 2018) and An (US 2003/0050470), as applied to claim 1 above, and further in view of GenBank Accession No. JN358191.14 (Uncultured bacterium clone 4_D_061373_0176_0934 16S ribosomal RNA gene, partial sequence, 2011).
Regarding dependent claim 21, Torres teaches that the kit further comprises instant SEQ
ID NOs: 79-80, 76-77 and 370 (Torres SEQ ID NOs: 79-80, 76-77 and 30, respectively). Torres also teaches detecting rRNA as a control (para. 59).
Regarding instant SEQ ID NOs: 340 (labeled)/369 (unlabeled), these sequences correspond with 100% homology to nucleotides 24-47 of GenBank Accession No. JN358191.1, which corresponds to bacterial 16S rRNA.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to further modify the modified Torres primer/probe kits, to include a probe that detects rRNA. Torres teaches detecting rRNA as a control gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels, and to incorporate appropriate control reagents for a particular assay, using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Claims 1, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. MG254523.15 (Acinetobacter baumannii strain KK-AB:12 class D beta-lactamase OXA-24 (blaOXA gene), blaOXA-24 allele, partial cds, 2018) and An (US 2003/0050470).
Regarding independent claim 1 and dependent claim 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 328-329 and 330 (labeled)/365 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. MG254523.1: 158-183, 390-411 (reverse complement) and 329-357, respectively.
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. MG254523.1 (Acinetobacter baumannii strain KK-AB:12 class D beta-lactamase OXA-24 (blaOXA gene), blaOXA-24 allele, partial cds, 2018) and An (US 2003/0050470), as applied to claim 1 above, and further in view of GenBank Accession No. JN358191.1 (Uncultured bacterium clone 4_D_061373_0176_0934 16S ribosomal RNA gene, partial sequence, 2011).
Regarding dependent claim 21, Torres teaches that the kit further comprises instant SEQ
ID NOs: 79-80, 76-77 and 370 (Torres SEQ ID NOs: 79-80, 76-77 and 30, respectively). Torres also teaches detecting rRNA as a control (para. 59).
Regarding instant SEQ ID NOs: 340 (labeled)/369 (unlabeled), these sequences correspond with 100% homology to nucleotides 24-47 of GenBank Accession No. JN358191.1, which corresponds to bacterial 16S rRNA.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to further modify the modified Torres primer/probe kits, to include a probe that detects rRNA. Torres teaches detecting rRNA as a control gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels, and to incorporate appropriate control reagents for a particular assay, using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Claims 1, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. KT148593.16 (Acinetobacter baumannii strain IPTSP-UFG:ABs:51(2207) class D beta-lactamase OXA-58 (OXA-58), gene, partial CDS, 2015) and An (US 2003/0050470).
Regarding independent claim 1 and dependent claim 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 331-332 and 333 (labeled)/366 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. KT148593.1: 75-97, 364-386 (reverse complement) and 162-190, respectively.
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. KT148593.1 (Acinetobacter baumannii strain IPTSP-UFG:ABs:51(2207) class D beta-lactamase OXA-58 (OXA-58), gene, partial CDS, 2015), as applied to claim 1 above, and further in view of GenBank Accession No. JN358191.1 (Uncultured bacterium clone 4_D_061373_0176_0934 16S ribosomal RNA gene, partial sequence, 2011).
Regarding dependent claim 21, Torres teaches that the kit further comprises instant SEQ
ID NOs: 79-80, 76-77 and 370 (Torres SEQ ID NOs: 79-80, 76-77 and 30, respectively). Torres also teaches detecting rRNA as a control (para. 59).
Regarding instant SEQ ID NOs: 340 (labeled)/369 (unlabeled), these sequences correspond with 100% homology to nucleotides 24-47 of GenBank Accession No. JN358191.1, which corresponds to bacterial 16S rRNA.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to further modify the modified Torres primer/probe kits, to include a probe that detects rRNA. Torres teaches detecting rRNA as a control gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels, and to incorporate appropriate control reagents for a particular assay, using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Claims 1, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. JQ342836.17 (Acinetobacter baumannii strain PKS19 class D beta-lactamase gene, partial cds, 2012) and An (US 2003/0050470).
Regarding independent claim 1 and dependent claim 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 334-335 and 336 (labeled)/367 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. JQ342836.1: 84-104, 549-569 (reverse complement) and 107-136, respectively.
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. JQ342836.1 (Acinetobacter baumannii strain PKS19 class D beta-lactamase gene, partial cds, 2012), as applied to claim 1 above, and further in view of GenBank Accession No. JN358191.1 (Uncultured bacterium clone 4_D_061373_0176_0934 16S ribosomal RNA gene, partial sequence, 2011).
Regarding dependent claim 21, Torres teaches that the kit further comprises instant SEQ
ID NOs: 79-80, 76-77 and 370 (Torres SEQ ID NOs: 79-80, 76-77 and 30, respectively). Torres also teaches detecting rRNA as a control (para. 59).
Regarding instant SEQ ID NOs: 340 (labeled)/369 (unlabeled), these sequences correspond with 100% homology to nucleotides 24-47 of GenBank Accession No. JN358191.1, which corresponds to bacterial 16S rRNA.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to further modify the modified Torres primer/probe kits, to include a probe that detects rRNA. Torres teaches detecting rRNA as a control gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels, and to incorporate appropriate control reagents for a particular assay, using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Claims 1, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. KY439042.18 (Acinetobacter baumannii strain Yazd-32 beta-lactamase OXA-23 (blaOXA23) gene, partial cds, 2017), GenBank Accession No. KU310908.19 (Acinetobacter baumannii carbapenemas M1-like (OXA-23) gene, partial sequence, 2016) and An (US 2003/0050470).
Regarding independent claim 1 and dependent claim 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 337 and 339 (labeled)/368 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. KY439042.1: 115-138 and 154-177, respectively.
Regarding instant SEQ ID NO: 338, this sequence corresponds with 100% homology to the following positions on GenBank Accession No. KU310908.1: 7-60 (reverse complement).
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. KY439042.1 (Acinetobacter baumannii strain Yazd-32 beta-lactamase OXA-23 (blaOXA23) gene, partial cds, 2017), GenBank Accession No. KU310908.1 (Acinetobacter baumannii carbapenemas M1-like (OXA-23) gene, partial sequence, 2016), as applied to claim 1 above, and further in view of GenBank Accession No. JN358191.1 (Uncultured bacterium clone 4_D_061373_0176_0934 16S ribosomal RNA gene, partial sequence, 2011).
Regarding dependent claim 21, Torres teaches that the kit further comprises instant SEQ
ID NOs: 79-80, 76-77 and 370 (Torres SEQ ID NOs: 79-80, 76-77 and 30, respectively). Torres also teaches detecting rRNA as a control (para. 59).
Regarding instant SEQ ID NOs: 340 (labeled)/369 (unlabeled), these sequences correspond with 100% homology to nucleotides 24-47 of GenBank Accession No. JN358191.1, which corresponds to bacterial 16S rRNA.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to further modify the modified Torres primer/probe kits, to include a probe that detects rRNA. Torres teaches detecting rRNA as a control gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels, and to incorporate appropriate control reagents for a particular assay, using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Claims 1, 20, 25 and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Torres (WO 2017/218789 A1) in view of GenBank Accession No. MF594724.1 (Acinetobacter pittii strain 1-1175 OXA-143 family carbapenem-hydrolyzing class D beta-lactamase-like protein (blaOXA) gene, partial cds, 2018), GenBank Accession No. MG254523.1 (Acinetobacter baumannii strain KK-AB:12 class D beta-lactamase OXA-24 (blaOXA gene), blaOXA-24 allele, partial cds, 2018), GenBank Accession No. KT148593.1 (Acinetobacter baumannii strain IPTSP-UFG:ABs:51(2207) class D beta-lactamase OXA-58 (OXA-58), gene, partial CDS, 2015), GenBank Accession No. JQ342836.1 (Acinetobacter baumannii strain PKS19 class D beta-lactamase gene, partial cds, 2012), GenBank Accession No. KY439042.1 (Acinetobacter baumannii strain Yazd-32 beta-lactamase OXA-23 (blaOXA23) gene, partial cds, 2017), GenBank Accession No. KU310908.1 (Acinetobacter baumannii carbapenems M1-like (OXA-23) gene, partial sequence, 2016) and An (US 2003/0050470).
Regarding independent claim 1 and dependent claims 20 and 25, Torres teaches
primer/probe kits for detecting various antibiotic resistance genes including, e.g., beta-lactamase genes such as OXA (paras. 10-11). Torres teaches that the probes can be labeled with various labels, including, e.g., a FRET pair (para. 35).
Regarding instant SEQ ID NOs: 322-323 and 324 (labeled)/364 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. MF594724.1: 140-165, 382-406 (reverse complement) and 312-336, respectively.
Regarding instant SEQ ID NOs: 328-329 and 330 (labeled)/365 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. MG254523.1: 158-183, 390-411 (reverse complement) and 329-357, respectively.
Regarding instant SEQ ID NOs: 331-332 and 333 (labeled)/366 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. KT148593.1: 75-97, 364-386 (reverse complement) and 162-190, respectively.
Regarding instant SEQ ID NOs: 334-335 and 336 (labeled)/367 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. JQ342836.1: 84-104, 549-569 (reverse complement) and 107-136, respectively.
Regarding instant SEQ ID NOs: 337 and 339 (labeled)/368 (unlabeled), these sequences correspond with 100% homology to the following positions on GenBank Accession No. KY439042.1: 115-138 and 154-177, respectively.
Regarding instant SEQ ID NO: 338, this sequence corresponds with 100% homology to the following positions on GenBank Accession No. KU310908.1: 7-60 (reverse complement).
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can 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 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 1 (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” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan 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.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to practice the Torres method with primer/probe kits, and modify the primer/probe kits to arrive at the instantly claimed invention. Torres teaches the use of primer/probe kits, and teaches that the probes can be labeled. Torres also teaches the significance of detecting the OXA gene. One of ordinary skill in the art would have been motivated to modify the Torres primer/probe kits to optimize the primers/probes and the probe labels for a particular assay using the GenBank Accession Nos. and the teachings of An, and would have had an expectation of success, as such modifications are well known in the art.
Regarding dependent claims 40-48, Torres additionally teaches that the components are comprised within a container (e.g., paras. 11, 64), as recited in claim 48. Torres further teaches that each of the probes is labeled with a fluorophore, optionally FAM, HEX, TEX615, or TYE665, on one end and a quencher, optionally Iowa Black or Black Hole, on the other end (paras. 35, 84; Table 1), and optionally a second quencher (para. 35, Table 1: e.g., SEQ ID NOs: 69 and 72 with ZEN internal quencher), as recited in claims 40-44 and 46. Finally, Torres teaches that the fluorophore excites between 450 nm and 763 nm and emits between 500 nm and 800 nm (para. 84), as recited in claim 45, and that the peak absorbance of the fluorescent quencher is at 531 nm, 34 nm, 578 nm or 656 nm (para. 84), as recited in claim 47.
Regarding dependent claim 49, Torres additionally teaches the kit comprises a tracking dye (para. 54).
Prior Art
Regarding dependent claim 22, Torres teaches that the kit further comprises instant SEQ ID NOs: 58 and 264 (Torres, 58 and 264, respectively). However, at least, SEQ ID NO. 350 is not known in the art. Thus, claim 22 is free of the art.
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 20 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 and 14 of copending Application No. 19/485,594 (hereinafter, the ‘594 application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘594 application claim 3 teaches kits for identifying OXA, wherein the kit comprises one or more primers/probes, including SEQ ID NOs. 322-323 and 328-329, and probes 364/324, 365/330, 366/333, 367/336 and 368/339. The ‘594 application claim 4 teaches probe 369/340. The ‘594 application claim 5 teaches SEQ ID NOs. 331-332, 334-335 and 337-338. The ‘594 application claim 14 teaches probes comprising a label.
Thus, these claims of the ‘594 application teach all of the limitations of at least some embodiments of instant claims 1, 20 and 25, albeit in different embodiments.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to modify the ‘594 application primer/probe kits to arrive at the instantly claimed invention. The ‘594 application teaches primer/probe kits for detecting the OXA gene, and teaches that the probes can be labeled. One of ordinary skill in the art would have been motivated to modify the ‘594 application primer/probe kits to optimize the primers/probes and the probe labels for a particular assay, and would have had an expectation of success, as such modifications are well known in the art.
Claims 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 19/485,594 in view of Torres (WO 2017/218789 A1).
This is a provisional nonstatutory double patenting rejection.
The ‘594 application claims 10-11 teach kits comprising SEQ ID NOs: 58, 264 and 349-
353, and the ‘594 application claim 4 teaches SEQ ID NOs: 76-77 and 340. In addition, Torres teaches that the kit further comprises instant SEQ ID NOs: 79-80 and 370 (Torres SEQ ID NOs: 79-80 and 30, respectively).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to modify the ‘594 application primer/probe kits to add primers/probes of Torres to arrive at the instantly claimed invention. The ‘594 application teaches primer/probe kits for detecting the OXA gene, and teaches that the probes can be labeled. One of ordinary skill in the art would have been motivated to modify the ‘594 application primer/probe kits to optimize the primers/probes and the probe labels for a particular assay, and would have had an expectation of success, as such modifications are well known in the art.
Conclusion
Claims 1, 20-22, 25 and 40-49 are being examined. Claims 1, 20-21, 25 and 40-49 are rejected. Claim 22 is objected to, but is otherwise directed to allowable subject matter. No claims are allowed.
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/CAROLYN L GREENE/Examiner, Art Unit 1681
1 Torres was cited in the Information Disclosure Statement submitted July 26, 2023.
2 GenBank Accession No. MF594724.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
3 An was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
4 GenBank Accession No. JN358191.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
5 GenBank Accession No. MG254523.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
6 GenBank Accession No. KT148593.1 was cited in the PTO-892 Notice of References mailed December 5, 2025.
7 GenBank Accession No. JQ342836.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
8 GenBank Accession No. KY439042.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.
9 GenBank Accession No. KU310908.1 was cited in the PTO-892 Notice of References Cited mailed December 5, 2025.