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 .
Priority
This application is a 371 of PCT/US2021/060028 filed 11/19/2021, which claims benefit of US Serial No. 63/117,497 filed on 11/24/2020.
Status of the claims
Claims 1-3, 14-19, 21-23, 34-38, 40, 45 and 47 are pending and under examination. Claims 4-13, 20, 24-33, 39, 41-44 and 46 are canceled.
Specification
The disclosure is objected to because of the following informalities: the specification contains improper sequence identifier notations “SEQ ID NOS.:”.
For example, the specification provides these improper sequence nomenclature on page 6, 2nd , 3rd and last para and om pages 7 and 8 and page 16 and pages 25-26 and pages 38-45.
Please use the notation “SEQ ID NO: X”, or “SEQ ID NO. X”, or “SEQ ID NOS: X-Y”, or “SEQ ID NOS. X-Y”, throughout the specification. Appropriate correction is required.
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Appropriate correction is required.
Claim Interpretation
Prior to analysis of the art, the claims must be construed. As noted in MPEP 2111, citing Phillips v. AWH Corp., 415 F.3d l303, 75 USPQ2d l321 (Fed. Cir. 2005), "During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification.' ".
Claim 1 is construed as being directed to primer sets comprising LAMP primers suitable for detection of a multiplicity of bacterial genomes selected from the group consisting of Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales. The primers are designed according to a prior art LAMP primer design scheme such as the one taught by Fukuta et al .(2013) below.
Fukuta et al. (2013, European journal of plant pathology, 136(4), pp.689-701)
Fukuta et al. (2013) teach a scheme for design of a primer set for conducting LAMP (see pg 691, Fig. 1, also reproduced below).
PNG
media_image1.png
614
1104
media_image1.png
Greyscale
Concerning claims 1-2
The Lactobacillales LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 1, the B3 primer consisting SEQ ID NO: 2, the FIP primer consisting SEQ ID NO: 3 and the BIP primer consisting SEQ ID NO: 4, and optionally, at least one of the LF primer consisting SEQ ID NO: 5 and/or the LB primer consisting SEQ ID NO: 6.
The Staphylococcus LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 7, the B3 primer consisting SEQ ID NO: 8, the FIP primer consisting SEQ ID NO: 9 and the BIP primer consisting SEQ ID NO: 10, and optionally, at least one of the LF primer consisting SEQ ID NO: 11 and/or the LB primer consisting SEQ ID NO: 12.
The Acinetobacter LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 13, the B3 primer consisting SEQ ID NO: 14, the FIP primer consisting SEQ ID NO: 15 and the BIP primer consisting SEQ ID NO: 16, and optionally, at least one of the LF primer consisting SEQ ID NO: 17 and/or the LB primer consisting SEQ ID NO: 18.
The Enterobacterales LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 19, the B3 primer consisting SEQ ID NO: 20, the FIP primer consisting SEQ ID NO: 21 and the BIP primer consisting SEQ ID NO: 22, and optionally, at least one of the LF primer consisting SEQ ID NO: 23 and/or the LB primer consisting SEQ ID NO: 24.
The Pasteurellales LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 25, the B3 primer consisting SEQ ID NO: 26, the FIP primer consisting SEQ ID NO: 27 and the BIP primer consisting SEQ ID NO: 28, and optionally, at least one of the LF primer consisting SEQ ID NO: 29 and/or the LB primer consisting SEQ ID NO: 30.
The Pseudomonadales LAMP primers include primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 31, the B3 primer consisting SEQ ID NO: 32, the FIP primer consisting SEQ ID NO: 33 and the BIP primer consisting SEQ ID NO: 34, and optionally, at least one of the LF primer consisting SEQ ID NO: 35 and/or the LB primer consisting SEQ ID NO: 36.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 recites the limitation “(vi)… bacterial species selected from the group consisting of: Acinetobacter ursingii”. Please delete the semicolon following the word “of” in the limitation noted above.
Claim 45 is objected to because of the following informalities: Claim 45 recites the limitation “comprises genomes from two or more bacterial species selected from the group consisting of:”. Please delete the semicolon following the word “of” in the limitation noted above.
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 14-19, 21-23, 35-38, 40, 45 and 47 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.
Claim 14 recites the limitation, “wherein each ..primer comprises a nucleotide sequence having at least 71 %, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81 %, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOS: 1-36”. This limitation is confusing and renders claim 14 indefinite.
Claim 14 lacks both clarity and clarity of scope.
Because of how this limitation is presently recited, it is unclear how to relate e.g. the set of claim 1 i.e. a LAMP primer set for detection of Lactobacillales, said set comprising LAMP F3, B3, FIP and BIP primers having at least 70% percent identity to SEQ NO: 1, 2, 3 and 4 respectively, to each one of the instant SEQ ID NOS 1-36 as claimed.
It is unknown whether claim 14 e.g. intends each one of the F3, B3, FIP and BIP primers for detection of Lactobacillales to each further comprise a nucleotide sequence that is at least 71% and up to 100% identity of each nucleotide sequence(s) consisting of SEQ ID NOS: 1-36.
Because of the recited limitation “SEQ ID NOS: 1-36”, it is unclear if claim 14 is requiring a single LAMP primer set consisting the F3, B3, FIP, BIP, LB and LF primers for detecting each one of Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales.
Claim 15 recites the limitation, “wherein each nucleic acid primer comprises a nucleotide sequence that does not have any consecutive nucleotide substitutions relative to SEQ ID NOS: 1-36”.
This limitation is confusing and renders claim 15, indefinite.
Claim 15 lacks both clarity and clarity of scope.
Because of the recited limitation “SEQ ID NOS: 1-36”, it is unclear if claim 15 is requiring a single LAMP primer set consisting of the F3, B3, FIP, BIP, LB and LF primers for detecting each one of Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales and further requiring that every one of these primers have no nucleotide substitutions relative to SEQ ID NOS: 1-36.
Claim 16 recites the limitation, “wherein each nucleic acid primer comprises a nucleotide sequence that does not have any nucleotide substitutions relative to SEQ ID NOS: 1-36, respectively, within the last 5, 6, or 7 nucleotides of the ‘3 end of the nucleotide sequence”.
This limitation is confusing and renders claim 16, indefinite.
For example for the LAMP primer set for detecting of Lactobacillales of claim 1, said set comprising primers with 71% identity to SEQ ID NO: 1, 2, 3 and 4 respectively, it is unclear whether or not this limitation of claim 16 is directed to, and requires any nucleotide changes when compared to the nucleotide sequences of SEQ ID NO: 1, 2, 3 and 4.
Claim 16 lacks both clarity and clarity of scope.
Claim 17 recites the limitation, “wherein the primers mediate amplification of one or more conserved regions of the bacterial genomes, optionally wherein the one or more conserved regions comprise a 16S, 23S, and/or rpoB gene sequence”.
This limitation is confusing and renders claim 17, indefinite.
For example, for the LAMP primer set for detecting of Lactobacillales of claim 1, said set comprising primers with 71% identity to SEQ ID NO: 1, 2, 3 and 4 respectively, it is unclear whether or not this limitation of claim 17 requires each primer with 71% identity to SEQ ID NO: 1, 2, 3 and 4 respectively to hybridize to a 16S, 23S, and/or rpoB gene sequence.
It is unclear how these LAMP primers (e.g. with 71% identity to SEQ ID NO: 1, 2, 3 and 4 respectively) would be able to hybridize to, and mediate an amplification of a 16S and rpoB gene sequence, or to a 23S gene sequence or to a rpoB gene sequence.
The instant SEQ ID NO: 1, 2, 3 and 4 are exclusively and selectively designed to bind and amplify to conserved 16S gene nucleotide sequence(s).
Claim 17 lacks both clarity and clarity of scope.
Claim 18 recites the limitation, “wherein the multiplicity of bacterial genomes comprises genomes from two or more bacterial species”.
This limitation is confusing and renders claim 18, indefinite.
Claim 18 lacks both clarity and clarity of scope.
The limitation fails to relate the claimed multiplicity of bacterial genomes to what is intended by “two or more bacterial species”. It is unclear whether the “two or more bacterial species” as claimed refer to bacterial species that are member of the order of Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales; or whether “two or more bacterial species” refer to something else.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite because of the presence of the Markush grouping limitation “selected from the group consisting of the sets according to claim 1”.
Because of the underlined phrase “the sets according to claim 1”, as noted in the limitation of claim 19 above, claim 19 lacks both clarity and clarity of scope.
Claim 1 recites the limitation, “wherein the set is selected from the group consisting of...”, the Office construes claim 1 as being directed to one set from the following distinct sets of LAMP primers, i.e. a primer set for detecting Lactobacillales, or a primer set for detecting Staphylococcus, or a primer set for detecting Acinetobacter, or a primer set for detecting Enterobacterales, or a primer set for detecting Pasteurellales, or a primer set for detecting Pseudomonadales.
Claim 19 is rejected as the meaning and scope of what constitutes “the sets according to claim 1” as recited by claim 19 is unclear. Claim 19 should make clear which of the primer set recited by claim 1 belongs to the group consisting of the sets, or Applicant should amend claim 19 in a manner to make clear which combinations of the recited LAMP primer sets of claim 1 are required for claim 19.
Claims 15, 16, 21 and 35 each recite in various instances the limitation(s) “SEQ ID NOS.:”
Claims 15, 16, 21 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite because the limitation “SEQ ID NOS.:” constitute an improper sequence nomenclature form. Claim 15, 16, 21 and 35 do not properly recite nucleotide sequence(s) with their assigned sequence identifier in the manner as required by 37 CFR 1.821 (d). See MPEP 2422.03: 37 CFR 1.821 (d) for guidance.
To obviate this rejection, please replace the symbol ".:" following "SEQ ID NO" with either ":" (i.e. a semicolon) or with "." (a period). In other word, please amend to either SEQ ID NO: X or SEQ ID NO. X. Claims 22-23 and 34 and 36-37 are further rejected as they depend from claim 21.
Claim 34 recites the limitation, wherein at least one set further comprises one or more additional isolated nucleic acid primers…”. Claim 34 lacks clarity and clarity of scope as it is a claim that depends from claim 21 and claim 21 is directed to two or more sets, up to six sets. It is unclear whether claim 34 is directed to apply only to one set from the two or more sets, or whether claim 34 is directed to every one of the selected sets of claim 21 having additional LAMP primer(s).
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 35 recites the limitation, “wherein each nucleic acid primer comprises a nucleotide sequence having at least 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOS: 1-36, respectively”.
Claim 35 lacks both clarity and clarity of scope.
Because of how this limitation is presently recited, it is unclear how to relate e.g. the two or more sets as claimed by claims 21 and 35 e.g. a LAMP primer set for detection of Lactobacillales in combination with a LAMP primer set for detection of Staphylococcus, said set comprising LAMP F3, B3, FIP and BIP primers having at least 70% percent identity to SEQ NOS: 1 and 7, SEQ NOS: 2 and 8, SEQ NOS: 3 and 9 and SEQ NOS: 4 and 10 respectively to each one of the instant SEQ ID NOS 1-36.
It is unknown whether claim 35 e.g. intends each one of the F3, B3, FIP and BIP primers for detection of Lactobacillales and Staphylococcus to each further comprise a nucleotide sequence that is at least 71% and up to 100% identity of each nucleotide sequence(s) consisting of SEQ ID NOS: 1-36.
Because of the recited limitation “SEQ ID NOS: 1-36”, it is unclear if claim 35 is requiring a single LAMP primer set consisting every F3, B3, FIP, BIP, LB and LF primers for detecting each one of Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 36 recites the limitation, “wherein the primers mediate amplification of one or more conserved regions of the bacterial genome, optionally wherein the one or more conserved regions comprise a 16S, 23S, and/or rpoB gene sequence”. This limitation of claim 36 lacks clarity and clarity of scope because the LAMP primers having at least 70% identity to SEQ ID NOS: 1-4, 7-10, 13-16, 19-22, 25-28, 25-28 or 31-34 respectively, are not shown to possess the functional ability as primers for mediating amplification of one or more conserved regions comprising a 16S, 23S, and/or rpoB gene sequence.
In contrast to the limitation as recited by claim 36, only the LAMP primers that are 100% identical to SEQ ID NOS: 1-2, 7-8, 13-14, 19-20, 25-26 and 31-32 appear to have the functional ability of fully hybridizing to a 16S conserved sequence(s) and mediating an amplification of a 16S nucleotide sequence.
Claim 37 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 37 recites the limitation, “wherein the multiplicity of bacterial genomes comprises genomes from two or more bacterial species”. Claim 37 depends from claim 35 yet claim 35 does not establish how to identify a bacterial species related to the claimed bacterial genomes Lactobacillales, Staphylococcus, Acinetobacter, Enterobacterales, Pasteurellales and Pseudomonadales. Accordingly, it is not known which two or more bacterial species should be characterized as members belonging to the instant bacterial genomes of claim 35.
Claims 38 and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 38 recites the limitation, “(a) providing a reaction mixture comprising at least one set according to claim 1, dNTPs” and claim 40 recites the limitation “at least two sets of nucleic acid primers selected from the sets according to claim 1”. Claims 38 and 40 are rejected as being confusing and indefinite because of the phrase “at least one set according to claim 1” and “the sets according to claim 1” respectively.
Claim 38 and claim 40 each depend from claim 1 and claim 1 is drawn to an individual primer set suitable for LAMP, wherein the LAMP primer set is a primer set for detecting Lactobacillales, or a primer set for detecting Staphylococcus, or a primer set for detecting Acinetobacter, or a primer set for detecting Enterobacterales, or a primer set for detecting Pasteurellales or a primer set for detecting Pseudomonadales.
It is unclear whether claim 38 and claim 40 truly require the individual LAMP primer set as claimed by claim 1, or whether claim 38 and 40 intend a combination(s) of any two or more LAMP primer sets selected from the LAMP primer set for detecting Lactobacillales comprising of primers having at least 70% identity to SEQ ID NOS:1-4 respectively, the LAMP primer set for detecting Staphylococcus comprising of primers having at least 70% identity to SEQ ID NOS: 7-10 respectively, the LAMP primer set for detecting Acinetobacter comprising of primers having at least 70% identity to SEQ ID NOS: 13-16 respectively, the LAMP primer set for detecting Enterobacterales comprising of primers having at least 70% identity to SEQ ID NOS:19-22 respectively, the LAMP primer set for detecting Pasteurellales comprising of primers having at least 70% identity to SEQ ID NOS:25-28 respectively, and the LAMP primer set for detecting Pseudomonadales comprising of primers having at least 70% identity to SEQ ID NOS: 31-34 respectively.
Claim 47 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 47 omits essential process steps. Specifically, claim 47 is directed to a method of detecting a multiplicity of bacterial genomes yet claim 47 omits reciting any process(es) or step(s) that would be useful to establish the preamble limitation of detecting a multiplicity of bacterial genomes.
Applicant is reminded that a claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
To obviate the rejection, applicant may amend the claims by providing the language, “The method of detecting a multiplicity of bacterial genomes comprising…” which should be followed with any relevant methods steps, recited as positive, active process steps in accordance with the guidelines from Ex parte Erlich 3 USPQ 2d 1011 (e.g. providing the primers consisting SEQ ID Nos: 1-6 and performing a LAMP and detecting the LAMP products, thereby detecting one or more bacterial genomes).
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because the claim is directed to a kit but does not clearly indicate the content or composition of the claimed kit. It is unclear if the kit of claim 40 simply requires at least any two LAMP primers recited in claim 1; or whether claim 40 requires the instant kit that to comprise at least two LAMP primers from the LAMP primer set for detecting Lactobacillales, and at least two LAMP primers from the primer set for detecting Staphylococcus, and at least two LAMP primers from the LAMP primer set for detecting Acinetobacter, and at least two LAMP primers from the LAMP primer set for detecting Enterobacterales, and at least two primers from the LAMP primer set for detecting Pasteurellales and at least two primers from the LAMP primer set for detecting Pseudomonadales.
Claim 47 is again rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because claim 47 depends from claim 40 which itself is drawn to a kit. The limitation of “using the kit of claim 40” as recited by claim 47 confuses the ordinary skilled artisan as to whether claim 47’s intent is to require a process, or an article of manufacture/a composition of matter.
Conclusion
Claims 1-3 are free of the prior art and are in condition to be allowed. However, because claims 14-19, 21-23, 34-38, 40, 45 and 47 are rejected in view of the outstanding objection(s) and rejection(s) that are stated above, the application is not in condition to be allowed.
Closest prior art
The closest prior art reference(s) is/are:
(a) Bergmark et al. (2012, FEMS microbiology letters, 333(1), pp.77-84);
(b) Sonaty, G.T., (2015, Undergraduate Honors Theses from Department of Bio Engineering, University of Arkansas, Fayetteville);
(c) Zhang et al. (2015, International Journal of Clinical and Experimental Medicine, 8(5), p.7881-7889;
(d) Si et al. (Epub Sept 27, 2021, Journal of Microbiological Methods, 190, 106339, pp.1-7).
Bergmark et al. teach a highly specific quantitative PCR assay that provides primers targeting different multivariate regions of the 16S rRNA gene targeting the bacterial genera Pseudomonas.
Sonaty teach four LAMP primer sets targeted toward hypervariable/conserved boundaries of the 16S rRNA gene (pg 47, Table 3), each of the LAMP primer sets taught by Sonaty comprise F3, B3, FIP and BIP primers that are used together in a combination to detect either Bacillales, Enterobacillales, Lactobacillales or Pseudomonadales.
Zhang et al. teach LAMP primer sets for pathogenic bacteria (see pg7883, Table 2).
The F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting S. pneumoniae target the lytA gene;
the F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting S. aureus target the femA gene;
the F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting E. coli target the phoA gene;
the F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting K. pneumoniae target KPN_04473 gene;
the F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting P. aeruginosa target the oprl gene; and
the F3, B3, FIP, BIP, LF and LB LAMP primers of the LAMP primer set for detecting A. baumanni target the adeS gene.
Si et al. teach a LAMP assay for the detection of eight common lower respiratory pathogens, including Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis.
None of these cited references nor the prior art teach the LAMP primer set consisting
Lactobacillales detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 1, the B3 primer consisting SEQ ID NO: 2, the FIP primer consisting SEQ ID NO: 3 and the BIP primer consisting SEQ ID NO: 4, and optionally, at least one of the LF primer consisting SEQ ID NO: 5 and/or the LB primer consisting SEQ ID NO: 6.
None of these cited references nor the prior art teach the following LAMP primer set consisting Staphylococcus detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 7, the B3 primer consisting SEQ ID NO: 8, the FIP primer consisting SEQ ID NO: 9 and the BIP primer consisting SEQ ID NO: 10, and optionally, at least one of the LF primer consisting SEQ ID NO: 11 and/or the LB primer consisting SEQ ID NO: 12.
None of these cited references nor the prior art teach the LAMP primer set consisting Acinetobacter detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 13, the B3 primer consisting SEQ ID NO: 14, the FIP primer consisting SEQ ID NO: 15 and the BIP primer consisting SEQ ID NO: 16, and optionally, at least one of the LF primer consisting SEQ ID NO: 17 and/or the LB primer consisting SEQ ID NO: 18.
None of these cited references nor the prior art teach the LAMP primer set consisting Enterobacterales detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 19, the B3 primer consisting SEQ ID NO: 20, the FIP primer consisting SEQ ID NO: 21 and the BIP primer consisting SEQ ID NO: 22, and optionally, at least one of the LF primer consisting SEQ ID NO: 23 and/or the LB primer consisting SEQ ID NO: 24.
None of these cited references nor the prior art teach the LAMP primer set consisting Pasteurellales detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 25, the B3 primer consisting SEQ ID NO: 26, the FIP primer consisting SEQ ID NO: 27 and the BIP primer consisting SEQ ID NO: 28, and optionally, at least one of the LF primer consisting SEQ ID NO: 29 and/or the LB primer consisting SEQ ID NO: 30.
None of these cited references nor the prior art teach the LAMP primer set consisting Pseudomonadales detecting primers having at least 70% identity to the F3 primer consisting SEQ ID NO: 31, the B3 primer consisting SEQ ID NO: 32, the FIP primer consisting SEQ ID NO: 33 and the BIP primer consisting SEQ ID NO: 34, and optionally, at least one of the LF primer consisting SEQ ID NO: 35 and/or the LB primer consisting SEQ ID NO: 36.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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