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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-19, drawn to a method.
Group II, claim(s) 21, drawn to a kit.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical features of:
an isothermal amplification reaction mixture, a DNA polymerase with 3’-5’ exonuclease activity, and a detection probe, wherein the isothermal amplification reaction mixture comprises a primer set of at least two primers, wherein each primer recognises a distinct primer binding site within the target nucleic acid molecule, wherein the detection probe is a single-stranded probe that recognises a probe binding site within target amplicons, said probe binding site being different from and non-overlapping with any one of the primer binding sites, and wherein the detection probe comprises at least one 3' end nucleotide mismatch and a quencher-fluorophore pair at opposite ends of the probe at a distance that allow the quencher to quench the fluorophore signal, wherein either the fluorophore or the quencher are attached to the 3' end of the probe downstream of or at the site of the mismatch, wherein the detection probe can hybridize to said target amplicons under isothermal amplification assay conditions except for the 3' end nucleotide mismatch and form a double-stranded probe:target complex,
these technical features are not special technical features as they do not make a contribution over the prior art in view of Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)). Ding teaches an isothermal amplification reaction mixtures comprising a primer set of at least two primers with distinct primer binding sites within the target nucleic acid molecule (LAMP reaction with Proofman probes, Figure 1A; Abstract). Ding teaches using a DNA polymerase with 3’-5’ exonuclease activity (proofreading DNA polymerase (Pfu); 3.1. The principle of proofman coupled with LAMP). Ding teaches a single-stranded detection probe that recognizes a probe binding site within target amplicons which is different from and non-overlapping with any one of the primer binding sites (Figure 1B). Ding teaches that the detection probe comprises a mismatch at the 3’ end and a quencher-fluorophore pair at opposite ends of the probe at a distance that allows the quencher to quench the fluorophore signal wherein the fluorophore is downstream of the mismatch at the 3’ end of the probe (3.1. The principle of proofman coupled with LAMP, Figure 1B). Ding teaches that the detection probe can hybridize to the target amplicons under isothermal amplification assay conditions except for the 3’ end nucleotide mismatch and form a double-stranded probe:target complex (3.1. The principle of proofman coupled with LAMP, Figure 1B).
During a telephone conversation with Douglas Digirolamo (Attorney of Record) on 5/22/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 21 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement (see paragraph [0105]). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. See Figures 1 and 12.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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.
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). See paragraphs [0136] and [0140] (Table 3)).
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.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0051] contains a reference to “red letters” in Figure 12. Paragraph [067] contains a reference to “yellow” and “dashed dark green or pink lines” in Figure 28. Given that the drawings will be in black and white (unless a petition is filed to include color drawings), please try not to use references to colors in the figures.
Appropriate correction is required.
The use of the terms “LightCycler” (paragraph [006]), “FAM” (paragraph [040]), “WarmStart” (paragraph [055]), “ZeroPrep” (paragraph [065]), which are trade names or marks used in commerce, have been noted in this application. These terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The examples above are not an exhaustive list of unmarked trade names or marks used in commerce throughout the specification. Please carefully read through and properly notate each instance.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 13, claim 1 reads “a quencher-fluorophore pair at opposite ends of the probe at a distance that allow the” and should read “a quencher-fluorophore pair at opposite ends of the probe at a distance that allows the” to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112b - Indefiniteness
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 11 and 15 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 11 recites the limitation "the detection" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this is being treated as a typo, in which the claim should read “the detection probe” in line 3, which is consistent with the 5’ end of the detection probe being defined in line 2. However, further clarification is required.
Claim 15: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “a nucleic acid of a pathogen”, and the claim also recites “preferably a bacterial, fungal, parasite, or viral nucleic acid molecule or a cDNA reverse transcript of a bacterial, fungal, parasite or viral RNA” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-7, 10-11, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)).
Claim 1: Ding teaches a method of determining the presence of a target nucleic acid molecule in a sample using isothermal amplification (Abstract). Ding teaches an isothermal amplification reaction mixture comprising a primer set of at least two primers with distinct primer binding sites within the target nucleic acid molecule (LAMP reaction with Proofman probes, Figure 1A; Abstract). Ding teaches using a DNA polymerase with 3’-5’ exonuclease activity (proofreading DNA polymerase (Pfu); 3.1. The principle of proofman coupled with LAMP). Ding teaches a single-stranded detection probe that recognizes a probe binding site within target amplicons which is different from and non-overlapping with any one of the primer binding sites (Figure 1B). Ding teaches that the detection probe comprises a mismatch at the 3’ end and a quencher-fluorophore pair at opposite ends of the probe at a distance that allows the quencher to quench the fluorophore signal wherein the fluorophore is downstream of the mismatch at the 3’ end of the probe (3.1. The principle of proofman coupled with LAMP, Figure 1B). Ding teaches that the detection probe can hybridize to the target amplicons under isothermal amplification assay conditions except for the 3’ end nucleotide mismatch and form a double-stranded probe:target complex (3.1. The principle of proofman coupled with LAMP, Figure 1B). Ding teaches amplifying the target nucleic acid molecule under isothermal conditions that enable generation of the target amplicons, hybridization of the detection probe to the target amplicons, and cleavage of the detection probe at the 3’ end nucleotide mismatch to release a 3’-terminal probe fragment comprising a fluorophore (3.1. The principle of proofman coupled with LAMP, Figure 1). Ding then teaches detecting the released probe fragments to detect the presence of the target nucleic acid molecule in the sample (3.1. The principle of proofman coupled with LAMP).
Claim 2: Ding teaches that the DNA polymerase with 3’-5’ exonuclease activity is a high-fidelity polymerase (Pfu DNA polymerase, 3.1. The principle of proofman coupled with LAMP, Figure 1). Pfu DNA polymerase is listed as a high-fidelity DNA polymerase in the instant specification (paragraph [096]).
Claim 3: Ding teaches that the isothermal amplification is LAMP and that the primer set comprises 4 primers (FIP, BIP, F3, and B3; Figure 1).
Claim 4: Ding teaches that the probe binding site lies between the binding sites of the inner primers (Figure 1B).
Claims 6-7: Ding teaches that the at least one 3’ end nucleotide mismatch comprise a single 3’ end nucleotide mismatch, which is located at the last nucleotide relative to the 3’ end of the detection probe (3.1. The principle of proofman coupled with LAMP, Figure 1).
Claim 10: Ding teaches that the detection probe is 18 nucleotides long (reads on 17-30 nucleotide bases in length; Table S1).
Claim 11: Ding teaches that the quencher is attached to the 5’ end of the detection probe and the fluorophore is attached to the 3’ of the detection probe (Table S1, “1. The highlight nucleotides at 5’ and 3’ end were labeled with BHQ1 and FAM, respectively.”).
Claim 13: Ding teaches that the detection method is fluorescence detection (2.5. Amplification analysis).
Claim 14: Ding teaches a multiplexing method for determining the presence of two or more target nucleic acid molecules in the sample using a different detection probe for each target nucleic acid molecule (3.4. Multiplex detection using RT-proofman-LAMP).
Claims 15-17: Ding teaches that the target nucleic acid molecule is a nucleic acid of a pathogen, specifically a coronavirus, and more specifically SARS-CoV-2 virus (Abstract, 3.2. Establishment of Proofman-based LAMP assay for SARS-CoV-2 detection).
Claim 18: Ding teaches a method in which nucleic acid purification or extraction are not performed on the sample before the isothermal amplification reaction (3.5. Evaluation of the assay using contrived samples, the example specifically pertaining to the “commercial direct lysis buffer” exemplifies a method in which nucleic acids were not purified or extracted from the sample).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)) in view of Martineau (Martineau et al., Analytical Chemistry 2016; cited on IDS of 3/28/2024 (#15)).
The teachings of Ding as they pertain to claims 1 and 3, from which claim 5 depends, are detailed above. Relevant to the instantly rejection claim, Ding teaches an isothermal amplification method (LAMP) that comprises 4 primers (FIP, BIP, F3, and B3; Figure 1).
Ding does not teach including “swarm primers” in the LAMP reaction. However, use of swarm priming in LAMP reaction is known in the art, as taught by Martineau.
Martineau teaches a LAMP reaction in which a new set of primers, “swarm primers”, are added to the reaction (Abstract, Figure 1-2, and Materials and Methods – Swarm Primers).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Ding to include the swarm primers as taught by Martineau. One would be motivated to do so given the assertion by Martineau that the inclusion of swarm primers results in “increased amplification speed, increased indicator contrast, and increase reaction products” (Abstract). One would have a reasonable expectation of success given that Martineau demonstrates swarm primer inclusion in, and enhancement of, LAMP and RT-LAMP reaction (Results – Effect of Swarm Primers, Results - Swarm Primers and RT-LAMP).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)) in view of Li (Li et al., WO 2005/098042 A2).
The teachings of Ding as they pertain to claim 1, from which claims 8 and 9 depend, are detailed above. Relevant to the instantly rejection claim, Ding teaches an isothermal amplification method that employ the use of a detection probe (Proofman probe) which comprises a 3’ fluorophore, a 5’ quencher, and a 3’ nucleotide mismatch. Upon hybridization of the probe to its target amplicons, the 3’ fluorophore is cleaved from the detection probe by a DNA polymerase with 3’-5’ exonuclease activity due to the mismatched nucleotide at the 3’ terminus of the probe.
Ding does not teach incorporating two terminal mismatches in the detection probe (claims 8 and 9). However, incorporation of two terminal mismatches in a detection probe used for real time fluorescent detection of amplicons is known in the art, as taught by Li.
Li teaches a method of amplification product detection using a detection probe with mismatch(es) at the 3’ end attached to a label and a 5’ quenching moiety, wherein the 3’ mismatch is cleaved by an enzyme having 3’ to 5’ exonuclease activity (Abstract, Figure 1, and paragraphs [0006, 0014]). Li teaches a probe that has two mismatches at the 3’ terminus of the probe (paragraphs [0008, 0081, 0085, and 0106]).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Ding to include two mismatches at the 3’ terminus of the detection probe, as taught by Li. One would be motivated to do so given the assertion by Li that the presence of 2 terminal mismatches at the 3’ end resulted in a 2-fold increase in double-stranded exonuclease activity in comparison with probes with only 1 mismatch at the 3’ end (paragraph [0106]). One would have a reasonable expectation of success given that Li is teaching similar probes for the detection of amplification products as those taught by Ding (10 to 40 nucleotides long (paragraph [0078]), quencher-fluorophore pair (paragraph [0014]), 3’ nucleotide mismatch(es)) and teaches that Pfu DNA polymerase can be utilized with this probe type for amplicon detection (paragraphs [0013, 0057]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)) in view of Clokie (Clokie et al., WO 2018/083491 A1).
The teachings of Ding as they pertain to claim 1, from which claim 12 depends, are detailed above. Relevant to the instantly rejected claim, Ding teaches performing an isothermal amplification reaction with 4 primers, a detection probe with a fluorophore-quencher pair and a 3’ end mismatch, and a DNA polymerase with 3’-5’ exonuclease activity.
Ding does not teach that the quencher is a double quencher. However, use of double quenchers in quencher-fluorophore pairs on probes used for amplicon detection is known in the art, as taught by Clokie.
Clokie teaches a method of detecting phage in a sample through examination of particular phage genes (pg 5-6). Clokie teaches amplification of the nucleic acid to be detected and detection by hybridization of a probe with a label (pg 13). One such amplification method embodied is LAMP (pg 14). Clokie teaches a particular exemplification of the TaqMan method in which the TaqMan probe is a “double-quencher”, meaning it contains a quencher at one terminus and an internal quencher in addition to a fluorophore at the opposite terminus of the probe (pg 37).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Ding to include a double quencher in the detection probe, as taught by Clokie. One would be motivated to do so given the assertion by Clokie that “double-quenched probes generate less background and increased signal compared to probes containing a single quencher” (pg 37). One would have a reasonable expectation of success given that the methodology in which Clokie is using the double-quencher probe (TaqMan qPCR) also relies on separation of a fluorophore from a quencher for signal generation based on number of amplicons, a methodology similar to that used in Ding.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ding (Ding et al., Biosens Bioelectron Jan 28, 2021; cited on IDS of 3/28/2024 (#62)) in view of Takano (Takano et al., Scientific Reports 2019).
The teachings of Ding as they pertain to claim 1, from which claim 19 depends, are detailed above. Relevant to the instantly rejected claim, Ding teaches performing an isothermal amplification reaction with 4 primers, a detection probe with a fluorophore-quencher pair and a 3’ end mismatch, and a DNA polymerase with 3’-5’ exonuclease activity.
Ding does not teach including a pyrophosphatase in the isothermal amplification reaction. However, inclusion of a pyrophosphatase in an isothermal amplification reaction, such as LAMP, is known in the art as taught by Takano.
Takano teaches a LAMP reaction performed in the presence of a pyrophosphatase (Discussion, paragraph 9, Figure 1).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Ding to include a pyrophosphatase in the LAMP reaction mixture, as taught by Takano. One would be motivated to do so given the assertion by Takano that pyrophosphate, which is a by-product of the LAMP reaction, “attenuates the activity of a DNA polymerase, and addition of pyrophosphatase can increase the LAMP reaction speed” (Discussion, paragraph 9). One would have a reasonable expectation of success given that Takano demonstrates a successful LAMP reaction in the presence of a pyrophosphatase (Figure 1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILEY E CASH whose telephone number is (571)272-0971. The examiner can normally be reached Monday-Friday 8:30am-6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAILEY ELIZABETH CASH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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