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 .
Claims 1-31 are pending and are being examined on the merits.
Information Disclosure Statement
The information disclosure statement filed March 11, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the IDS includes citations to 34 NPL documents, however, none of these 34 citations is complete. MPEP 609 and 37 CFR 1.98(b) state …
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At least the title is missing from each citation. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Further, NPL 34 on the IDS is listed as “L. Schultz, University of Arkansas, 2021”. While Applicant did submit a document apparently corresponding to that entry, the citation is incorrect (in addition to being incomplete) and the corresponding document is missing numerous pages. That is, the author of NPL 34 is “Aubrey Lynn Schultz” or “A.L. Schultz”, not “L. Schulz”. “Aubrey Lynn Schultz” is apparently the same person as the inventor in the instant case. Further, the document submitted by Applicant is 10 pp. long, and includes only introductory pages and the Introduction section. The actual document, which is publicly available, is 83 pp. long. Thus, the document submitted by Applicant omits 73 pp. The full-length 83 pp. original document has been retrieved and reviewed by the Examiner and is entered on the corresponding PTO-892 Notice of References Cited attached to this Action.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Specifically, there are embedded hyperlinks in Refs. 4 and 6 on p. 53.
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 6, 12-19, 21-22 and 27-30 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.
Indefiniteness rejections
Claim 6 recites “the heater comprises … an external hot-plate or stove top”, the meaning of which is unclear. Specifically, claim 6 depends from claim 1, which recites that the heater is “disposed in the housing”. It is not clear then how a heater can be both inside a housing and, at the same time, an external hot-plate or stove top. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claim 6 recites, in part, “the heater comprises a … PTC heater, an electric or gas-powered flame, burning coal or embers, an external hot-plate or stove top, nichrome wire and/[] boiling water”, the meaning of which is unclear. Specifically, it is unclear how at least some of these heating embodiments could be used together. For example, how would a gas-powered flame be combined with boiling water, or how would a PTC heater be combined with burning coal? Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claim 12 recites “the … heat sink is in contact with the bottom of the cup and is partially submerged in the PCM”, the meaning of which is unclear. The instant specification does not define “partially submerged”, however, the ordinary artisan would understand the plain meaning of the term to indicate that the heat sink is surrounded by the PCM on the bottom and on the sides. How then is the bottom heat sink both surrounded by the PCM and, at the same time, in contact with the bottom of the cup? Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claims 13-14 and 16 depend directly or indirectly from claim 12, and consequently
incorporates the indefiniteness issues of claim 12.
Claim 13 recites “the … heat sink has center holes that are configured to fill with the PCM”, the meaning of which is unclear. Specifically, what configuration does a hole have to have to be capable of being filled with a material, other than merely being a hole? Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claim 14 depends from claim 13, and consequently incorporates the indefiniteness
issues of claim 14.
Claim 15 recites the limitation “wherein the … heat sink is adapted to increase the thermal conductivity of the PCM allowing for rapid heating and electricity-free incubation”, the meaning of which is unclear. Specifically, it is unclear whether the “adapted to” limitation is merely expressing a property of the heat sink, or if it is intended to impose some additional functional limitation on the heat sink and/or “only states a problem [to be] solved”. Further, if it is the latter, it is unclear what structure of the heat sink or additional components would be required to produce that functionality or solve that problem. See MPEP 2173.05(g).
Regarding claim 17, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Specifically, it is not clear how similar a heat sink would have to be to the recited metals to be considered “like” those compounds. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claim 18 depends from claim 17, and consequently incorporates the indefiniteness
issues of claim 17.
Claim 19 recites the limitation “wherein the PCM is adapted for regulating the temperature to avoid the complexity of a microcontroller”, the meaning of which is unclear. Specifically, it is unclear whether the “adapted for” limitation is merely expressing a property of the PCM, or if it is intended to impose some additional functional limitation on the PCM and/or “only states a problem [to be] solved”. Further, if it is the latter, it is unclear what structure of the PCM would be required to produce that functionality or solve that problem. See MPEP 2173.05(g).
Claims 21-22 contain the trademarks/trade names “PureTemp”, while claim 30 contains the trademark/trade name “SYBR”. 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 trademarks/trade names are used to identify/describe the source of components of nucleic acid amplification devices and the source of nucleic acid assay reagents and, accordingly, the identification/description is indefinite.
Claim 30 recites the limitation “illustrating the mixture with UV light”, the meaning of which is unclear. Specifically, the term “illustrating” does not have any fixed or particular meaning in the nucleic acid assay arts, nor does the specification define the term. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite. For purposes of further examination, the term will be considered to mean “illuminating” or something similar.
Lack of antecedent basis
Claim 18 recites the limitation “the cup” in l. 1. There is insufficient antecedent basis for this limitation in the claim. Neither of claims 1 or 17, from which claim 18 indirectly or directly depend, previously recite a cup.
Claim 27 recites the limitation "the heat sinks" in l. 4. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 27 depends from claim 25, which incorporates the device of claim 1. The claim 1 device refers to “at least one heat sink”, referring to embodiments of the device with a single heat sink and embodiments of the device with more than one heat sink. Claim 27, however, refers to embodiments only in the plural “heat sinks”. Thus, it is not clear if claim 27 is referring back to the “at least one heat sink” in claim 1, or if it is intended to be limiting to only those devices that have more than one heat sink, or something else entirely.
Claims 28-29 depend from claim 27, and consequently incorporate the lack of
antecedent basis issues of claim 27.
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.
Claims 18 and 24 are 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 18 recites the limitation “wherein the cup is made of a material that is the same
or different from that of the at least one heat sink”. Since this limitation encompasses every embodiment of the cup, claim 18 does not further limit the claims from which it depends, and consequently is in improper dependent form.
Claim 24 recites that the device is “a point-of-care incubator for isothermal nucleic acid amplification tests”. Since this statement is merely describing a property of the claim 1 device and does not add any additional structural limitations to it, it does not further limit the claim 1 device, and consequently 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 § 102
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 1-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultz (A Portable Point-of-Care Device using Joule Heating and Latent Energy Storage for the Temperature Regulation of Isothermal Nucleic Acid Amplification Tests, Graduate Theses and Dissertations, University of Arkansas, 2021).
As noted above, the Schultz author appears to be the inventor in the instant case.
Schultz was apparently published on or before November 18, 2021 (see cover page attached to document). There is significant overlap between the description and figures in Schultz and the instant specification and figures, with some parts of Schultz and the instant specification being identical.
Regarding claims 1-5, 7-11, 20 and 23-24, Schultz teaches all of the limitations of all of these claims (see entire document; esp. Figs. 3.1-3.7, 4.1-4.9, 4.12-4.14, 4.16, 4.18-4.19, 4.22; Sections 1.1.1-1.1.13, 1.2-1.3, 3, 4).
Regarding claims 6, 12-19 and 21-22, as noted above, these claims are indefinite. Nevertheless, Schultz teaches at least some embodiments seemingly comprised in these claims (see entire document; esp. Figs. 3.1-3.7, 4.1-4.9, 4.12-4.14, 4.16, 4.18-4.19, 4.22; Sections 1.1.1-1.1.13, 1.2-1.3, 3, 4).
Claims 1-4, 6-20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erickson (WO 2018/191252 A1).
Regarding independent claim 1 and dependent claims 2, 4, 17, Erickson teaches …
A point-of-care (POC) device for isothermal nucleic acid amplification tests (NAAT), comprising: a housing, optionally thermally insulated (Figs. 1-4; paras. 8-11, 68, 74, 86);
a heater disposed in the housing, optionally in the bottom of the housing (Figs. 1-4; paras. 8-11, 68, 86);
at least one heat sink, optionally aluminum, disposed in the housing in thermal communications with the heater, and configured to speed up heating and hold reaction tubes containing the NAAT being incubated (Figs. 1-4; paras. 8-11, 68, 70, 77, 86, 94, 97);
and a phase change material (PCM) adapted for regulating temperature of the reactions (Figs. 1-4; paras. 8-11, 68, 86).
Regarding dependent claim 3, Erickson additionally teaches that the housing comprises an external insulated lid and an internal insulated plug. More specifically, Erickson teaches that the “temperature regulation component 120 further comprises an insulator 190 surrounding or enclosing … the second enclosure” (para. 74). Thus, the insulator that encloses the top of the device can be considered an external insulated lid. Further, Erickson teaches component 144 which is a plug configured to keep the phase change material within the designated space (para. 72). Since component 144 is also comprised within the second enclosure, and since the second enclosure is surrounded by an insulator, then the internal plug is an inernal insulated plug.
Regarding dependent claim 6, as noted above, this claim is indefinite. Nevertheless, Erickson teaches a gas-powered flame (para. 148), an external hot-plate (para. 147), and/or a cartridge heater (i.e., nichrome wire) (para. 150).
Regarding dependent claims 7-9, Erickson additionally teaches a power source for operably providing power to the heater (paras. 88, 103), as recited in claim 7, and that the power source is a battery, which is optionally rechargeable (para. 88), as recited in claims 8-9, respectively. Specifically, Erickson teaches that an iPhone 6S battery is used to heat the device. The ordinary artisan understands that an iPhone 6S battery is rechargeable.
Regarding dependent claims 10-11, Erickson additionally teaches that the device further comprises a cup placed inside the housing in such a way that the cup is suspended over the heater without making direct contact with the heater (Fig. 1: second enclosure 140), as recited in claim 10, that the cup is configured to hold the PCM, the reaction tubes, and the at least one heat sink (Fig. 1: 130, 150: Fig. 2), as recited in claim 11.
Regarding dependent claim 12, as noted above, claim 12 is indefinite. Nevertheless, Erickson teaches that the cup is configured to hold the least one heat sink such that it is partially submerged in the PCM (Fig. 1).
Regarding dependent claims 13-14, as noted above, claims 13-14 are indefinite. Nevertheless, Erickson additionally teaches that the at least one heat sink has center holes, and which seemingly have the recited configuration (Figs. 1-2), as recited in claim 13, and that the center holes are designed to hold the reaction tubes containing the NAAT (Figs. 1-2), as recited in claim 14.
Regarding dependent claim 15, as noted above, this claim is indefinite. Nevertheless, Erickson teaches a material which is a heat sink, and which seemingly would have the recited properties. Thus, claim 15 is rejected with the same reasoning as claim 1.
Regarding dependent claim 16, Erickson additionally teaches an interior lid placed inside the cup and an insulated lid placed over the opening of the housing during incubation. More specifically, Erickson teaches that the “temperature regulation component 120 further comprises an insulator 190 surrounding or enclosing … the second enclosure” (para. 74). Thus, the insulator that encloses the top of the device can be considered an insulated lid placed over the opening of the housing. The phrase “during incubation” is a statement of intended use. Since that intended use does not result in a structural difference between the claimed invention and the prior art, it does not further limit the claim. See MPEP 2112.02 (II). Further, Fig. 1 shows an absorption plate (180) that covers the cup and is partially recessed inside the cup. Thus, the absorption plate can be considered an interior lid placed inside the cup.
Regarding dependent claim 18, Erickson additionally teaches that the cup is made of a material that is the same as that of the at least one heat sink (para. 70: aluminum).
Regarding dependent claim 19, as noted above, this claim is indefinite. Nevertheless, Erickson teaches a PCM material which seemingly would have the recited properties. Thus, claim 19 is rejected with the same reasoning as claim 1.
Regarding dependent claims 20 and 22, Erickson teaches that the PCM is PureTemp-63 which has a melting temperature of 63°C, which can be used for LAMP, and which is close to the target reaction temperature of LAMP (paras. 20, 35, 72-73).
Regarding dependent claim 24, the phrase “being a point-of-care incubator for isothermal nucleic acid amplification tests” is a statement of intended use. Since that intended use does not result in a structural difference between the claimed invention and the prior art, it does not further limit the claim. See MPEP 2112.02 (II). Thus, claim 24 is rejected with the same reasoning as claim 1.
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 Erickson (WO 2018/191252 A1) in view of Anderson (US Patent App. Pub. No. 2002/0022261 A1).
Regarding dependent claim 5, Erickson teaches a device comprising a variety of types of
heating sources (e.g., para. 150), while Anderson specifically teaches a resistive heater of a thin-film polyimide heater (paras. 201-202).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to modify the Erickson device with the Anderson heater. The ordinary artisan would have been motivated to do so to customize the device as desired. Further, such heaters are known in the art as being useful in nucleic acid assay devices. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. MPEP 2144.07. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay devices is well-known in the art.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson (WO 2018/191252 A1) in view of Shen (CN 110079452 A; references below are to English machine translation of specification, attached) and Baker (US Patent App. Pub. No. 2011/0315783 A1).
Regarding dependent claim 21, Erickson teaches a device for performing isothermal
amplification comprising a phase change material adapted for regulating the temperature required for the corresponding isothermal amplification reaction. Erickson additionally teaches the particular “PureTemp” brand of phase change materials (Figs. 1-4; paras. 8-11, 68, 72-73, 86).
Shen teaches devices for performing RPA reactions, and teaches performing RPA reactions at 37°C-39°C (p. 1, para. 4; p. 1, bottom para.). Shen additionally teaches that the devices comprise a phase change material, and that the phase change material has a melting temperature that is consistent with the temperature required for the amplification reaction (p. 1, bottom para.; p. 2, para. 12).
Finally, Baker teaches PureTemp-37, with a melting temperature of about 37°C (para. 56).
Prior to the effective filing date of the instant invention, it would have been prima facie
obvious to modify the Erickson device with the teachings of Shen and Baker. The ordinary artisan would have been motivated to do so to customize the device as desired, e.g., to be compatible with use in an RPA reaction. Further, PureTemp PCMs are known in the art as being useful in nucleic acid assay devices. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. MPEP 2144.07. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay devices is well-known in the art.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson (WO 2018/191252 A1) in view of Velders (T-Cup: A Cheap, Rapid, and Simple Home Device for Isothermal Nucleic Acid Amplification, Global Challenges, 6(3): 2021).
Regarding dependent claim 23, Erickson teaches devices with electronic components,
e.g., printed circuit boards. However, Erickson teaches that these electronic components are only present in some embodiments (paras. 79, 85). Thus, since electronic components are optional, Erickson at least suggests devices without electronic components.
Velders teaches devices without electronic components (e.g., abstract; Figs. 1 and 3).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to combined the teachings of Erickson and Velders to arrive at a device without electronic components. The ordinary artisan would have been motivated to do so to achieve the expected advantage of a less expensive and easier to operate device (because such a device would have fewer components). The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay devices is well-known in the art.
Claims 25-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson (WO 2018/191252 A1) in view of O’Mahony (A real time PCR assay for the detection and quantitation of Mycobacterium avium subsp. paratuberculosis using SYBR Green and the Light Cycler, Journal of Microbiological Methods, 1, 283-293, 2002), as evidenced by Qiagen (DNeasy Blood & Tissue Kit – Quick-Start Protocol, 2016).
Regarding independent claim 25, Erickson teaches …
A method of POC detection of a disease in a subject, comprising: preparing bio-samples
of the subject (paras. 130-131);
incubating the bio-samples in the POC device of claim 1 (see citations for claim 1 above; also paras. 122-123);
and visually detecting the disease from the incubated bio-samples (paras. 122-123; Fig. 16).
O’Mahony teaches that the disease is Johne’s disease, which is caused by Mycobacterium avium subsp. paratuberculosis (e.g., abstract).
Regarding dependent claims 26-27 and 29, Erickson teaches or suggests that the method further comprises collecting the bio-samples from the subject (paras. 108, 130-131); cleaning and concentrating the bio-samples for DNA extraction (paras. 130-131: DNeasy Blood & Tissue kit; Qiagen teaches cleaning the samples on the spin column (e.g., step 4) and concentrating the samples by centrifugation (e.g., steps 4, 8)), determining suitable primers for the detecting the disease-causing agent (paras. 118-199; Table 3); and mixing the bio-samples and the primers for an isothermal amplification method, optionally LAMP reactions (paras. 116-121), as recited in claim 26. Erickson additionally teaches that the method further comprises heating the POC device to a target temperature, optionally 63°C (para. 141), and placing the bio-samples in the center of the heat sinks and incubating them for a period of time, optionally about 60 minutes (Figs. 1-2; para. 155: at least 50 minutes), to perform the isothermal amplification method, optionally LAMP (para. 141), as recited in claims 27 and 29.
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to modify the Erickson method with the O’Mahony target and to optimize the assay timing. Erickson teaches or suggests that the device and method can be used to detect a variety of infectious disease-causing agents, including bacteria and viruses, in the field or in low resource settings (e.g., paras. 5, 67). O’Mahony teaches that Johne’s disease is caused by the MAP bacteria, which is present in infected cattle and can also be found in pasteurized milk. The ordinary artisan would have been motivated to try detecting MAP from cattle in the field or in a milk processing facility using the Erickson method because Erickson teaches that the method is useful for detecting similar targets in such settings. The ordinary artisan would have been further motivated to customize the heating time of the assay to optimize the detection of the MAP target. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay devices is well-known in the art.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson (WO 2018/191252 A1) in view of O’Mahony (A real time PCR assay for the detection and quantitation of Mycobacterium avium subsp. paratuberculosis using SYBR Green and the Light Cycler, Journal of Microbiological Methods, 1, 283-293, 2002), as evidenced by Qiagen (DNeasy Blood & Tissue Kit – Quick-Start Protocol, 2016), as applied to claim 25 above, and further in view of Yu (WO 2017/214561 A1).
Regarding dependent claim 26, Erickson teaches or suggests that the method further comprises collecting the bio-samples from the subject (paras. 108, 130-131); cleaning and concentrating the bio-samples for DNA extraction (paras. 130-131: DNeasy Blood & Tissue kit; Qiagen teaches cleaning the samples on the spin column (e.g., step 4) and concentrating the samples by centrifugation (e.g., steps 4, 8)), determining suitable primers for the detecting the disease-causing agent (paras. 118-199; Table 3); and mixing the bio-samples and the primers for an isothermal amplification method.
Yu teaches that the isothermal amplification method is RPA (paras. 379-383).
Regarding dependent claim 27, Erickson additionally teaches that the method further comprises heating the POC device to a target temperature (para. 141), and placing the bio-samples in the center of the heat sinks and incubating them for a period of time (Figs. 1-2; para. 155: at least 50 minutes), to perform the isothermal amplification method (para. 141).
Yu teaches that the isothermal amplification method is RPA (paras. 379-383).
Regarding dependent claim 28, Yu teaches that the target temperature is about 37°C, and the period of time is about 30 min (para. 383).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to further modify the modified Erickson method, discussed above, with the Yu RPA method. Erickson teaches or suggests that the method can be used to detect a variety of infectious disease-causing agents in the field or in low resource settings using isothermal amplification techniques, optionally LAMP (e.g., paras. 5-6, 67). The ordinary artisan would have modified the Erickson method with RPA with motivation that doing so would result in the expected advantage of a more efficient method, as the RPA incubation time is lower than the LAMP incubation time (30 min vs. 60 min). The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay is well-known in the art.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson (WO 2018/191252 A1) in view of O’Mahony (A real time PCR assay for the detection and quantitation of Mycobacterium avium subsp. paratuberculosis using SYBR Green and the Light Cycler, Journal of Microbiological Methods, 1, 283-293, 2002), as applied to claim 25 above, and further in view of Zheng (RPA-SYBR Green I based instrument-free visual detection for pathogenic Yersinia enterocolitica in meat, Analytical Biochemistry, 621, 1-6, 2021), as evidenced by Rasmussen (Quantitative PCR by Continuous Fluorescence Monitoring of a Double Strand DNA Specific Binding Dye, Biochemica, 2, 8-11, 1998).
Regarding dependent claim 30, O’Mahony additionally teaches mixing an amount of SYBR Green with the incubated bio-samples to form a mixture thereof (Table 1; section 2.3). Further, O’Mahony cites Rasmussen for teachings related to SYBR Green (p. 284, left col., para. 4). Rasmussen, in turn, teaches that the specific SYBR Green is SYBR Green I (Rasmussen: p.8, para. 2). Finally, Zheng teaches illuminating the mixture with UV light at a wavelength of about 365 nm, and teaches that the resulting fluorescence can be observed visually (p. 2, left col., para. 2).
Regarding dependent claim 31, Zheng teaches that the bio-samples that are positive for the target fluoresce with more intensity than a negative control (Figs. 2-3).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to further modify the modified Erickson method, discussed above, to incorporate SYBR Green as the detectable label and to detect the SYBR Green, as taught in Zheng. Erickson teaches or suggests that the method can be used to detect a variety of infectious disease-causing agents in the field or in low resource settings using isothermal amplification techniques, optionally LAMP (e.g., paras. 5-6, 67). The ordinary artisan would have modified the Erickson method with a SYBR Green I and UV detection system with the expectation that doing so would result in the expected advantage of a more efficient method, as such a detection system generates light in a visible wavelength, thus omitting the need for a fluorescence detector, as in Erickson. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid assay is well-known in the art.
Conclusion
Claims 1-31 are being examined, and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
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