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 .
Upon further consideration of the inventors’ co-pending applications, the Non-Final Office action dated 07/17/2025 is hereby vacated. This Non-Final Office action replaces the Non-Final Office action dated 07/17/2025.
DETAILED ACTION
Priority
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION Priority This application claims the benefit of United States Provisional Patent Application Serial No. 63/138,310 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,312 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,314 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,316 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,318 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,320 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,321 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,323 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,337 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/138,341 filed January 15, 2021, United States Provisional Patent Application Serial No. 63/148,527 filed February 11, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 10/17/2025 is acknowledged. Claims 1-22 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) are being considered by the Examiner.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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.
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Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a system for chromatic loop-mediated isothermal amplification (LAMP) analysis comprising: a substantially non-reactive solid phase reaction medium; and a non-interfering reagent mixture.
Claims 1, 4, 6-9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-12 and 21-24 of copending Application No. 17/576,975.
Regarding instant claims 1, 4, 6-8, claim 1 recites a system for a chromatic loop-mediated isothermal amplification (LAMP) analysis comprising: a substantially non-reactive solid phase reaction medium; and a non-interfering reagent mixture; claim 4 recites the substantially non-reactive solid phase reaction medium comprises cellulose or glass fiber; claim 6 recites wherein the solid phase reaction medium is substantially free of oxidizing agents and pH-interfering agents; claim 7 further recites the system of claim 1, further comprising: an adhesive; a spreading layer; a spacer; and a plastic carrier are substantially free of oxidizing agents and pH-interfering agents; claim 8 recites wherein the non-interfering reagent mixture further comprises one or more target primers, DNA polymerase, and a re-solubilization agent. Claim 1 of ‘975 recites a solid phase LAMP reaction medium comprising: a substrate; an adhesive layer disposed on the substrate; a reaction layer disposed on the adhesive layer; and a spreading layer disposed on the reaction layer; wherein the spreading layer has uniform or graded porosity; claim 2 recites wherein the substrate is an optically transparent material; claim 3 recites wherein the adhesive layer is substantially free of volatile agents; claim 9 recites comprises reagents selected from one or more target primers, DNA polymerase, and are-solubilizing agent; claim 10 recites the reagents form a composition sufficient to carry out a LAMP reaction; claim 11 recites wherein the spreading layer further comprises at least one of glass fiber, cellulose, hydrophilic polytetrafluoroethylene; claim 12 recites wherein the spreading layer is optically transparent; and claim 21 recites the substrate is an optically clear plastic carrier. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 9 and 11, claim 9 recites a method of maximizing accuracy of a chromatic output signal in a solid phase pH-dependent loop-mediated isothermal amplification (LAMP) analysis comprising: providing a soldi phase reaction medium that minimizes non-LAMP reaction produced discoloration; and performing the LAMP analysis on the solid phase reaction medium; claim 11 recites controlling non-LAMP reaction produced discoloration using a non-discoloration additive; and claim 19 recites combining the reagent mixture with a non-reactive solid-phase reaction medium. As it pertains to claims 22-24 of ‘975, claim 22 recites a method of testing for a presence of a viral pathogen comprising: providing a saliva sample from a subject; and dispensing the sample into a test environment having a solid phase reaction medium in combination with a LAMP reagent mixture and a pH sensitive dye; claim 23 recites further comprising: minimizing the amount of volatile agents, hygroscopic agents, and non-pH sensitive agents capable of discoloring the solid phase medium; claim 24 recites providing an amount of one or more target primers, DNA polymerase, and a resolubilization agent sufficient to facilitate a LAMP reaction. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-5 of copending Application No. 17/576,976.
Regarding instant claims 9 and 11, claim 9 recites a method of maximizing accuracy of a chromatic output signal in a solid phase pH-dependent loop-mediated isothermal amplification (LAMP) analysis comprising: providing a soldi phase reaction medium that minimizes non-LAMP reaction produced discoloration; and performing the LAMP analysis on the solid phase reaction medium; claim 11 recites the method of claim 9, further comprising: controlling non-LAMP reaction produced discoloration using a non-discoloration additive.
Claim 1 of ‘976 recites a method of testing for a presence of a target nucleotide sequence comprising: providing a biological sample; and dispensing the biological sample into a test environment, comprising: a solid phase reaction medium in combination with a hygrosopic agent free loop-mediated isothermal amplification (LAMP) reagent mixture and a dehydrated pH sensitive dye; wherein the dispensed biological sample hydrates the solid phase reaction medium; claim 4 recites the method of claim 1, wherein the test environment is substantially free of volatile reagents, pH-affecting reagents, drying agents, or combinations thereof; claim 5 recites the method of claim 1, further comprising: providing a solid phase reaction medium comprising cellulose or glass fiber (it is noted that ‘974 defines solid phase reaction medium comprising cellulose or glass fiber). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 1-7, 9, 11-22 and are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8-12, 17 and 26-34 of copending Application No. 17/576,973.
Regarding instant claims 1-3, 4-7 and 14-18, claim 1 recites a system for a chromatic loop-mediated isothermal amplification (LAMP) analysis comprising: a substantially non-reactive solid phase reaction medium; and a non-interfering reagent mixture; claim 2 recites solid phase reaction medium has a buffering capacity from about 0.01 mM to about 5 mM; claim 3 recites solid phase reaction medium has a Amax ranging from about 443 nm to about 570 nm; claim 4 recites the substantially non-reactive solid phase reaction medium comprises cellulose or glass fiber; claim 5 recites wherein the substantially non-reactive solid phase reaction medium is hydrophilic, absorbent, and porous; claim 6 recites wherein the solid phase reaction medium is substantially free of oxidizing agents and pH-interfering agents; claim 7 further recites the system of claim 1, further comprising: an adhesive; a spreading layer; a spacer; and a plastic carrier are substantially free of oxidizing agents and pH-interfering agents; claim 14 recites wherein the non-discoloration additive comprises a blocking agent comprising bovine serum albumin, casein or combinations thereof; claim 15 recites a method of maximizing a level of detection (LOD) in a loop-mediated isothermal amplification (LAMP) analysis comprising: providing a reaction environment and reagents that minimize non-LAMP reaction products; claim 16 recites a system for a chromatic loop-mediated isothermal amplification (LAMP) analysis comprising: a combination of a solid phase reaction medium and LAMP reagents which when stored at 25°C maintain a coloration of the solid phase reaction medium that is within 10% of an initial shade of the solid phase medium; claim 17 recites the system of claim 16, wherein the combination maintains the coloration when stored for longer than one or more of: 30 days, 90 days, 365 days, 2 years, or 5 years; claim 18 recites wherein the combination maintains the coloration when stored at a relative humidity between about 40% and 90% at 25°C.
As it pertain to claims 1, 4-5, 8-12, 17, 26-31 of ‘973, claim 1 recites a loop-mediated isothermal amplification (LAMP) reaction assembly comprising: a solid-phase reaction medium, wherein the solid phase reaction medium comprises: a substrate, a reaction layer disposed on the substrate, and a LAMP reagent mixture combined with the reaction layer; wherein the LAMP reagent mixture contains potassium chloride and does not contain glycerol, ethanol, methanol, calcium chloride, or calcium sulfate; claim 4 recites wherein the solid-phase medium is hydrophilic, absorbent, and porous; claim 5 recites the solid-phase medium is a cellulose-based medium; claim 8 recites wherein the solid-phase medium comprises paper; claim 9 recites the solid-phase medium comprises glass fiber; claim 10 recites The LAMP reaction assembly of claim 1, wherein the solid-phase medium comprises nylon, polysulfone, polyethersulfone, cellulose acetate, nitrocellulose, or hydrophilic polytetrafluoroethylene (PTFE), or combinations thereof; claim 11 recites wherein the reaction layer is bonded to the substrate by an adhesive that is free of magnesium-interfering agents and hygroscopic agents; claim 12 recites a spreading layer that is less hydrophilic than the solid-phase reaction medium; claim 17 recites wherein the non-discoloration additive comprises a blocking agent comprising bovine serum albumin, casein, or combinations thereof; claim 26 recites the solid phase reaction medium has a buffering capacity from about 0.01 mM to about 5 mM; claim 27 recites the solid phase reaction medium has an Amax ranging from about 443 nm to about 570nm; claim 28 recites The LAMP reaction assembly according to claim 25, further comprising: an adhesive; a spreading layer; a spacer; and, wherein the substrate is a plastic carrier; and, wherein each of the adhesive, spreading layer, spacer, and plastic carrier are free of oxidizing agents and pH-interfering agents; claim 29 recites The LAMP reaction assembly of claim 25 further comprising: a combination of a solid phase reaction medium and lamp reagents when stored at 25°C maintain a coloration of the solid phase reaction medium that is within 10% of an initial shade of the solid phase medium; claim 30 recites wherein the combination maintains the coloration when stored for longer than one or more of 30 days, 90 days, 365 days, 2 years , or 5 years; claim 31 recites wherein the combination maintains the coloration when stored at a relative humidity between about 40% and 90% at 25°C. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 9, 11-13 and 19-22, instant claim 9 recites a method of maximizing accuracy of a chromatic output signal in a solid phase pH-dependent LAMP analysis comprising: providing a solid phase reaction medium that minimizes non-LAMP reaction produced discoloration; and performing the LAMP analysis on the solid phase reaction medium; claim 11 recites the method of claim 9, further comprising controlling non-LAMP reaction produced discoloration using a non-discoloration additive; claim 12 recites wherein the non-discoloration additive comprises a sugar, a buffer, a blocking agent, or combinations thereof; claim 13 recites wherein the non-discoloration additive comprises a sugar comprising one or more of trehalose, glucose, sucrose, dextran, or combinations thereof; claim 19 recites a method for manufacturing a chromatic LAMP system as recited in claim 1, comprising: combining the non-interfering reagent mixture with a substantially non-reactive solid-phase reaction medium such that the non-interfering reagent mixture is held in contact with the substantially non-reactive solid-phase reaction medium; wherein the manufacturing process comprises: preparing a solution containing the non-interfering reagent mixture; and coating the reagent mixture onto the substantially non-reactive solid-phase reaction medium; claim 21 recites wherein the coating comprises dropping, spraying, dipping, soaking, or misting the solution onto the substantially nonreactive solid phase reaction medium; and claim 22 recites wherein the non-interfering reagent mixture is combined with the substantially non-reactive solid-phase reaction medium using a reel-to-reel (R2R) process
As it pertain to claims 13-16 and 32-34 of ‘973, claim 13 recites a method of manufacturing a LAMP reaction assembly as recited in claim 1, comprising: combining the LAMP reagent mixture with the reaction layer of the solid-phase reaction medium such that the reagent mixture is held in contact with the solid-phase reaction medium; claim 14 recites controlling discoloration using a non-discoloration additive; claim 15 recites wherein the non-discoloration additive comprises a sugar, a buffer, a blocking agent, or combinations thereof; claim 16 recites wherein the non-discoloration additive comprises a sugar comprising one or more of trehalose, glucose, sucrose, dextran, or combinations thereof. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another; claim 32 recites The method of claim 13 wherein the manufacturing process comprises: preparing a solution containing the LAMP reagent mixture; and, coating the solution onto the reaction layer; claim 33 recites wherein the coating comprises dropping, spraying, dipping, soaking, or misting the solution onto the reaction layer; and claim 34 recites wherein the LAMP reagent mixture is combined with the substantially non-reactive solid-phase reaction medium using a reel-to-reel (R2R) process. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672