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 .
It is noted for the record that this Application has been transferred to Examiner Christine Jones in Art Unit 1628.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 5, 2026 has been entered.
Status of the Claims
It is acknowledged that Applicant amended claims 1 and 4 in the response filed June 5, 2026.
Claims 1 and 3-12 are currently pending and examined herein on their merits.
Summary of Response to Applicant’s Arguments
In the response filed June 5, 2026, Applicant amended claims 1 and 5 and provided arguments against the rejections under 35 U.S.C. 103. New and modified rejections to the amended claims are set forth below. The response to arguments is included on pages 12-13 of this office action.
Priority
This application claims the benefit of the filing date of Application No. 63/138,310 filed 01/15/2021 and claims benefit of Application No. 63/138,312 filed 01/15/2021 and claims benefit of Application No. 63/138,314 filed 01/15/2021 and claims benefit of Application No. 63/138,316 filed 01/15/2021 and claims benefit of Application No. 63/138,318 filed 01/15/2021 and claims benefit of Application No. 63/138,320 filed 01/15/2021 and claims benefit of Application No. 63/138,321 filed 01/15/2021 and claims benefit of Application No. 63/138,323 filed 01/15/2021 and claims benefit of Application No. 63/138,337 filed 01/15/2021 and claims benefit of Application No. 63/138,341 filed 01/15/2021. The priority date of claims 1 and 3-12 are considered to be 01/15/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In amended claims filed June 5, 2026, Applicant introduced amendment to claim 1 that requires that the claimed composition is substantially free of “ammonium salts, including ammonium sulfate, ammonium carbonate, and ammonium chloride” (underlined are the amendments). Although it is true that claim 4 of the originally filed claims gives support for the composition being substantially free of ammonium carbonate, there is no support for the composition being substantially free of ammonium chloride or substantially free of all ammonium salts. The specification allows that volatile compounds can be excluded because they may interfere with LAMP reactions when they leave behind reactive ions (par. 131), but does not clearly limit the term “volatile.” The definition given (“high vapor pressure or a low boiling point” – par. 82) uses relative terminology which encompasses a potentially vast range of compounds. The specification specifically links the interference of volatile agents with the effects of compounds such as ammonium sulfate or ammonium carbonate which affect the pH of the system by becoming sulfuric or carbonic acid and cause discoloration (par. 132, 162). However, it is unclear whether all ammonium salts (including quaternary ammonium salts) would have been deemed ‘volatile agents’ capable of imparting undesired effects on the composition. Therefore, although the originally filed disclosure provides support for the exclusion of the genus ‘volatile agents’ and particular species of said genus (“ammonium carbonate” and “ammonium sulfate”), it does not provide support for the genus ‘all ammonium salts’ or the species ‘ammonium chloride.’
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 1 and 3-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 3-12 are rejected for the recitation of “non-interfering LAMP reagents” in claims 1 and 3-5 as indefinite. Neither the claims nor the specification give a clear, limiting definition of the term. The specification describes a “pH-interfering reagent” as one which affects the pH of a system for reasons other than amplification from a LAMP reaction (par. 85). However, it is not clear whether the ‘non-interfering LAMP reagents’ are meant to correspond to ‘non-pH-interfering LAMP reagents’ or whether they’re meant to include other types of non-interfering reagents (i.e. those which do not interfere with polymerase function, etc.). Furthermore, it is unclear what is encompassed by ‘affecting’ the pH of a system for reasons other than LAMP amplification. For example, would incidental storage buffer of a polymerase added to a master mix qualify as affecting the pH of the system for reasons other than LAMP amplification? As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claims 1 and 3-12 are rejected for the recitation of “a plurality of non-interfering LAMP reagents” in claims 1 and 3-5 as indefinite. It is unclear whether the ‘plurality’ recited includes the additionally recited elements of the composition. For example, for claims 3 and 4, must the claimed composition as a whole be substantially free of volatile reagents and magnesium, or would the claims allow those elements to be comprised in distinct sections of the composition (i.e. a composition in the form of a kit comprising the ‘plurality of non-interfering LAMP reagents’ in one container and magnesium in another)? As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claim 3 is rejected for the recitation of “substantially free of volatile reagents, pH-interfering reagents, and magnesium-interfering reagents” as indefinite. In the specification, there is no definition of ‘magnesium-interfering reagents,’ and ‘volatile reagents’/’pH-interfering reagents’ are discussed but defined using relative terms (par. 84-85). It is unclear what the threshold for determining a high vapor pressure or low boiling point would be, to classify an agent as volatile. It is unclear what is encompassed by ‘affecting’ the pH of a system. And it is unclear what is encompassed by magnesium-interfering. For example, would a magnesium- and pH-sensitive dye such as hydroxy napthol blue be considered a magnesium-interfering reagent? As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-5, and 7-11 are rejected under 35 U.S.C. 103 as unpatentable over Diego et al. (published Oct 14, 2019; García-Bernalt Diego et al. Sci Rep. 2019 Oct 14;9(1):14744; provided as NPL #6 in IDS filed July 13, 2026) in view of Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493).
Regarding claim 1, Diego teaches compositions for loop-mediated isothermal amplification (LAMP) analysis utilizing a pH-dependent output signal comprising a pH sensitive dye (‘hydroxyl-napthol blue’), a plurality of LAMP reagents which are substantially free of ammonium sulfate (pg. 3: Stabilization procedures…), and betaine (pg. 3, 1st full par.).
Here, Diego teaches multiple compositions. The ‘two-step dry-up (S1.1a)’ composition, for example, has multiple forms or stages. The first stage requires only primers and dye dried in the presence of trehalose and glycerol. In the second stage, Bst polymerase and dNTPs are added and dried for a second time. For clarity, the compositions relied on in this rejection are the first and second stage compositions of Diego. In the first stage, the plurality of LAMP reagents can be considered the primers (and betaine/trehalose). In the second stage, the plurality of LAMP reagents may be considered as the primers, the polymerase, the dNTPs, etc.
After the second drying, the final reaction requires the addition of reagents including buffer and magnesium sulfate. This buffer (‘Isothermal Amplification Buffer 1X’; pg. 2, last par. – pg. 3, 2nd par.) likely includes ammonium compounds. However, regarding the first and second stage compositions (which may be stored long term), Diego is silent regarding the addition of ammonium-containing compounds. Diego only positively recites their potential addition as added to the final reaction composition. Therefore, the limitation that the plurality of LAMP reagents be substantially free of “ammonium salts, including ammonium sulfate, ammonium carbonate, and ammonium chloride” is considered to have been met.
Regarding the limitation that the reagents be “non-interfering LAMP reagents,” the term is not given a limiting definition in the specification, and is thus interpreted according to its plain meaning in a chemistry context: an element or substance other than the analyte of interest which may cause false or skewed results. Diego is silent regarding the addition of reagents which may skew results, and includes a negative control to assess the presence of false positives (Figure 2). Therefore, Diego is considered to have anticipated the limitation that reagents should be a plurality of “non-interfering” LAMP reagents.
Regarding claim 1, Diego does not explicitly teach pH sensitive dyes being at least one of phenol red, phenolphthalein, azolitmin, bromothymol blue, naphtholphthalein, cresol red, or combinations thereof. Diego instead teaches the colorimetric/fluorometric indicator CFI, which is a mix of hydroxy naphtol blue and GelGreen (pg. 3, 2nd full par.).
Tanner teaches LAMP compositions which utilize a pH sensitive dye in the form of phenol red, phenolphthalein, or cresol red (col. 2, ln. 10-17).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to substitute CFI for phenol red, phenolphthalein, or cresol red because these compounds are used for the same purpose (i.e. they’re colorimetric indicators for LAMP reactions) and therefore they may be considered functional equivalents. One would have had reasonable expectation of success because Tanner demonstrates the use of at least phenol red in LAMP assays (Fig. 1).
Regarding claim 3, Diego teaches drying the composition, which would result in the absence of volatile compounds. Therefore, Diego is considered to have met the limitation that the plurality of reagents be substantially free of volatile reagents. Diego does not explicitly teach that the reagents are substantially free of pH-interfering reagents or magnesium-interfering reagents. However, the dye used by Diego includes hydroxy naphthol blue, which is sensitive to pH-interfering reagents or magnesium-interfering reagents. Therefore, the fact that Diego’s assays demonstrate positive signal in samples/positive controls and no signal in negative controls is considered to demonstrate that the composition taught by Diego is substantially free of such reagents.
Regarding claim 4, Diego is silent regarding the addition of magnesium to the first and second stage compositions and only positively recites their potential addition as added to the final reaction composition. Therefore, the limitation that the plurality of LAMP reagents be substantially free of magnesium is considered to have been met.
Regarding claim 5, Diego teaches that the LAMP reagents comprise DNA polymerase and target primers (pg. 2, last par.; pg. 3: Stabilization procedures…).
Regarding claim 7, Diego does not teach that the composition further comprises carrier RNA, carrier DNA, RNAase inhibitors, DNAase inhibitors, guanidine hydrochloride, or combinations thereof.
Tanner teaches the addition of guanidine salts to LAMP reactions (col. 26, ln. 31-41), including guanidine hydrochloride (col. 13, ln. 1-5) and the addition of RNase inhibitors (col. 16, ln. 39-48).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Diego and Tanner. One would have been motivated to do so in order to improve reaction sensitivity (col. 16, ln. 39-48; col. 26, ln. 31-41). One would have reasonable expectation of success because the principles of RNase inhibition and guanidine hydrochloride addition are routine and Tanner states that they are applicable to LAMP and a wide variety of non-LAMP nucleic acid assays (col. 16, ln. 34 – col. 17, ln. 20).
Regarding claim 8, Diego does not teach that the LAMP analysis is reverse transcription LAMP.
Tanner teaches reverse-transcription LAMP (col. 1, ln. 49-59; col. 2, ln. 47-50).
It would have been obvious before the effective filing date of the instant invention to combine the teachings of Diego and Tanner. One would have been motivated to do so in order to detect infectious agents such as SARS-CoV-2 as part of surveillance efforts (col. 1: Background). One would have had reasonable expectation of success because Tanner focuses on and demonstrates functional RT-LAMP (Fig. 1).
Regarding claim 9, Diego teaches that the composition comprises a solid phase medium in the form of a dried (solid) pellet. The instant application allows that a solid phase medium refers to “a non-liquid medium, device, system, or environment” (par. 81) and therefore Diego is considered to have met the limitation.
Regarding claims 10 and 11, Diego teaches that the composition further comprises a non-discoloration additive comprising a sugar in the form of trehalose (pg. 3, 2nd full par.). The instant application’s specification provides a non-limiting definition of “non-discoloration additives” as additives that minimize or prevent a color change in the color of the solid phase medium from an original or starting color to a different color for reasons other than nucleotide amplification from a LAMP reaction taking place thereon or therein (par. 82). Although Diego does not describe the sugar explicitly as a “non-discoloration additive,” it does provide that the trehalose possibly lowers polymerase amplification efficiency (pg. 6, par. 1), and results in a delay in the appearance of positive results and reduction in detectable signal (pg. 6, par. 3). As colorimetric signal is the output of Diego’s system, the limitation is considered to have been met.
Claim 6 is rejected under 35 U.S.C. 103 as unpatentable over Diego et al. (published Oct 14, 2019; García-Bernalt Diego et al. Sci Rep. 2019 Oct 14;9(1):14744; provided as NPL #6 in IDS filed July 13, 2026) in view of Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493), as applied to claim 6 above, and further in view of Lee et al. (published December 12, 2017; Patent Application Publication US 20150361511).
Diego and Tanner teach the limitations of claim 1, as discussed above.
Regarding claim 6, Diego and Tanner do not explicitly teach that the composition further comprises an antioxidant. However, Diego does teach that oxidation of LAMP reagent compositions may disrupt the three-dimensional structure of polymerase and cause the loss of function (pg. 8, 2nd par.).
Lee teaches the addition of antioxidants (par. 35) to freeze-dried nucleic acid amplification compositions (Abstract; par. 23).
It would have been obvious to combine the teachings of Diego and Tanner with the teachings of Lee. One would have been motivated to do so in order to stabilize the mixture (par. 35). One would have had reasonable expectation of success because Lee specifically contemplates the enzyme composition as it relates to LAMP (par. 23), and because the freeze-dried compositions of Lee are similar in oxidative vulnerability to the dried compositions of Diego.
Claim 12 is rejected under 35 U.S.C. 103 as unpatentable over Diego et al. (published Oct 14, 2019; García-Bernalt Diego et al. Sci Rep. 2019 Oct 14;9(1):14744; provided as NPL #6 in IDS filed July 13, 2026) in view of Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493), as applied to claim 1 above, and further in view of Liang et al. (published July 18, 2019; Patent Publication No. US 2019/0218604).
Diego and Tanner teach the limitations of claim 1, as discussed above.
Regarding claim 12, Diego and Tanner do not teach that the composition further comprises a blocking agent comprising bovine serum albumin, casein, or combinations thereof.
Liang teaches additive compositions for use in LAMP reactions, including dextran and/or bovine serum albumin or “BSA” (par. 82).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Diego and Tanner with the teachings of Liang, in order to incorporate reagents into the LAMP reaction composition which enhance LAMP reactions (par. 82) by reducing the threshold time for positive samples (par. 85). One would have had reasonable expectation of success because Liang demonstrates the successful addition of BSA to LAMP (par. 53).
Response to Arguments
In the response filed June 5, 2026, Applicant argued that Tanner remained deficient for the reasons discussed in their previous remarks (filed August 25, 2025), and that Lemura both fails to supply the needed elements and teaches against the instant invention by reciting the use of ammonium-containing compounds including ammonium chloride. Applicant further argued that the ammonium-containing formulation of Lamura would result in undesired color change which would undermine the operation of Applicant’s claimed pH dependent composition.
These arguments have been fully considered and are not found to be fully persuasive. Among other considerations, Lamura teaches the use of guanidine hydrochloride (col. 5, 2nd to last par.). Guanidine hydrochloride is not excluded from the claimed instant composition (claim 7) and appears to result in a functional composition (see Examples 7 and 16 of the instant specification, for example). Although Lamura describes it as an ‘quaternary ammonium salt,’ guanidine hydrochloride is a hydrochloride salt of guanidine, while ammonium salts are ionic compounds composed of ammonium ions (NH4+) and acid radical ions, generally obtained through the reaction of ammonia and acid. Therefore, while guanidine hydrochloride is related to ammonium salts, it is not itself an ammonium salt. Furthermore, the originally filed disclosure of the instant application does not provide support for the amendment filed June 5, 2026 requiring the exclusion of all ammonium salts, including ammonium chloride. For the purposes of compact prosecution, however, the limitations of the amended claims have been addressed by the new rejections set forth above (which do not rely on Lamura).
The deficiencies of Tanner, as set forth in the response filed August 25, 2025, were addressed in the final office action mailed April 6, 2026. Since the Applicant has not set forth further arguments regarding the deficiencies of Tanner, and because this office action relies on a different combination of references, those arguments are considered moot.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 17/576,971, in view of Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493).
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims are drawn to compositions for loop-mediated isothermal amplification analysis. Both sets of claims require:
A plurality of non-interfering LAMP reagents (claims 1, 3, 4)
Betaine (claim 1)
That the reagents be substantially free from ammonium-containing compounds such as ammonium sulfate (claim 1, 3)
Colorimetric dyes (ref claim 1)
Although the reference does not explicitly require the claimed pH sensitive dyes, it would be obvious to one with ordinary skill in the art to use dyes such as phenol red, phenolphthalein, or cresol red which are known for the purpose of providing colorimetric signal (Tanner: col. 2, ln. 10-17) and which are pH sensitive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 17/576,975, in view of Diego et al. (published Oct 14, 2019; García-Bernalt Diego et al. Sci Rep. 2019 Oct 14;9(1):14744; provided as NPL #6 in IDS filed July 13, 2026)
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims are drawn to loop-mediated isothermal amplification analysis. Both sets of claims require:
A plurality of non-interfering LAMP reagents (claims 1, 30)
That the reagents be substantially free from ammonium-containing compounds such as ammonium sulfate (claims 1, 30)
pH sensitive dyes such as phenol red, phenolphthalein, azolitmin, bromothymol blue, naphtholphthalein, cresol red, or combinations thereof (claim 28, 29)
Although the reference does not explicitly require the presence of betaine, it would be obvious to include betaine for example to prevent secondary structure formation in GC-rich regions (Diego: pg. 4, 1st par.). Although the reference claims are directed to a medium and a method, the method recites the use of reagents and it would be obvious to modify to recite the reagents as a composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 17/576,976, in view of Diego et al. (published Oct 14, 2019; García-Bernalt Diego et al. Sci Rep. 2019 Oct 14;9(1):14744; provided as NPL #6 in IDS filed July 13, 2026) and Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493).
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims are drawn to loop-mediated isothermal amplification analysis. Both sets of claims require:
A plurality of non-interfering LAMP reagents (claims 1, 4)
That the reagents be substantially free from ammonium-containing compounds such as ammonium sulfate (claims 1)
pH sensitive dyes (claim 14, 17)
Although the reference does not explicitly require the presence of betaine, it would be obvious to include betaine for example to prevent secondary structure formation in GC-rich regions (Diego: pg. 4, 1st par.). Although the reference does not explicitly require the presence of betaine, it would be obvious to include betaine for example to prevent secondary structure formation in GC-rich regions (Diego: pg. 4, 1st par.). Although the reference claims are directed to an apparatus and a method, the method and apparatus recite the use of reagents and it would be obvious to modify to recite the reagents as a composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine M Jones whose telephone number is (571)272-2585. The examiner can normally be reached Monday - Friday, 8AM - 4PM.
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, Wu-Cheng Shen can be reached at (571)272-3157. 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.
/C.M.J./Examiner, Art Unit 1682
/WU CHENG W SHEN/ Supervisory Patent Examiner, Art Unit 1682
Prosecution Insights