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.
Response to Amendment
This action is in response to the papers filed August 25, 2025. Applicant's remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicant's amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
It is acknowledged that Applicant cancelled claims 2 and 13-22 in the response filed August 25, 2025.
Claims 1 and 3-12 are currently pending.
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 § 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).
Claim(s) 1 and 3-10 are rejected under 35 U.S.C. 103 as unpatentable over Lamura et al. (published Oct. 18, 2016; U.S. Patent No. 9,469,870), and in view of Tanner et al. (effectively filed July 24, 2020; U.S. Patent No. 10,968,493).
Regarding claim 1, Lamura teaches compositions for loop-mediated isothermal amplification (LAMP) analysis utilizing a pH-dependent output signal (col 2, ln 41-43) comprising a pH sensitive dye (col 2, ln 56-58), a plurality of LAMP reagents which are substantially free of ammonium sulfate (col. 7, ln. 40), and betaine (col. 7, ln 36). 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. Lamura explicitly teaches reagents which do not mask the production of protons during amplification (col. 3, ln. 36-61). Therefore, Lamura is considered to have anticipated the limitation that reagents should be a plurality of “non-interfering” LAMP reagents.
While Lamura does teach that the pH sensitive dye may be colorimetric, Lamura does not teach that the pH sensitive dye is at least one of phenol red, phenolphthalein, azolitmin, bromothymol blue, naphtholphthalein, cresol red, or combinations thereof.
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 combine the teachings of Lamura and Tanner. One would have been motivated to do so in order to use a pH-sensitive dye which changes color visually to indicate amplification has occurred (col. 2, ln. 4-17). This would be desirable, for example, in field applications (col. 15, ln. 39-43) which may require visualization under ambient lighting conditions.
Regarding claims 3 and 4, Lamura teaches that the reagents are substantially free of pH-interfering reagents (col. 3, ln. 36-61; col.6, ln. 42-46), and that the reagents are substantially free of ammonium carbonate (col. 7, ln 35-44).
In instant specification a non-limiting definition of “substantially free” is given which includes situations where a composition can “so nearly completely lack particles that the effect would be the same as if it completely lacked particles.” Regarding pH-interfering reagents, the specification provides that a “pH-interfering reagent” is a reagent that can affect the pH of a system for reasons other than amplification. Given this definition, the limitation that the composition is substantially free of pH-interfering reagents is considered to be met by Lamura (col. 3, ln. 36-61; col.6, ln. 42-46). Regarding ammonium carbonate, there is no obvious reason that ammonium carbonate would be present in the LAMP composition given the recited reagents, and no evidence that any traces of ammonium carbonate affect the composition. It is therefore the assertion of the examiner that the composition taught by Lamura (which is silent regarding the amount of ammonium carbonate) is substantially identical to the claimed composition comprising reagents being “substantially free of” ammonium carbonate. The burden of proof is therefore on the applicant to show that the reference’s composition does not meet the limitations – see MPEP 2112(V).
Regarding claim 5, Lamura teaches that the LAMP reagents comprise DNA polymerase (col. 7, ln. 35), reverse transcriptase (col. 8, ln. 55), target primers (col. 7, ln. 37), or combinations thereof.
Regarding claim 6, Lamura does not teach that the composition comprises an antioxidant.
Tanner teaches compositions comprising antioxidant (col. 25, ln. 14-20). In this case, the antioxidant is referred to a as a reducing agent.
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 Lamura and Tanner. One would have been motivated to do so in order to improve the sensitivity of the assay (col. 16, ln. 39-41; col. 17, ln. 27-31) and/or to provide nucleic acid for direct amplification (col. 25, ln. 18-20).
Regarding claim 7, Lamura teaches that the composition further comprises guanidine hydrochloride (col. 5, ln 58-65).
Regarding claim 8, Lamura teaches that the LAMP analysis is reverse transcription LAMP (col. 8, ln. 54-59).
Regarding claim 9, Lamura does not teach that the composition comprises a solid phase medium.
Tanner teaches that the composition comprises a solid phase medium (col. 25, ln. 60-63).
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 Lamura and Tanner to incorporate the LAMP composition onto a solid phase medium. One would have been motivated to do so in order to visualize amplification on a reaction matrix for rapid, field applications (col. 15, ln. 39-43).
Regarding claim 10, Lamura teaches that the composition further comprises a non-discoloration additive comprising a buffer (col. 7, ln. 35-44). 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 Lamura does not describe the buffers explicitly as “non-discoloration additives,” it does provide that the buffering agents reduce background noise - in this case, colorimetric signal (col. 2, ln. 56-58) resulting from sources other than amplification (col. 11, ln. 13-25). Therefore, the limitation is considered to have been met by the reference.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as unpatentable over Lamura et al. (published Oct. 18, 2016; U.S. Patent No. 9,469,870) 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).
Lamura and Tanner teach the limitations of claim 1, as discussed above.
Regarding claims 11 and 12, Lamura does not teach that the composition further comprises a sugar comprising one or more of trehalose, glucose, sucrose, dextran, or combinations thereof; nor that the composition comprises a blocking agent comprising bovine serum albumin, casein, or combinations thereof. Tanner teaches the use of trehalose in the composition (col. 39, ln 4) but does not suggest a motivation for its use in the composition.
Liang teaches additive compositions for use in LAMP reactions, including dextran and/or bovine serum albumin (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 Lamura 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).
Response to Arguments
In the response filed August 25, 2025, Applicant traversed the rejection under 35 U.S.C. 102(a)(2) based on Tanner et al. In the response, Applicant argues that a section of Tanner used to reject claim 4 does not disclose the limitation “substantially free of magnesium, ammonium sulfate, or ammonium carbonate,” and that Tanner as a whole does not disclose the terms “substantially free,” “free from,” or “ammonium sulfate.” The Applicant argues that given Tanner’s silence regarding these terms, Tanner can neither anticipate nor obviate those elements and the rejections of claims 1-11 should be withdrawn.
In the response, the Applicant amended claim 1 to include elements from claim 4 and the specification. These amendments have been considered as they relate to the rejections in the Non-Final dated June 2, 2025.
Regarding the argument that the rejections should be withdrawn due to Tanner’s silence about the limitations of claim 4, the argument has been fully considered. It is noted for the record that the amended claims are now being rejected over a new combination of references. The new primary reference is being relied upon to teach a composition for LAMP that is free of ammonium sulfate. Since the Applicant’s amendments necessitated these new grounds of rejection, this action is considered final.
In the response, the Applicant argues that as Tanner does not anticipate all elements of claim 1, it also cannot obviate claim 12. Applicant argues that claim 12 is allowable because the claim on which it depends is allowable (given the arguments and amendments regarding claim 1).
These arguments have been fully considered but are not persuasive. Under the new grounds of rejection necessitated by Applicant’s amendments, neither claim 1 nor claim 12 are allowable. See the updated rejection above for more detail discussing the unpatentability of said claims.
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
/AMANDA HANEY/Primary Examiner, Art Unit 1682