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 .
Priority
This application 17/506,804 filed on 10/21/2021 claims the benefit of Chinese Patent Application No. 202011137316.7, filed on October 22, 2020; and Japanese Patent Application No. 2021-170123, filed on October 18, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. It is noted that foreign priority is not perfected as no English translation was provided for the foreign priority documents received on 11/22/2021 (Chinese Patent Application No. 202011137316.7) and 11/24/2021 (Japanese Patent Application No. 2021-170123). In order to perfect the foreign priority claim, please provide a certified English copy.
In the absence of a translated copy, the priority date of claim 1 and its dependents is determined to be 10/21/2021, the filing date of the instant application.
Status of Claims
Applicant’s amendments to claims filed 09/02/2025 in response to the Non-Final Rejection mailed 06/02/2025 are acknowledged.
Claims 1, 3-6, 9-16 and 18 are amended.
Claim 2 has been canceled.
Claims 1 and 3-22 are pending and claims 1 and 3-17 are under examination.
Response to Remarks filed 09/02/2025
The amendments and arguments presented in the papers filed 09/02/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 06/02/2025 listed below have been reconsidered as indicated.
a) The objections to claims 12, 15 and 16 regarding informalities are withdrawn in view of the amendments to the claims.
b) The 35 USC 112(b) indefiniteness rejections of claims 13-15 have been withdrawn in view of the amendments to claims 13 and 14.
c) Rejections of claim(s) 1-6, 9, and 11-17 under 35 U.S.C. 102(a)(1) as being anticipated by Broughton et al. (WO2020257356), are withdrawn in view of the amendments to the claims
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Specification - maintained
The use of terms which are trade names or marks used in commerce (including WarmStart®, Millipore®, and RNAsecureTM among others), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 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.
Claims 1, 3-6, 9, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Broughton et al. (WO2020257356) in view of Seok et al. (Lab-on-paper for all-in-one molecular diagnostics (LAMDA) of zika, dengue, and chikungunya virus from human serum. 2020. Biosensors and Bioelectronics. 165: p. 1-8. Available online 20 June 2020).
This is a new rejection as necessitated by the claim amendments.
Regarding claim 1, Broughton teaches devices for detection of target nucleic acids (abstract), including devices comprising a sample chamber (instant thermal inactivation chamber) fluidically connected to an amplification chamber and a detection reagent chamber is fluidically connected to the amplification chamber (para 7). Broughton teaches the sample (thermal inactivation), amplification and detection chambers are arranged in a row (Figs. 3, 157-159.) The sample chamber of Broughton comprises a lysis buffer (para 6) where lysis may be performed by thermal means; i.e. thermal inactivation (para 461). Broughton also teaches a fluidic device may comprise a sample inlet that may be capable of sealing around a swab (para 464) and the swab may be inserted into a swab chamber (instant sample chamber) (para 131). Broughton further teaches the sample can be treated with protease, such as Protease K, before amplification; i.e. reagents to decompose the sample (para 431). Broughton teaches the amplification chamber comprises amplification reagents (para 22) and the detection chamber comprises a programmable nuclease (para 3) such as a Cas enzyme (para 354). Broughton further teaches the device is a lateral flow test strip connected to a reaction chamber (i.e. the detection chamber) (para 496) and that the detection of a target DNA by a DNA-activated programmable RNA nuclease (Cas enzyme) can be connected to a variety of readouts including lateral flow (para 364).
Broughton does not teach liquid flows through the sample chamber, the thermal inactivation chamber, the amplification chamber, and the detection chamber sequentially by a syphon effect or a capillary action; or the thermal inactivation chamber, the amplification chamber, and the detection chamber are composed of a continuous paper-based material.
Seok teaches a lab-on-paper system for all-in-one molecular diagnostics that conducts the entire process of nucleic acid testing that involves sampling, extraction, amplification, and detection is simply operated on a single paper chip (p. 1, Abstract and Fig. 2).
Seok teaches automatic flow on the paper chip (p. 2, col. 2), that reads on the claimed liquid flow by capillary action.
Seok states that such a system has the advantages of providing a simple diagnostic tool that is portable, low-cost, user-friendly, and sensitive (p. 1, Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Broughton and Seok to arrive at the instantly claimed invention. The modification would have entailed using the paper chip of Seok in the device of Broughton. Broughton teaches use of paper in multiple components of their device, including the sample pad (para 418), conjugate pad (para 419), and detection pad (para 426). One would have been motivated to use the paper chip of Seok as the basis of the device taught by Broughton for the advantage of portability and ease of use. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 3, Broughton teaches the sample chamber can have a filter between the chamber and the fluidic channel to the amplification or detection chambers (para 500).
Regarding claim 4, Broughton teaches a pump drives the fluidics in the assay moving sample from chamber to chamber (i.e. pushing fluids from one chamber to the next (para 713). Broughton further specifically teaches transfer of the sample may be by active transport aided by a pump (i.e. pushed out) (para 415).
Regarding claim 5, Broughton teaches pneumatic valves that move fluid from one position to the next (para 157), including moving the sample from the sample well (i.e. thermal inactivation chamber) to the amplification chamber (para 158).
Regarding claim 6, Broughton teaches pneumatic valves that move fluid from one position to the next (para 157), including moving the sample from the amplification chamber to the DETECTR (i.e. detection) chamber (para 158).
Regarding claim 9, Broughton teaches a heater configured to heat the amplification chamber (para 19).
Regarding claim 11, Broughton teaches that the sample chamber (thermal inactivation chamber) compris[ing] the lysis buffer and all of the materials in the amplification and detection chambers are lyophilized (i.e. freeze-dried) (para 519.
Regarding claim 12, Broughton teaches reagents can be placed onto a membrane (adsorbed to a holder material) by freeze drying to stabilize the dispensed molecules (para 456).
Regarding claim 13, Broughton teaches the detection reagent chamber comprising a programmable nuclease, a guide nucleic acid, and a labeled detector nucleic acid (probe), wherein the labeled detector nucleic acid is capable of being cleaved upon binding of the guide nucleic acid to a segment of a target nucleic acid (para 3).
Regarding claim 14, Broughton teaches that all of the materials in the amplification and detection chambers (e.g. Cas enzyme reaction reagents) are lyophilized (i.e. freeze-dried) (para 519.
Regarding claim 15, Broughton teaches reagents can be placed onto a membrane (adsorbed to a holder material) by freeze drying to stabilize the dispensed molecules (para 456).
Regarding claim 16, Broughton teaches amplification reagents comprise reagents for loop mediated amplification (para 22).
Regarding claim 17, Broughton teaches amplification splitters to split the incoming amplification reaction mix and dispense directly to the detection chambers (para 514 and Fig. 127). Broughton also teaches a lateral flow test strip connected to a reaction chamber (i.e. the detection chamber) (para 496) and detection of a target DNA by a DNA-activated programmable RNA nuclease (Cas enzyme) can be connected to a variety of readouts including lateral flow (para 364). Broughton further teaches multiple detection spots (chambers) for detecting multiple target nucleic acids on multiple support mediums (test strips) (para 442).
Claims 7, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Broughton et al. (WO2020257356) in view of Seok et al. (Lab-on-paper for all-in-one molecular diagnostics (LAMDA) of zika, dengue, and chikungunya virus from human serum. 2020. Biosensors and Bioelectronics. 165: p. 1-8. Available online 20 June 2020) as applied to claims 1, 3-6, 9, and 11-17 above, and further in view of Lafleur et al. (A rapid, instrument-free, sample-to-result nucleic acid amplification test. 2016. Lab on a Chip. 16(19): 3777-3787).
Neither Broughton nor Seok teach a wax valve (claim 7) composed of an independent wax layer or adsorbed to a holder material (claim 8) or that the wax valve is opened by heating with a temperature control unit (claim 10).
Lafleur teaches a nucleic acid amplification test based on two-dimensional paper networks. The test comprises collecting a sample with a swab, performing cell lysis and delivering the sample to a paper network comprising amplification and detection chambers (p. 3782, col. 1 and Fig. 1). Lafleur further teaches the use of wax valves that control flow, including a lysis valve that controls flow from the sample chamber into the 2DPN and amplification valves that control flow from the amplification zones into the detection zones and used heater to melt the wax and allow fluid to advance (p. 3783, col. 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Broughton and Seok with Lafleur to arrive at the instantly claimed invention. The modification would have entailed using the wax valves of Lafleur as the valves of Broughton and Seok. Lafleur adds wax valves to a paper chip similar to that of Seok and would easily have been implemented. One would have been motivated by the ability to control flow between chambers as taught in Lafleur with a simple valve that is easy to integrate. The device of Broughton included a heater configured to heat chambers. One of skill in the art would have known that a heater could also be used to control valves as in Lafleur. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Response to Arguments against Claim Rejection – previous 35 U.S. C § 102
The response asserts the '356 application fails to disclose the limitations of amended claim 1 (p. 8).
Applicant's arguments with respect to the rejection(s) of claim(s) 1, 3, 9, and 11-17 under 35 U.S. C § 102 over Broughton have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Broughton in view of Seok as described above in the new rejections of the claims.
Response to Arguments against Claim Rejection – previous 35 U.S. C § 103
The response asserts that the '125 application (Kellogg) fails to remedy the deficiencies of the '356 application (p. 9).
Applicant's arguments with respect to the rejection(s) of claim(s) 7, 8, and 10 under 35 U.S. C § 103 over Broughton in view of Kellogg have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Broughton in view of Seok, further in view of Lafleur as described above in the new rejections of the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682