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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Status of Claims
This action is response to papers filed 04/13/2026.
New claim 23 is acknowledged.
Claims 1 and 3-23 are pending and claims 1, 3-17, and 23 under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
Response to Remarks filed 04/13/2026
The amendments and arguments presented in the papers filed 04/13/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 12/16/2025 listed below have been reconsidered as indicated.
a) Applicant’s arguments, with respect to the rejections of claim(s) 1, 3-6, 9, and 11-17 under 35 U.S.C. 103 as being unpatentable over Broughton et al. in view of Seok et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection as presented below.
b) Applicant’s arguments, with respect to the rejections of claim(s) 7, 8, and 10 under 35 U.S.C. 103 as being unpatentable over Broughton et al. in view of Seok et al. and further in view of Lafleur have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection as presented below.
New and modified grounds of rejection are detailed below.
Specification
The specification includes the term “protease K”. This appears to be a typographical error intended to be “proteinase K”. Appropriate correction is required.
The use of terms which are trade names or marks used in commerce (including 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 Interpretation
Claims 1, 3-17, and 23 are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Claim Rejections - 35 USC § 112(b)
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, 3-17 and 23 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.
Claim 1 recites the limitation “the thermal inactivation chamber includes a reagent to thermally inactivate and decompose the sample”. It is unclear if a single reagent is intended to both thermally inactivate and decompose the sample. For purposes of examination a single reagent that provides one function is interpreted to provide the other.
Claims 3-17 and 23 are similarly indefinite because they directly or indirectly depend from claim 1.
Claim 23 recites the limitation “further comprising, between the thermal inactivation chamber and the amplification chamber or between the amplification chamber and the detection chamber, a wax valve to partition the thermal inactivation chamber and the amplification chamber”. The claim is unclear. It is unclear if the claim is intended only to require a wax valve to partition the thermal inactivation chamber and the amplification chamber, or if the claim is intended to require wax valve between both (1) the thermal inactivation chamber and the amplification chamber and (2) the amplification chamber and the detection chamber, or if the claim is intended to require either (1) or (2). For purposes of examination the claim is interpreted to require only a wax valve between the thermal inactivation chamber and the amplification chamber.
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, 3-17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Linnes et al. (US 20190126270) 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) and Gootenberg, et al. (Multiplexed and portable nucleic acid detection platform with Cas13, Cas12a, and Csm6. 2018. Science 360: 13 pages, on IDS dated 10/21/2021).
Regarding claim 1, Linnes teaches integrated paper-fluidic diagnostic assay devices, a device comprising a sample inlet, amplification chamber and lateral flow detection strip (detection chamber) arranged in a row (Figs. 1 and 2). Linnes further teaches the device may include a “sample/extraction” area (thermal inactivation chamber) (para 35). Linnes teaches the assay device comprises a plurality of assay areas defined by a plurality of thermally reversible barriers and states that a device comprising a sample inlet/amplification area, a waste pad and a detection area is a non-limiting device (para 35). Thus, Linnes teaches embodiments encompassed by a sample chamber, a thermal inactivation chamber, an amplification chamber, and a detection chamber arranged in a row which also reads on limitation that the thermal inactivation chamber, the amplification chamber, and the detection chamber are composed of a continuous paper-based material.
Linnes teaches the elements constitute a liquid flow path (Figs 1B and 2), with the sample flowing from the sample/extraction area to the amplification area and from the amplification area to the detection area (para 9). Linnes teaches paper-fluidic devices leverage the inherent wicking ability of porous materials to transport fluid through multiple reagent zones (para 5), which reads on flow by capillary action.
Linnes teaches transporting fluid through multiple reagent zones (para 5). Linnes further teaches the reagents necessary for the amplification of the biological molecule are present in the amplification area before the addition of the sample (para 104). Regarding extraction (thermal inactivation chamber),
Linnes does not teach (1) a sample chamber includes a swab inlet port into which a swab to which the sample is attached is inserted; (2) the thermal inactivation chamber includes a reagent to thermally inactivate and decompose the sample; or (3) the detection chamber includes a test strip to conduct a Cas enzyme reaction.
Regarding (1), Lafleur teaches sample-to-result nucleic acid amplification test based on two-dimensional paper networks. Lafleur teaches a device comprising a sample chamber which include lysis and processing, an amplification section and detection sections arranged in a row and constituting a liquid flow path (Fig. 3, shown below). Lafleur teaches a swab can be inserted into the sample chamber (p. 3782, col. 1, and Fig. 3).
Regarding (2), Lafleur also teaches the sample chamber comprises sample processing elements (Fig. 3) including buffers and reagents for lysis (p. 3782, col. 1), i.e. a thermal inactivation chamber. Lafleur states that the goal of the device was to provide an autonomous integrated sample-to-result NAAT (nucleic acid amplification test) system starting from nasal swab samples (p. 3784, col. 2). Lafleur also states that such a system (swab sample to answer) would be of great clinical value, providing ease-of-use and sensitivity (p.3784, col. 2).
Regarding (3), Gootenberg teaches a lateral flow detection strip using a Cas enzyme (Abstract). Gootenberg states that the method using the detection strips is a multiplexable, portable, rapid, and quantitative detection platform of nucleic acids.
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 Linnes and Lafleur with Gootenberg to arrive at the instantly claimed invention. The modifications would have entailed (1) separating the sample and thermal inactivation chambers. Such a design change would have been a matter of routine optimization well within the purview of one of skill in the art. Linnes teaches multiple configurations and explicitly states that the design examples are non-limiting. One of skill in the art would have been motivated to optimize function and control of elements. Linnes teaches a strength of paper fluidic devices is the ability to transport fluid through multiple reagent zones (para 5) and demonstrates the ability to control flow through as many as 7 regions (Fig. 10). The modifications would also have entailed (2) substituting the sample chamber for the sample chamber of Linnes. The substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. In addition, the supreme court that a simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc (2007) (see MPEP § 2143, B.). One would have been motivated to make the substitution by the benefit of increasing the ease-of-use as Linnes states a goal of heir device is to provide paper-fluidic diagnostic devices that require minimal user involvement (para 7). The modification would also entail (3) having reagents to decompose the sample included in the thermal inactivation chamber as Lafleur teaches. One would be motivated by the added benefit of ease-of-use. Lastly, the modification would entail using the Cas enzyme lateral flow detection strip of Gootenberg in the device of Linnes and Lafleur. One would have been motivated to substitute the Cas enzyme detection lateral flow strip by the rapid and quantitative results provided by the detection system. One would further have been motivated by the fact that the integration of the lateral flow detection of Gootenberg would retain the portable user-friendly paper diagnostic device of Linnes and 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.
Regarding claim 3, Linnes teaches a filter at the sample inlet (Fig. 2) that is designed to filter large particles (para 101) but does not teach verbatim between the sample chamber and the thermal inactivation chamber, a filter to purify the sample.
However, 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 modify the teachings of Linnes to arrive at the instantly claimed invention. The modification would have entailed placing the filter between the sample chamber and thermal inactivation chamber. Such a change in order of elements and design would have been a matter of judicious selection and routine optimization well within the purview of one of skill in the art. One would have been motivated by a desire to optimize performance of the device. 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 4, Lafleur teaches a syringe which drives buffer through tubing containing dry lysis reagents into the sample chamber (p. 378, col. 2). Lafleur further teaches a lysis valve tubing which reads on a pushing-out path.
Regarding claim 5, Linnes teaches a valve between the sample/extraction area and amplification area (para 35), which reads on a valve between the thermal inactivation chamber and the amplification chamber.
Regarding claim 6, Linnes teaches a valve between the amplification chamber and the detection area (para 35).
Regarding claim 7, Linnes teaches wax printed fluidic control valves (para 102).
Regarding claim 8, Linnes teaches printing a band of wax onto a porous nitrocellulose membrane (para 102).
Regarding claim 9, Linnes teaches heating the amplification area (paras 41, 104) and further teaches thermal control is achieved using an SAMD21 microcontroller and TMP37 low voltage temperature sensors (para 132 and Fig. 13).
Regarding claim 10, Linnes teaches opening a wax valve by increasing temperature using a thin-film heater (para 113). Linnes further teaches using a temperature controller (an SAMD21 microcontroller and TMP37 low voltage temperature sensors (para 132 and Fig. 13).
Regarding claims 11 and 12, Lafleur teaches lysis reagents are dried (p. 3779, col. 2) and that amplification reagents are lyophilized (freeze-dried) (p. 3779, col. 2). Lafleur further teaches the amplification reagents are lyophilized (freeze-dried) onto reagent pads (a holder material) ((p. 3779, 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 modify the teachings of Linnes Lafleur and Gootenberg to arrive at the instantly claimed invention. The modification would have entailed using the on-paper extraction/lysis area of Linnes and applying the freeze-drying process for the amplification reagents of Lafleur to the lysis agents. One would have been motivated by the stated desire of both Linnes and Lafleur to provide an all-in-one diagnostic device that is paper-based. Substitution of a known method by a second method with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. 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 13, Gootenberg teaches a Cas enzyme reaction comprising a Cas enzyme (Cas 13 in figure), a guide nucleic acid, and a probe (ZIKV in figure) that generates a molecule (FAM-biotin in figure) necessary for a separate reaction (cleavage) (Fig. 3A).
Regarding claim 14, Gootenberg teaches the reagents for SHERLOCK (Cas enzyme reaction) detection can be lyophilized (freeze-dried) (p. 1, col. 1).
Regarding claim 15, Gootenberg does not explicitly teach that the lyophilized reagents are adsorbed to a holder material.
Lafleur teaches detection reagents are lyophilized (freeze-dried) onto reagent pads (a holder material) ((p. 3779, 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 modify the teachings of Linnes Lafleur and Gootenberg to arrive at the instantly claimed invention. The modification would have entailed applying the freeze-drying process for the detection reagents of Lafleur to the Cas enzyme reactions of Gootenberg agents. One would have been motivated by the stated desire of both Linnes and Lafleur to provide an all-in-one diagnostic device that is paper-based. Substitution of a known method by a second method with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. Further, the detection reagents of both Lafleur and Gootenberg were used on lateral flow strips/ 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 16, Linnes teaches loop mediated isothermal amplification (para 103).
Regarding claim 17, Lafleur teaches multiplexing by routing to multiple isothermal amplification zones and lateral flow detection strips (p. 3782, col. 2 and Fig. 3) and uses these strips to target two genes (p. 3778, col. 1 and Fig. 5).
Regarding claim 23, Linnes teaches a valve between the sample/extraction area and amplification area (para 35), which reads on a valve between the thermal inactivation chamber and the amplification chamber. Linnes further teaches valves are wax (para 102).
Conclusion
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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