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 .
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timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR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 06/08/2026 has been entered.
Priority
The present application filed on 01/12/2022, is a divisional of U.S. Application No. 15/506,964, filed on 02/27/2017, is a 371 of PCT/SG2015/050291, filed on 08/31/2015, and claims priority to Singapore Patent Application No. 10201405360, filed on 08/30/2014.
The contents of this application are supported in the original disclosure provided in Singapore Patent Application No. 10201405360, filed on 08/30/2014, thus instant claims 1-20 have an effective filing date of 08/30/2014.
Information Disclosure Statement
One Information Disclosure Statement(s) (IDS), filed on 01/12/2022, is acknowledged and considered.
Claim Status
Claims 1-20 are pending and examined herein below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Claims 1-4, 7-12, 14, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton (US20040248322 A1, Pub. Date: 12/09/2004, provided in IDS filed on 01/12/2022, Cite No. H), in view of Jones et al., (US 7867780 B2, Date: 01/11/2011).
Throughout the disclosure, Charlton teaches a device and different embodiments of a method for a paper-based assay. In some embodiments, the method for the paper-based assay comprises applying a sample directly to a test area comprising an immobilized binding partner for analytes that may be in the sample. Charlton teaches a device comprising a test strip comprising a substrate addition zone for receiving a substrate that is located upstream from the marked sample addition zone (buffer pad is upstream from the test area, which is the marked sample addition zone, para 92; 100 is upstream from 140, Fig. 7). Charlton further teaches the substrate addition zone is configured such that the fluid, when applied to the substrate zone, flows through the substrate zone and into the marked sample addition zone (fluid is applied to the buffer pad and flows through the buffer pad to the test area, par. 92 and 102). Charlton teaches the substrate addition zone and the marked sample addition zone are in a spaced apart configuration (buffer pad is upstream from the teat area). In one embodiment, Charlton teaches the detection agent is pre-dried directly on a zone on the test strip. Charlton further teaches a wash buffer may be applied directly on the test membrane or to the buffer pad/zone, a zone capable of functioning as the substrate addition zone.
Regarding claim 1, Charlton teaches a method of detecting the presence of an analyte of interest contained in a sample, said method comprising the steps of: (a) applying said sample directly onto at least one capture agent that specifically binds to the analyte and retains the analyte, the at least one capture agent being located only in a marked sample addition zone of a test strip (Charlton, US20040248322 A1: paras 0016, 0049, 0073, 0082), wherein the test strip comprises a substrate addition zone for receiving a substrate and the marked sample addition zone for receiving the sample (Charlton, US20040248322 A1: para 0092, buffer pad= substrate addition zone), wherein the analyte present in the sample is first immobilized in the marked sample addition zone by binding with the at least one capture agent, and (b) applying a substrate to the substrate addition zone located upstream of the marked sample addition zone, wherein the substrate addition zone is configured such that the substrate, when applied to the substrate addition zone, flows through the substrate addition zone and into the marked sample addition zone to interact with the immobilized analyte to emit a detectable signal from said marked sample addition zone to confirm the presence or absence of said analyte in said sample. (Charlton, US20040248322 A1: paras 0007and 0092). In one embodiment, Charlton teaches a detector agent may be pre-dried at a zone on the test strip (Charlton, US20040248322 A1: 0009). Charlton does not teach wherein the sample is mixed with a detector agent prior to step (a) or with a detector agent that is pre-dried and the sample is mixed with the detector agent without a buffer at the sample addition zone.
Throughout the disclosure, Jones teaches single-layer lateral flow formats, materials, and methods used for detecting the presence of an analyte in a sample. Jones teaches a single-layer lateral flow format comprising a test strip comprising a dry porous medium. Jones further teaches the dry porous medium comprises a single hydrophobic matrix. In one embodiment, Jones teaches a sample application zone, a conjugate release zone, and capture zone wherein the conjugate release zone comprises a labeled binding reagent. In this embodiment, Jones further teaches the labeled binding reagent specifically binds to the analyte to form a first complex comprising labeled binding reagent and analyte. Jones further teaches the labeling reagent is pre-dried on the test strip prior to liquid sample application wherein the dry labeling reagent on the test strip is released upon contact with the liquid sample, in the absence of buffer.
Jones teaches wherein the sample is mixed with a detector agent that is pre-dried on the test strip, wherein the sample is mixed with the detector agent without a buffer (Jones et al., US 7867780 B2: col. 2, lines 39-50).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Charlton with the teachings of Jones in order to modify the sample and detector agent mixing step to comprise drying the detector agent on the test strip and mixing it with the sample without buffer, as taught by Jones. Jones does not explicitly teach pre-drying the detection agent at the sample addition zone but a skilled artisan would have recognized that pre-drying the detection agent at the sample addition zone, with the capture agent already immobilized, would necessarily and inevitably simplify the method by not requiring multiple parts/zones and would speed up reaction time by eliminating the need to wait for the detection agent to flow towards the immobilized analyte in a separate zone. Thus, at the time of filing, for a skilled artisan, it would have been prima facie obvious to try pre-drying the detection agent on the finite number of zones available on the test strip in order to determine the optimal position for pre-drying the detection agent to arrive at the claimed invention. A skilled artisan would have a reasonable expectation of success because trying a finite number of known solutions would yield expected and predictable results. Further, a skilled artisan would have been motivated to combine these teachings in order to make the modification of not requiring buffer to move the detection agent from a separate zone and for mixing with the sample because without buffer, contact between analyte and detection agent would be maximized and in turn would improve accuracy and efficiency of results, since contact would be compromised or reduced due to flow problems in the presence of buffer moving assay components contained in separate zones on different, and potentially incompatible, materials. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teaching amounts to combining known elements/components, known to perform the same function separately as they do when combined, to yield expected and predictable results.
Regarding claim 2, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches wherein the substrate addition zone and the marked sample addition zone are in a spaced apart configuration, optionally wherein the substrate addition zone and the marked sample addition zone are in an adjacent configuration, optionally wherein the substrate addition zone and the marked sample addition zone are in an immediately adjacent configuration (Charlton, US20040248322 A1: paras 0092, para 0059; Fig. 4, buffer pad [110] is upstream and spaced apart from sample addition/test zone [140]).
Regarding claim 3, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches wherein the substrate addition zone and the marked sample addition zone are not interposed by any other zone (para 0092).
Regarding claim 4, Charlton and Jones teach all the limitations in claim 1. The instant Specification clarifies that an applicator “may be a membrane, including but not limited to porous membranes, such as a filter membrane. Examples of filter membranes include but are not limited to glass fibers,” among other options (instant Spec, para 0020). The instant Specification further clarifies that the terms “applied” or “contacted” are used interchangeable, which in the art, in the context of lateral flow methods and devices, is understood to mean separate elements or components that are in communication (instant Spec, para 0022). Thus, using the broadest reasonable interpretation and in light of the instant Specification, Jones further teaches wherein the sample is mixed with the detector agent that is pre-dried on an applicator, and wherein said applicator is applied to the marked sample addition zone (Jones et al., US 7867780 B2: col. 1, lines 58-64; col. 2, lines1-16 [conjugate pad may be glass fiber = applicator] and lines 35-50; and col. 2, lines 39-50).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Charlton with the teachings of Jones in order to modify the reaction/mixing zone for the sample and detector agent. A skilled artisan would have been motivated to combine these teachings in order to make this modification because the material used for the applicator would enable fast wicking of sample and better facilitate release of the detection agent (see Jones, col 1, lines 43-57). A person having ordinary skill in the art would have a reasonable expectation of success because combining these teaching amounts to combining known elements/ components, known to perform the same function separately as they do when combined, to yield expected and predictable results.
Regarding claim 7, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches wherein the test strip is a porous membrane (Charlton, US20040248322 A1: paras 0038 and 0112).
Regarding claim 8, Charlton and Jones teach all the limitations in claim 1 and Charlton teaches the limitations of claim 7. Charlton further teaches wherein the porous membrane is selected from the group consisting of nitrocellulose membrane, polyvinylidene fluoride (PVDF) membrane, and filter paper (Charlton, US20040248322 A1: para 0038 and 0112).
Regarding claim 9, Charlton and Jones teach all the limitations in claim 1 and Charlton teaches the limitations of claim 8. Charlton further teaches wherein the membrane is nitrocellulose membrane (Charlton, US20040248322 A1: para 0038 and 0112).
Regarding claim 10, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches the method according to claim 1, wherein the marked sample addition zone is subdivided into two or more areas, each area comprising the same or different capture agent (Charlton, US20040248322 A1: para 0085).
Regarding claim 11, Charlton and Jones teach all the limitations in claim 1 and Charlton teaches the limitations of claim 10. Charlton further teaches the method of claim 10, wherein the two or more areas comprises an array (Charlton, US20040248322 A1: para 0084-0085, more than one positive test area or vertical lines or shapes/symbols can be arranged in test area).
Regarding claim 12, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches wherein the capture agent is selected from the group consisting of antibodies, antigens, oligonucleotides and peptides (Charlton, US20040248322 A1: para 0006).
Regarding claim 14, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches the method according to claim 1, wherein the test strip further comprises one or more control areas located within or without of the marked sample addition zone (Charlton, US20040248322 A1: para 0082).
Regarding claim 18, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches the method according to claim 1, wherein the substrate is contacted with the test strip in an aqueous solution, polymer solution, or a polymer gel (Charlton, US20040248322 A1: para 0011 [conjugate = substrate, buffer= aqueous solution]).
Regarding claim 20, Charlton and Jones teach all the limitations in claim 1. Charlton further teaches the method of claim 1, wherein the detectable signal is selected from the group consisting of a colorimetric signal, a fluorescent signal, a chemiluminescent signal, an electrochemiluminescent signal and an electrochemical signal (Charlton, US20040248322 A1: para 0084, detectable signal visualized =colorimetric).
Claims 5-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton (US20040248322 A1, Pub. Date: 12/09/2004, provided in IDS filed on 01/12/2022, Cite No. H), in view of Jones et al., (US 7867780 B2, Date: 01/11/2011), as applied to claim 1, and further in view of Wei et al, (US 20060019406 A1, Pub. Date: 01/26/2006, provided in IDS filed on 01/12/2022, Cite No. I).
Regarding claims 5-6, the teachings of Charlton and Jones are discussed herein above. Charlton and Jones teach all the limitation of claim 1. Charlton and Jones do not teach detector agent is selected from the group consisting of antibodies, antigens, oligonucleotides and peptides, and wherein the detector agent is conjugated to an enzyme and do not teach the enzyme is selected from the group consisting of alkaline phosphatase, beta-galactosidase, glucose dehydrogenase, and horseradish peroxidase.
Throughout the disclosure, Wei teaches a lateral flow assay device for detecting the presence or quantity of an analyte present in a sample. Wei teaches the lateral flow assay device comprises a porous membrane in communication with a conjugate pad and a wicking pad. Wei teaches the porous membrane has a detection/test zone where a first capture reagent is immobilized and configured to bind at least a portion of the analyte upon direct sample application. Wei further teaches detection probes initially on a conjugation pad move towards the detection/test zone with the addition of buffer. Wei teaches a signal is generated if analyte is present in the sample and is immobilized at the detection/test zone. The control zone is located downstream from the detection zone on the porous membrane and has a second capture reagent immobilized within the control zone. The conjugate pad is located upstream from the detection zone, and has detection probes with specific binding members for the analyte. A buffer release zone is located upstream of the conjugate zone and for buffer addition.
Wei teaches wherein the detector agent is selected from the group consisting of antibodies, antigens, oligonucleotides and peptides, and wherein the detector agent is conjugated to an enzyme [claim 5] and wherein the enzyme is selected from the group consisting of alkaline phosphatase, beta-galactosidase, glucose dehydrogenase, and horseradish peroxidase [claim 6] (Wei et al., US 20060019406 A1: paras 0037 and 0033).
Regarding claims 16-17, Charlton and Jones teach all the limitation of claim 1. Charlton and Jones do not teach wherein the substrate is an enzymatic substrate and do not teach the enzymatic substrate is selected from the group consisting of BCIP, NBT, or combined BCIP/NBT, TMB, DAB, glucose/potassium ferricyanide/Fe3+, or X-gal.
Wei, in the same field of endeavor, teaches wherein the substrate is an enzymatic substrate and wherein the enzymatic substrate is selected from the group consisting of BCIP, NBT, or combined BCIP/NBT, TMB, DAB, glucose/potassium ferricyanide/Fe3+, or X-gal (Wei et al., US 20060019406 A1: para 0033).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Charlton, in view of Jones, with the teachings of Wei in order to substitute the substrate for an enzymatic substrate, as taught by Wei. A skilled artisan would have been motivated to combine these teachings and make this substitution because using a binding pair detection system, comprising an enzyme and detection agent, in the method of Charlton, in view of Jones, would enable detection and quantification of analyte present in the sample (see Wei et al., US 20060019406 A1: para 0033 reference by incorporation of U.S. 4275149A, Pub. Date: 06/23/1981, col. 1, lines 41-59). At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teaching amounts to a simple substitution between known elements/components, with each of their functions already known in the art, to yield expected and predictable results.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton (US20040248322 A1, Pub. Date: 12/09/2004, provided in IDS filed on 01/12/2022, Cite No. H), in view of Jones et al., (US 7867780 B2, Date: 01/11/2011), as applied to claim 1, and further in view of Jerome et al., (US 20030049167 A1, Pub. Date: 03/13/2003, provided in IDS filed on 01/12/2022, Cite No. G).
Regarding claims 13 and 15, the teachings of Charlton and Jones are discussed herein above. Charlton and Jones teach all the limitation of claim 1. Charlton and Jones do not teach the capture agent is mixed with a colored marker and do not teach the marked sample addition zone is marked on the test strip.
Throughout the disclosure, Jerome teaches a test device and method for determining the presence or absence of an analyte in a fluid sample. Jerome teaches the test device includes a support bearing a mark thereon and a matrix defining an axial flow path. Jerome further teaches an observation area in the test device becomes transparent, allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Jones teaches an embodiment where said mark presents a negative result as a minus (-) signal in the absence of analyte in the sample. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a visible plus (+) signal.
Jerome teaches wherein the capture agent is mixed with a colored marker to assist in the localization of the or each capture agent on said test strip [claim 13] (Jerome et al., US 20030049167 A1: para 101). Jerome further teaches wherein the marked sample addition zone is marked on the test strip with a dye or outline, optionally wherein the dye is a washable dye [claim 15] (Jerome et al., US 20030049167 A1: para 101).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Charlton, in view of Jones, with the teachings of Jerome in order to modify the visibility of capture agent and the sample addition zone with a visible marking, as taught by Jerome. A skilled artisan would have been motivated to combine these teachings and make this modification because making the capture agent visible with a color marker and immobilizing it on the sample addition zone enables the sample addition zone to be defined and the capture agent to be localized allowing for the sample addition, also the capture/test zone, to be visually or instrumentally determined. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teaching amounts to combining known elements/components, known to perform the same function separately as they do when combined, to yield expected and predictable results.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Charlton (US20040248322 A1, Pub. Date: 12/09/2004, provided in IDS filed on 01/12/2022, Cite No. H), in view of Jones et al., (US 7867780 B2, Date: 01/11/2011), as applied to claim 1, and further in view of Kirkegaard et al., (US 8153444 B2, Date: 04/10/2012, provided in IDS filed on 01/12/2022, Cite No. G).
Regarding claim 19, the teachings of Charlton and Jones are discussed herein above. Charlton and Jones teach all the limitation of claim 1. Charlton and Jones do not teach the substrate is applied on an underside of the test strip.
Throughout the disclosure, Kirkegaard teaches a chromatographic specific binding assay strip device. Kirkegaard teaches the device comprises a non-permeable platform strip and a permeable membrane testing strip placed on the non-permeable platform strip. Kirkegaard teaches the testing strip comprises at least one capture reagent site with capture reagent immobilized for binding at least one specific analyte. Kirkegaard further teaches the testing strip also comprises a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip. Kirkegaard further teaches the testing strip also comprises a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip. Kirkegaard teaches the testing strip further comprises a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad, which is capable of functioning as a substrate addition zone, positioned on said supporting strip. Kirkegaard teaches said conjugate pad comprises a semi-permeable membrane containing a colorant conjugate. Kirkegaard teaches one embodiment where the conjugate pad, which functions as a substrate addition zone, is on the underside of the platform and testing strips.
Kirkegaard teaches wherein the substrate is applied on an underside of the test strip (Kirkegaard et al., US 8153444 B2: col. 8, lines 20-24, Figs. 1A-B [conjugate pad (15) is on underside of platform strip (60) and test strip (12)]).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Charlton, in view of Jones, with the teachings of Kirkegaard in order to modify the application site of the substrate to the underside of the test strip, as taught by Kirkegaard. A skilled artisan would have been motivated to combine these teachings to make this modification because the substrate addition zone would not be in direct communication with the test zone, and arranging the pads/zones in this manner affects buffer flow rate, enabling reaction time between substrate and detection agent to be optimized. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teaching amounts to combining known elements/components, known to perform the same function separately as they do when combined, to yield expected and predictable results.
Response to Arguments
Claim Rejections Under 35 U.S.C. § 103- Obviousness
Regarding rejection under 35 U.S.C. 103 of claims 1-3, 7-12, 14, 18, and 20, Applicant traverses this rejection and presents arguments, filed on 06/08/2026. Applicant argues that the base reference, Charlton, does not teach the limitation(s) “sample is mixed with a detector agent prior to step (a)” of claim 1. For purposes of clarifying the record, instant claim 1 contains the alternative limitation of “sample is mixed with a detector agent prior to step (a) or mixed with a detector agent that is pre-dried at the marked sample addition zone,” and Charlton does teach a “sample is mixed with a detector agent that is pre-dried at the marked sample addition zone” (see Charlton et al., paras 0009 and 0011). Further, Applicant’s arguments have been considered but are moot because amendments to claim 1 necessitated a new ground of rejection that does not rely solely on the references applied in the prior rejection of record for the teaching or matter specifically challenged in the argument.
Regarding rejection under 35 U.S.C. 103 of claim 4 over Charlton in view of Egan, of claims 5, 6, 16, and 17 over Charlton in view of Egan, of claims 13 and 15 over Charlton in view of Jerome, and of claim 19 over Charlton in view of Kirkegaard, Applicant traverses these rejections and presents arguments, filed on 06/08/2026. Applicant’s arguments are centered around the base reference, Charlton, and thus are moot because amendments to claim 1 necessitated a new ground of rejection that does not rely solely on the references applied in the prior rejection of record for the teaching or matter specifically challenged in the argument.
Conclusion
All examined claims are rejected. No claims are allowed.
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/MELISSA LIZETTE LIRIANO-NG/
Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 July 10, 2026
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