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 .
Status of the Application
Claims 1-20 are pending and examined herein.
Priority
This application, is a divisional of 15/506,964, filed on 2/27/2017 now abandoned, which is a 371 of PCT/SG2015/050291 filed on August 31, 2015, which in turn claims priority to Singapore application number 10201405360P filed on August 30, 2014.
Maintained Rejections
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-12, 14, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton (US 2004/0248322).
Regarding claim 1, Charlton teaches a device and method for a paper-based assay comprising: applying a sample directly to a test area (marked sample additional zone) comprising immobilized binding partner for analytes that may be in the sample. See paras [0016], [0038], [0049], [0061], [0073] and [0082]. The device of Charlton is a test strip comprising a substrate addition zone for receiving a substrate and is located upstream of the marked sample addition zone (buffer pad is upstream from the test area, which is the marked sample addition zone, par. 92; 100 is upstream from 140, Fig. 7). Wherein 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 and separated by the test membrane and conjugate pad, par. 59, 91 and 102; see buffer pad, 100, seen as the claimed substrate addition zone separated from test area, 140, seen as marked sample addition zone, by test membrane, 130, in Fig. 7). Charlton teaches in one embodiment where a conjugate pad is not present and the conjugate is pre-dried directly on the membrane that comprises the test area and control area (sample is missed with a detector agent that is pre-dried at the marked sample addition zone.) Wash buffer may be applied directly on the test membrane or to the buffer pad. See para [0104].
While Charlton does not disclose one specific embodiment of a test strip and method for using as claimed, Charlton does disclose all limitations of the claimed method as written.
With respect to claim 2, 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 and separated by the test membrane and conjugate pad, par. 59, 91 and 102; see buffer pad, 100, seen as the claimed substrate addition zone separated from test area, 140, seen as marked sample addition zone, by test membrane, 130, in Fig. 7).
With respect to claim 3, Charlton discloses an embodiment having only the substrate zone and the test membrane (i.e. marked sample additional zone) as discussed above.
With respect claims 7-9, Charlton discloses nitrocellulose porous membrane for use in the method. See paras [0038] and [0112]
With respect to claim 10, Charlton teaches the marked sample addition zone (Charlton’s test area) is subdivided into two or more areas, each comprising a different capture agent (more than one type of analyte can be detected in a single test strip with two or more test areas, which reads on the marked sample addition zone subdivided into two or more areas wherein each test area of Charlton is considered a subdivided area, par. 85).
With respect to claim 11, while Charlton does not specifically use the word “array” to describe the reagent areas in the marked sample addition zone, by definition, an array is an arrangement. Charlton discloses an arrangement of binding agent at the test area forming shapes or symbols such as a “+”. See para [0084].
With respect to claim 12, Charlton discloses capture agent such as antibodies. See para [0082].
With respect to claim 14, Charlton teaches test strip comprising control areas. See [0013].
With respect to claim 18, Charlton teaches aqueous buffer (i.e. substrate) contacted with the test strip. See para [0010].
With respect to claim 20, Charlton disclose visual colorimetric signal. See paras [0031].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Charlton as applied to claim 1 above, and further in view of Egan et al (US 9086,408).
Charlton teaches the device and method as discussed above. Charlton differs from the instant claim in failing to teach where the sample is mixed with detector agent that is pre-dried on a applicator and where said applicator is applied to the marked sample addition zone.
Egan teaches, kits and method for using the same comprising a sample collection device (applicator) having incorporated solid reagent component such as capture and detection probes that are lyophilized or dried on solid support. See column 12, lines 5-23, column 13, lines 1-21. In use, sample is mixed with labeled reagent in the applicator and applied to a test strip using the same. Egan teaches their device and process provides the advantage of providing enhanced sensitivity that minimizes the steps required to process sample and simplifies the process for reading results that also reduces the level of training required for an operator. See column 1, lines 36-55.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Charlton by using a sample collection device taught by Egan in order to preprocess the sample and incubate any analyte with labeled reagent before applying the mixed solution to a marked sample area for the advantage of a simple sample processing step in an immunoassay method that also minimizes the steps required thus leading to enhanced sensitivity and ease of reading results as well as reducing the level of training required for a user.
Claims 5, 6, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton as applied to claim 1 above, and further in view of Wei et al (US 2006/0019406).
Charlton teaches device and method as discussed above. Charlton differs from the instant claim in failing to teach the use of enzyme as the label.
Wei discloses immunoassay method and device using antibodies, antigens, nucleotide sequences (pg.4, [0037]) conjugated enzyme probes (pgs. 5-6, [0033]), such as alkaline phosphatase.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method taught by Charlton by using detection reagents conjugated to enzyme labels as taught by Wei because such labels are well known in the art and would have been expected to perform the same function and accomplish the intended purpose of providing visible results upon binding to analyte captured in a test area.
A skilled artisan would have had a reasonable expectation of success in using the enzyme labels taught by Wei in the method of Charlton because Wei teaches that enzyme labels are functionally equivalent to the colloidal particles in Charlton.
Regarding claims 16-17, Wei discloses enzyme substrate systems to include “… nitro blue tetrazolium-5-bromo-4-chloro-3-indolyl phosphate, or derivative or analog thereof...” amongst other referenced substrates (pgs.6, [0033]); this encompasses BCIP, NBT, combined BCIP/NBT.
It would have been obvious for one of ordinary skill in the art to use the enzyme labels of Wei in the method of Charlton as discussed above. It further would have been obvious to select the appropriate substrate based on the enzyme reagents because Wei teaches well known and commercially available substrates.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Charlton as applied to claim 1 above, and further in view of Jerome (US 2003/0049167).
Regarding claims 13 and 15, Charlton discloses a method and device as discussed above but fails to teach color marker to assist in the localization of the capture agent on the test strip and a marked sample addition zone.
However, Jerome teaches a marked sample addition zone (capture area marked on the test strip with a dye, pg. 23, ¶ 101, lines 18-22). The claim language and disclosure do not specify how (or if) the capture agent being marked differs from the marked sample addition zone to which the capture agent(s) are immobilized to. Therefore, in one interpretation, upon the immobilization of the capture agents onto a marked sample addition zone, as taught by Jerome, the capture agents are, at a minimum, instantly mixed with a colored marker (e.g., dye) at the point(s) of contact on a marked test strip membrane (Specification, pg. 11, [0063], line 1-3, “…capture agent may be mixed with a coloured marker to assist in the localization of the or each capture agent [on membrane]… colour markers include but are not limited to dyes and colour beads”).
Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the device and method taught by Wei by adding markings, such as a dye, as taught by Jerome to mark the position of the capture zone upon the solid phase because doing so allows the zone to be visually or instrumentally determined even then there is no label immobilized at the site. (see Jerome, para 101]. A skilled artisan would have had a reasonable expectation of success in using markers such as dyes to mark different areas of a test strip because this is well known in the art and provides the advantage of enabling a user to quickly locate test and/or control zones in the event that no visible labels is observed.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Charlton as applied to claim 1 above, and further in view of Kirkegaard (US 8,153,444).
Regarding claim 19, Charlton discloses a method and device as discussed above.
Charlton differs from the instant invention in failing to teach a method where substrate is applied on an underside of the test strip.
However, Kirkegaard discloses methods and device for detecting low levels of ligands using a chromatographic specific binding assay system (See Col. 3, lns 23-42). In one embodiment (e.g., Fig.1A-1B), Kirkegaard teaches a conjugate pad (15) applied to the underside of a membrane “tail” (60) in contact with a sample receiving pad (13), further in contact with permeable membrane (12); after application of substrate to the underside of the strip, initiated by the addition of a sample (10) the “tail” (60) is folded over onto the sample receiving pad (13), as seen in Fig. 1A-1B. See also Col. 8, Lns 20-23.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method and device taught by Charlton to apply the substrate to an underside of the test strip as taught by Kirkegaard to arrive at the instant claim because Kirkeggard teaches that the placement and application of the substrate/conjugate pad either on the top side or underside of a test strip is functionally equivalent and the particular placement of these membrane is an obvious matter of design choice. (See MPEP 2144.04 VI C.)
Response to Arguments
Applicant’s arguments and amendment to claim 1 filed 02 February 2026, with respect to the rejection of claims 1-20 under 35 USC 112 (b) have been fully considered and are persuasive. This rejection has been withdrawn.
Applicant's arguments filed 02 February 2026 with respect to the rejections of claims 1-20 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues instant claim 1 requires a method in which sample is mixed with detector agent as a solution prior to application to the test area and that Charlton does not disclose this method because the test strip of Charlton comprise a conjugate area for binding the analyte of interest and the method comprises adding a wash buffer to deliver the conjugate to the test area.
This argument is not persuasive. Instant claim 1 clearly recites a method comprising two alternative embodiments as follows: “wherein the sample is mixed with a detector agent prior to step (a), OR wherein the sample is mixed with a detector agent that is pre-dried at the marked sample addition zone”.
While Charlton discloses different embodiments where the conjugate is present on the test strip in a conjugate pad, Charlton also clearly teaches in one embodiment where a conjugate pad is NOT present and the conjugate is pre-dried directly on the membrane that comprises the test area and control area (i.e. sample is mixed with a detector agent that is pre-fried at the marked sample addition zone.). Wash buffer is applied directly on the test membrane. See Charlton para [0104]. Therefore, Charlton discloses the claims as written.
All other arguments are centered on the Charlton reference and thus are not persuasive for the same reasons.
Conclusion
All claims are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
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/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 March 6, 2026