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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/08/2025 has been entered.
Priority
This application filed on 02/17/2021 is a national stage entry of PCT/US2019/047432 which claims benefit to provisional application 62720290, filed on 08/21/2018.
Status of the Claims
Claims 1-7 and 11-15 are pending. Claim 1 is amended. Claims 3-4 and 11-13 are withdrawn as being drawn to non-elected inventions. Claims 8-10 are cancelled. Claims 1-2, 5-7, and 14-15 are examined below.
Withdrawn Rejection
The rejection of claims 1-2, 5-7, and 14-15 under 35 U.S.C. 103 has been withdrawn due to the amendment of the claims with “each test line being a continuous elongate stripe”. Further, applicant’s argument that the 1-D scan clause is structural, is persuasive. See new grounds of rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-7, and 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites “each test line being a continuous elongate stripe”. Applicant, at remarks page 6, indicates support for the amendment of claim 1 at paragraph [0053] and Figures 2-6A of the originally filed application. However, paragraph [0053] recites “multiple slanted test lines” and that the “disclosed embodiments, “test lines” can include shapes other than lines, including circles, ovals, rectangles, etc.” There is no mention of a “continuous elongate stripe” or a continuous test line or shape. Figures 2-5 are renderings of different variations of the test strip with various constellations of test lines. However, the drawings do not support whether the test lines are applied in a “continuous” way or for example by blotting a multitude of detection agents in close proximity. Figure 6, according to the instant specification on page 16, paragraph [0095], lines 4-6, is the result of 30 scans and further is not at a resolution high enough to determine whether the lines are continuous or not. As such neither the specification nor the drawings support the amendment reciting “a continuous elongate stripe” and therefore the amendment is considered new matter.
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, 5-7, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al., US20120003756A9 (see PTO-892, 01/31/2023), in view of Schwind et al.¸US8053226B2, O’Farrell et al., US11016090B2, and Lambotte et al., US7378285B2 see (PTO-892, 06/20/2024).
Regarding claim 1, Choi teaches a lateral flow assay (Choi, column 4, lines 24-25), which is also directed to multiple analyte detection with multiple antibody-dye conjugates and antibody specific for each antigen immobilized in a separate zone on the membrane each test line providing distinctive information for each specific antigen (test strip for multiplexed lateral flow assays; plurality of test lines; Choi, column 7, lines 57-64). Choi further teaches a test strip comprising a reservoir area or sample well for the uptake of the sample which may also contain europium particle-specific binding partner conjugates which may bind an analyte in the sample (first section configured to receive a sample containing analytes, providing conjugated rare earth phosphor particles, capable of binding to at least one of the analytes) and the analyte/specific binding partner complex is wicked through a wicking membrane until a test band is formed (Choi, column 8, lines 20-35 and Fig. 4). Choi further teaches that the test band is formed where another specific binder of the analyte captures the analyte/specific binding partner complex thus forming a test band and the sample is further wicked and encounters a binding partner to the specific binding partner impregnated in the wicking membrane and a control band is established (Choi, column 8, lines 29-35). Put another way, Choi teaches a lateral flow assay test strip with multiple test lines for capturing various analytes labeled with multiple antibody-dye conjugates. Choi further teaches that the signal may be generated by a rare earth chelate, in particular a lanthanide(III) chelate and further the label may be europium(III), terbium(III), samarium(III), dysprosium(III), or a combination thereof (plurality of conjugated rare earth phosphor particles; Choi, column 4, lines 35-39 and Figure 2). As such Choi teaches a plurality of test lines where the first test line is configured to capture conjugated rare earth phosphor particles bound to the first analyte and the second test line is configured to capture conjugated rare earth phosphor particles bound to the second analyte. Choi further teaches an absorbent pad used for removing excess fluid that has already passed through the reaction membrane and further teaches a first pad, second pad and wicking membrane connected to a plastic plate (first, second and third section (Choi, column 7, lines 38-39). Choi further teaches a sample application area at the bottom of the strip and a test and control line above the sample well and as such teaches a first section aligned with a bottom edge of the test strip and the sample flow in a direction towards a top edge of the test strip (Choi, Figure 3). Choi further teaches that capture reagent may be immobilized on the membrane as thin lines or bands (continuous elongate stripe; Choi, column 8, lines 40-41).
Choi et al. doesn’t teach the test line being at an angle of 75 degrees or less as well as the strip being configured such that a 1D scan, perpendicular to the direction of flow will pass through each test line. Choi et al. further fails to teach a plurality of control lines, each control line being associated with an adjacent test line and separated from the adjacent test line, where one control line is disposed between two adjacent test lines.
Schwind teaches a lateral-diagonal flow multi-parameter test (Schwind, column 1, lines 16-17). Schwind further teaches indicator zones that are configured in a row extending diagonally from the proximal to distal or vice versa and can be V, W-, M-, or N-shaped or reverse V, W-, M-, or N-shaped and staggered parallel side by side (Schwind, column 4, lines 2-7). Schwind further teaches that the indicator zone is formed by elongate or bandshaped indicator zones parallel side by side in defined X and Y positions (Schwind, column 13, lines 19-21 and Figure 13).
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(Schwind, Figure 13)
Put another way, Schwind teaches a lateral flow assay device with test lines arranged in a way that allows for a one-dimensional optical scan across the strip in a direction perpendicular to the direction of the flow to intersect all of the test lines. Schwind further teaches that the denotation of the results can be applied to the device according to the invention in a particularly practical and easily readable manner, because each parameter to be tested for occupies a defined X and Y position which can be considered as a coordinate system having an ordinate and an abscissa (Schwind, column 4, lines 11-20 and Figure 7). Schwind further teaches that the indicator zones comprise antibodies (Schwind, column 4, line 21) and that the lateral-diagonal flow multi-parameter test is for the simultaneous, qualitative or quantitative determination of a plurality of analytes in a liquid sample, including a membrane with an application zone (see (5) in Figure 7), at least two indicator zones (see (6) in figure 7) which are able to interact with the analyte(s) and at least one absorption region (see (3) in Figure 7) which absorbs the liquid after having passed the indicator zones (Schwind, column 1, lines 16-24).
O’Farrell teaches lateral flow assay devices that have two-dimensional features (O’Farrell, ‘Abstract’). O’Farrell further teaches the test line can be substantially parallel to the liquid flow direction (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45 degrees or more than 135 degrees). It can also be substantially perpendicular (more than 45 degrees or less than 135 degrees), including being completely perpendicular to the liquid sample flow direction (O’Farrell, column 10, line 53-column 11, line 4).
Lambotte teaches a lateral flow device capable of determining the presence and/or amounts of multiple analytes in a fluid sample. Lambotte further teaches that by positioning multiple test and/or control zones in predetermined patterns on the test device eliminates the need for an external test results panel or markings on a test device housing. Lambotte further teaches that in a preferred embodiment a single control zone is positioned between two test zones, each test zone testing for the presence or amount of a different analyte (Lambotte, column 2, lines 39-53, and Figure 1 a-c and f-g).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the test lines on the lateral flow device of Choi from perpendicular (as taught by Choi) to diagonal as taught by Schwind because of the teaching of Schwind that a diagonal arrangement offers the advantage that the denotation of the results can be applied to the device according to the invention in a particularly practical and easily readable manner.
It would have further been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the test lines as taught by Choi in view of Schwind to be at an angle of 75 degree or less as an obvious matter of a simple substitution of one art recognized lateral flow test line arrangement over another. The prior art contained the base invention (see as taught by Choi, the prior art already recognized a lateral flow device comprising conjugated rare earth phosphor particles). Further, at the time the prior art recognized the advantage of the diagonal arrangement of test lines in a lateral flow assay device (as in either Schwind or O’Farrell) and further it was recognized to specifically arrange them at an angel of 75 degree or less (as in O’Farrell). As such, it would have been obvious to modify the design format of Choi’s test strip to arrange the lines in a diagonal manner at an angle of 75 degree or less as one of ordinary skill in the art would appreciate one format is usable in place of the other, given that Schwind teaches success detecting analytes using diagonal test lines and O’Farrell teaches success using test lines at a wide range of angles including 75 degree or less. The results would have been predictable, namely in that both the arrangement of Choi and the diagonal arrangement as taught by Schwind and O’Farrell would be expected capable of multiplex detection as claimed. Furthermore, the modification is also considered as being obvious to try, namely considering there was a finite number of identified predictable solution regarding the diagonal arrangement of the test lines on a lateral flow device; see Schwind teaches a diagonal arrangement of test lines and O’Farrell teaches that the test lines can be more than 45 degrees or less than 135 degrees. One having ordinary skill in the art would have recognized that modifying the lateral flow test device of Choi by arranging diagonal test lines as taught by Schwind and O’Farrell would have predictably resulted in the detection of multiple antigen and as a result one would have had a reasonable expectation of success.
It would have further been obvious to have modified the device of Choi by positioning multiple test and/or control zones in predetermined patterns, such as a single control zone positioned between two test zones, as taught by Lambotte, because of the teaching of Lambotte that such positioning eliminates the need for an external test results panel or markings on a test device housing.
The ordinary artisan would have a reasonable expectation of success positioning the multiple test lines and multiple control lines so that a control line is disposed between to test lines as taught by Lambotte, because Choi, Schwind, O’Farrell and Lambotte all teach a similar multiplex lateral flow assay devices with multiple test lines.
Regarding claim 5, Choi teaches the plurality of test lines is configured in plurality of rows, including a first row and a second row (Choi, column 7, lines 60-64 and Fig. 2; test zone 1, 2,3, and control zone).
Regarding claim 6, Choi teaches that two types of reagents may be separately immobilized on the membrane as thin lines or bands and that the antibody that is specific to the conjugate antibody may be immobilized in the control window, while the antibody that is specific to an analyte is immobilized in the test window of the device comprising a case (Choi, column 8, lines 40-45 and see Figure 3). As such, Choi teaches that the rows are separated by a predetermined distance in the direction of flow, namely the appropriate distance for one line to appear in the test window and another in the control window of the device case.
Regarding claim 7, Choi and the cited art above teach a lateral flow assay test device, comprising a plurality of conjugated rare earth phosphor particles and a plurality of test lines arranged at an angle to the flow, substantially as claimed.
Choi fails to teach that the first row and second row are configured to be read by a 1-dimensional scanner.
As discussed previously in detail above, Schwind teaches a lateral-diagonal flow multi-parameter test (Schwind, column 1, lines 16-17). Schwind further teaches an embodiment where indicator zones that are configured staggered parallel side by side in a linear row (Schwind, column 4, lines 2-7). Schwind further teaches that the indicator zone is formed by elongate or bandshaped indicator zones parallel side by side in defined X and Y positions (Schwind, column 13, lines 19-21 and Figure 13). As such Schwind teaches a lateral flow device wherein the first and second row are configured to be read by a 1-dimensional scanner. Schwind further teaches that when each parameter to be tested for occupies a defined X and Y position it can be considered as a coordinate system having an ordinate and an abscissa with the advantage that the denotation of the results can be applied to the device according to the invention in a particularly practical and easily readable manner (Schwind, column 4, lines 11-20). Schwind further teaches that the lateral-diagonal flow multi-parameter test is for the simultaneous, qualitative or quantitative determination of a plurality of analytes in a liquid sample (Schwind, column 1, lines 16-19).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Choi so that the first and second row can be read by a one-dimensional scanner, for example staggered parallel, side by side as taught by Schwind because of the teaching of Schwind that these bandshaped indicator zones, parallel and sided by side, are in defined X and Y positions and that this allows for the denotation of the results in a particularly practical and easily readable manner.
The ordinary artisan would have a reasonable expectation of success in modifying the device of Choi by arranging the test lines staggered parallel, side by side because Choi and Schwind both teach a similar multiplex lateral flow assay device with multiple test lines.
Regarding claim 15, as discussed previously in detail above, the recitation of “wherein the test strip is configured for water quality testing” is directed to the intended use of the test strip and as such must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. However, in the current application, the prior art structure (the test strip) is capable of performing the intended use, i.e., using water as a sample. In this case, no clear structural differences are invoked by the recitation of the intended use as claimed. Because there is no distinction between the claimed structure and that of the cited prior art, it is the case that the multiplex lateral flow assay as taught by the prior art would similarly be expected capable of being used to test water quality. The limitation of the wherein clause at claim 15 fails to impart any particular structural feature or limitation and as such the prior art meets the limitations of the claim.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al., in view of Schwind et al.¸ O’Farrell et al., and Lambotte et al., as applied to claim 1 above, and further in view of Malamud et al. Point detection of pathogens in oral samples. Advances in Dental Research. 2005 Jun;18(1):12-6 (see PTO-892 03/12/2025).
Regarding claim 2, Choi and the cited art above teach a lateral flow assay test device, comprising a plurality of conjugated rare earth phosphor particles and test lines arranged at an angle to the flow, substantially as claimed.
Choi does not teach that the conjugated rare earth phosphor particle comprises an up-converting nanoparticle.
Malamud teaches a system that detects pathogen derived antigen, RNA, DNA, and host antibodies using a lateral flow strip with multiple test lines or capture zones (Malamud, page 12, 4th paragraph, lines 1-10, and figure 6). Malamud further teaches that the platform is based on up-converting Phosphor Technology, comprising phosphor particles (Malamud, page 12, 3rd paragraph, lines 1-4). Malamud further teaches that for antigen detection, the capture antibody is detected by up-converting phosphor particles conjugated with antibody (Malamud, page 13, Figure 1, legend, lines 5-6). Malamud further teaches that compared with gold, up-converting phosphor technology in lateral flow formats leads to 100-fold-improved sensitivity and this also allows for testing for the presence of more than one target in a single sample (Malamud, page 15, 2nd column, 2nd paragraph, lines 1-9). Malamud further teaches that since the up-conversion relies on combinations of lanthanide-containing crystals that do not exist in biological materials, sensitivity is high and the background is low (Malamud, page 12, 3rd paragraph, lines 5-8).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Choi by replacing the rare earth particles of Choi with the upconverting phosphor particles as taught by Malamud because of the teaching of Malamud that the upconverting phosphor particles result in a lateral flow strip device results in an assay with high sensitivity and low background.
One of ordinary skill in the art would have a reasonable expectation of success because Choi teaches success using rare earth phosphor particles to label captured analytes in a lateral flow device and Malamud teaches success labeling captured analytes with upconverting phosphor particles in a lateral flow device and as such one of ordinary skill in the art would expect success labeling captured analytes with up-converting phosphor particles in the device of Choi.
Regarding claim 14, Choi and the cited art above teaches a test strip substantially as claimed.
Choi does not teach a test strip shorter in the direction of flow than perpendicular to the direction of flow.
Malamud teaches nitrocellulose test strip, which is shorter in the direction of flow than perpendicular to the direction of flow, see, Figure 7 the sample application pad is attached to the nitrocellulose strip, which in turn is attached to an absorbent waste pad at the top of the strip (Malamud, page 15, Figure 7). As such Malamud teaches that the sample travels from the application pad on the bottom of the strip, through the strip to the waste pad and the test strip is oriented to be shorter in the direction of sample flow than perpendicular to the direction of flow. Malamud further teaches that multiple target-capture molecules can be aligned perpendicular or parallel to the flow and that perpendicular is preferred because it eliminates differences in signal intensity, since the distance from the sample pad to all capture zones is constant and it eliminates the requirement of the sample to pass through alternate capture zones. Therefore, potential interference of preceding target capture zones can be ignored in assay development (Malamud, page 14, ‘Multiple target capture zones: Trans-Dot strips’, see entire 2nd paragraph, Figure 6, and nitrocellulose strip in Figure 7).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the lateral flow test strip as taught by Choi to be oriented that the test strip is shorter in the direction of flow than perpendicular to the direction of flow because of the teaching of Malamud that this eliminates differences in signal intensity since the distance from sample pad to all capture zones is constant and the sample does not need to pass through alternate capture zones.
The ordinary artisan would have a reasonable expectation of success, because both Choi and Malamud teach a multiplex lateral flow assay device and because Malamud further teaches that multiple target-capture molecules can be aligned perpendicular or parallel to the flow of sample.
Response to Arguments
Applicant’s arguments, see page 6, 3rd paragraph, filed 09/08/2025, with respect to the rejections of claims 1-2, 5-7, and 14-15 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the argument that the 1-D scan clause is structural, not mere intended use.
Regarding the argument that the 1-D clause is structural and tied to explicit geometry, continuous lines at equal or less than 75 degrees, arranged in rows such that only that geometry enables a perpendicular single-pass 1-D scan to cross each line in a row, the combination of the prior art teaches a lateral flow assay as claimed. In particular, Schwind teaches a lateral flow assay with multiple lines arranged in parallel, along the direction of flow rather than perpendicular to it (see Schwind, Figure 13 above), so that a perpendicular one-dimensional scan would intersect all the test lines in the assay.
Applicant further argues on page 7 that O’Farrell teaches pixel and/or dots and not a continuous elongated stripe or line and that claim 1 now requires continuous elongated stripes, not a pixel or dot array, and that elongated stripes would render the devices inoperable without the ability for liquid to flow around the dots.
This argument is not persuasive.
As described previously in detail above, Schwind teaches test lines arranged in a way that allows for a perpendicular test scan to intersect all lines in a single scan line. O’Farrell is relied on to explicitly teach that test lines can be arranged at different angles, i.e. equal or less than 75 degrees. The layout of the test lines as taught by Schwind would not render the test lines/pixels of O’Farrell inoperable because the arrangement along or perpendicular to the flow of sample allows the sample to reach each test location without blocking flow to a subsequent test location.
Regarding the argument, that neither Lambotte nor Malamud teach the claimed angled line plus single scan geometry, neither are relied on to teach the test line geometry as claimed, but rather, as explained previously above, Schwind and O’Farrell teach angled, elongated, test stripes.
For all the reasons above, the arguments are not persuasive.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE J KIRWIN whose telephone number is (571)272-6574. The examiner can normally be reached Monday - Friday 7.30 - 4 pm.
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/STEFANIE J. KIRWIN/Examiner, Art Unit 1677
/Soren Harward/Primary Examiner, TC 1600
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