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 .
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.
Withdrawn Rejections
The rejections of the claims under 112b are withdrawn in response to the amendments.
Priority
Acknowledgment is made of the present application as a proper National Stage (371) entry of PCT Application No. PCT/EP2021/064583, filed 05/31/2021, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 63/032,102, filed 05/29/2020.
Status of the Claims
Claims 23-27, 48-51, and 53-56 are pending; claims 49 and 51 are amended, claims 1-22, 28-47 and 52 are canceled; claim 56 is newly recited; Claims 23-27, 48-51, and 53-56 are examined below.
Information Disclosure Statement
The information disclosure statement filed 2/26/2026 and the information disclosure statement filed 9/3/2025 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms JAVA, JAVA SCRIPT and SWIFT in paragraph 60, which are a trade name or a mark used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they 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.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 23-27, 48-51 and 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over O'Farrell et al. (US 20120184462 A1) (Cite No. 1 of IDS 11/23/2022) ("O'Farrell").
Regarding claim 23, O’Farrell suggests a lateral flow assay device for use with a fluid sample (“The present invention relates to novel lateral flow devices” Abstract, “The function of the current lateral flow test device is based on capillary flow of liquids along the length of the test strip” para. 15), the device comprising: a conjugate pad including conjugates for a first target analyte (“When the test is run, this matrix must accept the conjugate and sample from the conjugate pad” para. 17, “a conjugate element that comprises a dried, labeled reagent, the labeled reagent being capable of moved by a liquid sample and/or a further liquid to the at least two of the reagent dots and/or a control location to generate a detectable signal…the labeled reagent binds to an analyte in the liquid sample” para. 134). Note that although O’Farrell fails to use the language “conjugates” the teaching of using the labeled reagent on at least two of the reagent dots and control locations inherently provides the use of multiple conjugates. O’Farrell further teaches a test grid including a plurality of zones in a two-dimensional grid (“Lateral flow devices using two dimensional features” Title, “uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices” Abstract, “a test device for detecting an analyte in a liquid sample, which device comprises a plurality of reagent dots on a matrix” para. 36, Figures 6-8), the test grid including: a first test zone in the plurality of zones including at least one of first immobilized antibodies or first immobilized antigens to attach to the target analyte labeled with a first conjugate of the conjugates; and a second test zone in the plurality of zones including at least one of second immobilized antibodies or second immobilized antigens to attach to the target analyte labeled with a second conjugate of the conjugates (“the signal(s) at the reagent dots are generated based on binding reactions involving the analyte, the reagents located at the reagent dots, …and/or other reagents dried on the test device before use and that are transported by the liquid sample …to the reagent dots” para. 105 “The reagents located at the reagent dots can be…antibody” para. 106). Note that although O’Farrell fails to use the language “first/second immobilized antibodies” and “first/second conjugate”, the teaching of antibody “dots on a matrix” generating a signal based on the binding of analyte and dried reagent (conjugate) inherently provides the use of at least two antibodies and two conjugates because O’Farrell teaches “a plurality of reagent dots on a matrix” which necessitates multiple antibodies and conjugates. O’Farrell further teaches wherein a location of the first test zone within the test grid and a location of the second test zone within the test grid is related to identifying information of the device (“the test device can comprise at least one group of the reagent dots that generate an additional signal… the additional signal can be used to indicate the authenticity, quality and/or identification of the test device” para. 126). Note that although O’Farrell fails to use the language “a location of the first test zone within the test grid and a location of the second test zone within the test grid” the teaching of “at least one group of the reagent dots” inherently provides a first and second location because the plurality of “dots” requires multiple locations. O’Farrell further teaches that “[l]ateral flow assays dominate the non-glucose rapid testing market in humans, and also other areas of application that require rapid generation of a test result, including veterinary diagnostics, agricultural testing, bio-warfare testing and food safety testing, as examples” (para. 3). O’Farrell further teaches that “[i]n many instances it is desirable to test for multiple reactions in a single sample (multiplexing)” (para. 5), “[f]or more demanding systems requiring…multiplexing… the current Lateral Flow system is inadequate” (para. 7), “[t]he present invention addresses these and other related needs” (para. 8).
O’Farrell fails to teach the device of claim 23 in a manner consistent with anticipation, i.e. there is some picking and choosing involved from the teachings of O’Farrell (see citations above). O’Farrell teaches the “conjugate pad” in paragraphs 17 and 134; the “test grid” in paragraphs 36, 105-106 and Figures 6-8; and “wherein a location of the first test zone within the test grid and a location of the second test zone within the test grid is related to identifying information of the device” in paragraph 126.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the conjugate pad from paragraphs 17 and 134, the test grid from paragraphs 36, 105-106 and Figs. 6-8, and “wherein a location of the first test zone within the test grid and a location of the second test zone within the test grid is related to identifying information of the device” from paragraph 126 of O'Farrell, thereby arriving at the claimed device, because O'Farrell suggests that this combination enables a lateral flow device that can multiplex and teaches that this is a desirable feature that is currently lacking in the field. One would therefore be motivated to combine the teachings of O’Farrell in order to provide a lateral flow device with multiplexing features. A person having ordinary skill in the art would have had a reasonable expectation of success given that O’Farrell teaches that lateral flow devices are very common and dominate the rapid assay market.
Regarding claim 24, O’Farrell suggests wherein the identifying information is included on a housing of the device (“Test Identification… Printing of alpha numeric information on strips that will only appear when the strip is developed. This code … may be visible elsewhere on the device. This can be used for anti counterfeiting, for QC or product identification purposes, or in applications that require verification of the strip identity (e.g., telephone or internet based diagnostics linked to prescription)” para. 181, “test device can further comprise a housing that covers at least a portion of the test device... the housing can cover the entire test device” paras. 138-139). Note that although O’Farrell fails to use the language “is included on a housing of the device” the teaching that the identifying information may be visible elsewhere, i.e. somewhere other than the strip, together with the teaching that the device comprises a housing, suggests that the identifying information of the device is included on the housing because the device is made up of the test strip and a housing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized from the teachings of O’Farrell that the identifying information of the device is included on a housing of the device because O’Farrell teaches a finite list of possible predictable solutions to the device design, thereby motivating a person having ordinary skill in the art to try including the identifying information of the device on the housing. A person having ordinary skill in the art would have had a reasonable expectation of success given that the device of O’Farrell appears to be solely made up of the test strip and the housing and O’Farrell teaches that lateral flow devices are very common and dominate the rapid assay market.
Regarding claim 25, O’Farrell suggests wherein the target analyte is a first target analyte, the conjugates are first conjugates, and the conjugate pad includes second conjugates for a second target analyte, wherein the test grid includes a third test zone in the plurality of zones including at least one of third immobilized antibodies or third immobilized antigens to attach to the second target analyte labeled with a conjugate of the second conjugates (“The test device can be used to detect a single analyte or multiple analytes in a liquid sample. In one example, the plurality of reagent dots in the test device comprises different reagents and the test device is used to detect multiple analytes in the liquid sample” para. 95, paras. 105-106, “FIG. 8 illustrates schematic of multiplex array (4 analyte ). Different binding reagents in each "channel" allows for multiplexing of analyte detection” para. 49, see Figure 8). Note that although O’Farrell fails to use the language “second conjugates for a second target analyte”, “a third zone” and “third immobilized antibodies to attach to the second target analyte labeled with a conjugate of the second conjugates”, the teaching of using different antibody “dots” in a multiplex array for multiple analyte detection together with Figure 8 showing “different binding reagents in each “channel”” (Fig. 8), inherently provides “second conjugates for a second target analyte”, “a third zone” and “third immobilized antibodies to attach to the second target analyte labeled with a conjugate of the second conjugates” because a multiplex array of different antibody dots necessitates both second conjugates and a third zone with immobilized antibodies to attach to the second target analyte labeled with a conjugate of the second conjugates.
Regarding claim 26, O’Farrell suggests wherein the test grid includes a control zone in the plurality of zones including at least one of third immobilized antibodies or third immobilized antigens to attach to conjugates not bound to the target analyte (Abstract, para. 106, “After the liquid sample flows laterally along the test device, the reagent dots in one of the lines generate a signal indicating the presence and/or amount of an analyte in the liquid sample, and the reagent dots in the other line generate a control signal indicating the test is properly conducted” para. 122, “a control location comprising means for indicating proper flow of the liquid sample and/or a valid test result. Any suitable means can be used... In another example, the means comprises a binding reagent that binds to a binding reagent with a detectable label that does not bind to the analyte” para. 131).
Regarding claim 27, O’Farrell suggests wherein the test grid includes a blank zone in the plurality of zones that does not include immobilized antibodies or immobilized antigens (“The reagent dots can have any suitable space(s) or distance(s) between or among the dots” para. 102). Note that the space or distance between the reagent dots are reasonably interpreted as a blank zone that does not include immobilized antibodies or immobilized antigens.
Regarding claim 48, O’Farrell suggests wherein the target analyte is a first target analyte, the conjugates are first conjugates, and the conjugate pad includes second conjugates for a second target analyte (paras. 95, 105-106, Fig. 8), wherein the first test zone is at a first row and a first column of the test grid and the second test zone is at a second row and the first column of the test grid (Figure 8). Note that figure 8 shows the first test zone at a first row and a first column of the test grid and the second test zone at a second row and the first column of the test grid, i.e. the “channels” of O’Farrell are interpreted here as columns (“Different binding reagents in each “channel” allows for multiplexing of analyte detection” FIG. 8).
Regarding claim 49, O’Farrell suggests wherein the test grid further includes: a third test zone in the plurality of zones at a second row and a second column of the test grid, the third test zone including at least one of third immobilized antibodies or third immobilized antigens to attach to the first target analyte labeled with one of the first conjugates (“FIG. 7 illustrates schematic of 2-dimensional quantification array. Binding reagent is deposited in the flow path as pixels in two dimensions. The concentration of the binding reagent is the same in all pixels in the direction of flow, but the concentration changes in each row perpendicular to the direction of flow. The system acts to quantify in the same manner as in FIG. 6, however, the titration of the binding reagent in the second dimension allows for the generation of a greater dynamic range in the assay” para. 48, see Figures 6-7 showing a grid of reagent spots for an analyte, paras. 105-106 and 136); and a fourth test zone in the plurality of zones at the first row and the second column of the test grid, the fourth test zone including at least one of fourth immobilized antibodies or fourth immobilized antigens to attach to the second target analyte labeled with one of the second conjugates (“Different binding reagents in each “channel” allows for multiplexing of analyte detection” FIG. 8, paras. 49 and 95). Note that O’Farrell’s “channels” of Fig. 8 are interpreted here as the claimed columns (as was done for claim 48 above), and the lines of different binding reagents perpendicular to the columns in O’Farrell’s Fig. 8 are the claimed rows. Note also that O’Farrell teaches that “the titration of the binding reagent in the second dimension allows for the generation of a greater dynamic range in the assay” (para. 48) with regards to the third zone at a second row and a second column of the test grid (Figs. 6-7). O’Farrell further teaches that “[t]he predetermined pattern formed at the reagent dots can take any form, shape and/or pattern” (para. 93). O’Farrell further teaches that “[d]emand for multiplexed systems, where detection of more than one analyte is necessary in the same test system is also developing” (para. 6).
O’Farrell teaches the third test zone at a second row and a second column of the test grid in Figures 6-7, drawn to an embodiment regarding the titration of the binding reagent and teaches a fourth test zone in the plurality of zones at the first row and the second column of the test grid, the fourth test zone including at least one of fourth immobilized antibodies or fourth immobilized antigens to attach to the second target analyte labeled with the second conjugate of the conjugates in Figure 8 drawn to an embodiment regarding analyte multiplexing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined different embodiments from O’Farrell, i.e. the third test zone at a second row and a second column of the test grid, the third test zone including at least one of third immobilized antibodies or third immobilized antigens to attach to the first target analyte labeled with the first conjugate of the conjugates from Figures 6-7 of O’Farrell with the fourth test zone in the plurality of zones at the first row and the second column of the test grid, the fourth test zone including at least one of fourth immobilized antibodies or fourth immobilized antigens to attach to the second target analyte labeled with the second conjugate of the conjugates from Figure 8 of O’Farrell because O'Farrell suggests that the third zone enables a greater dynamic range in the assay and the fourth zone enables multiplexing. Therefore, one would have been motivated to combine these embodiments in order to obtain the benefits of greater dynamic range for a target analyte and analyte multiplexing, which O’Farrell teaches is in developing demand. A person having ordinary skill in the art would have had a reasonable expectation of success because O’Farrell teaches that the grid pattern of the device is not limited and the grid can take any form, shape and/or pattern and O’Farrell teaches that lateral flow devices are very common and dominate the rapid assay market (para. 3).
Regarding claim 50, O’Farrell suggests wherein the test grid includes at least two spatially distinct rows with at least two spatially distinct columns (Fig. 8).
Regarding claim 51, O’Farrell suggests a lateral flow assay device (Abstract) comprising: a conjugate pad (paras. 17 and 134) including conjugates for a first target analyte and a second target analyte (para. 95, paras. 105-106, Fig. 8); and a test grid including a plurality of zones in a two-dimensional grid (Title, para. 36, Fig. 8), the test grid including: a first test zone in the plurality of zones at a first row and a first column of the test grid, the first test zone including at least one of first immobilized antibodies or first immobilized antigens to attach to the first target analyte labeled with a first conjugate of the conjugates; and a second test zone in the plurality of zones at a second row and the first column including at least one of second immobilized antibodies or second immobilized antigens to attach to the second target analyte different than the first target analyte, the second target analyte labeled with a second conjugate of the conjugates (para. 95, paras. 105-106, Figure 8). Note that O’Farrell also addresses claim 51 because the “channels” of O’Farrell’s Figure 8 (going along the length of the strip) can be interpreted as the claimed rows, and the different binding reagents along the width of the strip can be interpreted as the claimed columns given that the claimed rows and columns are not limited to a particular orientation along the test strip. Therefore, Figure 8 of O’Farrell teaches a first antibody in a first row and first column and a second antibody in a second row and first column (see Fig. 8 showing different binding reagents aligned along the width of the strip). O’Farrell further suggests wherein a position of the first test zone and a position of the second test zone in the test grid are based on test device identification information (para. 126). O’Farrell further suggests that the test grid of reagent dots enables also the formation of patterns, e.g. “a symbol, a geometric shape and an alpha-numeric shape, a regular shape, or a irregular shape, or a combination thereof… alpha-numeric shape can be a letter, a word, a number or a combination thereof” (para. 93), which “can indicate a kinetic property of the binding between the antigen and the antibody” (para. 125). O’Farrell further teaches that lateral flow devices are very common and dominate the rapid assay market (para. 3).
O’Farrell fails to teach the device of claim 51 in a manner consistent with anticipation, i.e. there is some picking and choosing involved from the teachings of O’Farrell (see citations above). For example, O’Farrell teaches the “conjugate pad” in paragraphs 17 and 134; the “test grid” in paragraphs 36, 95, 105-106 and Figure 8; and “wherein a location of the first test zone within the test grid and a location of the second test zone within the test grid is related to identifying information of the device” in paragraph 126.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the conjugate pad from paragraphs 17 and 134, the test grid from paragraphs 36, 95, 105-106 and Fig. 8, and “wherein a location of the first test zone within the test grid and a location of the second test zone within the test grid is related to identifying information of the device” from paragraph 126 of O'Farrell, thereby arriving at the claimed device, because O'Farrell suggests that this combination enables a lateral flow device that can generate a pattern within the test grid that can provide information regarding the binding kinetics between the antigen and antibody. One would therefore be motivated to combine the teachings of O’Farrell in order to provide a lateral flow device with useful patterning features. A person having ordinary skill in the art would have had a reasonable expectation of success given that O’Farrell teaches that lateral flow devices are very common and dominate the rapid assay market.
Regarding claim 53, O’Farrell suggests wherein the identifying information is included on a housing of the lateral flow assay device (paras. 88, 126, 181, and 138-139). Note that O’Farrell suggests that the reagent dot pattern can provide a signal that can identify the test device (para. 126), and that this signal may be “visible elsewhere on the device” (para. 181) which reads on the claim. Although O’Farrell fails to use the language “identifying information of the test grid”, the teaching of “lateral flow assay using two dimensional features” (Title) and that the “reagent dots form a predetermined pattern” (para. 88) suggest that the pattern is an identifying feature of the device. Therefore, identifying information of the device inherently suggests identifying information of the test grid. Note also that although O’Farrell fails to use the language “is included on a housing of the device” the teaching that the identifying information of the device may be visible elsewhere, i.e. somewhere other than the strip, together with the teaching that the device comprises a housing, suggests that the identifying information of the device (and test grid) is included on the housing because the device is made up of the test strip (and predetermined pattern or grid) and a housing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized from the teachings of O’Farrell that the identifying information of the device “included elsewhere” encompassed identifying information of the test grid on a housing of the device because O’Farrell teaches a finite list of possible predictable solutions to the device design, thereby motivating a person having ordinary skill in the art to try including the identifying information of the test grid on the housing. A person having ordinary skill in the art would have had a reasonable expectation of success given that the device of O’Farrell appears to be solely made up of the test strip and the housing and teaches that lateral flow devices are very common and dominate the rapid assay market (para. 3). Furthermore, O’Farrell teaches that the “test identification…code…may be visible elsewhere…can be used for anti counterfeiting, for QC or product identification purposes, or in applications that require verification of the strip identity (e.g., telephone or internet based diagnostics linked to prescription)” (para. 181) which reads on “identifying information of the test grid on a housing of the device”.
Regarding claim 54, O’Farrell suggests wherein the test grid includes at least two spatially distinct rows with at least two spatially distinct columns (Fig. 8).
Regarding claim 55, O’Farrell suggests wherein the test grid includes a control zone in the plurality of zones including at least one of third immobilized antibodies or third immobilized antigens to attach to conjugates not bound to the target analyte (Abstract, para. 106, para. 122, para. 131).
Regarding claim 56, O’Farrell suggests wherein the test grid includes a blank zone in the plurality of zones that does not include immobilized antibodies or immobilized antigens (para. 102).
Response to Arguments
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive.
Regarding the 103 rejections, Applicant argues that “The portion of the test strip in O'Farrell that provides identification information is explicitly described in O'Farrell as separate from the analyte testing (i.e., "not related to the presence, absence and/or amount of the analyte in the liquid sample"). Therefore, O'Farrell does not describe a device with a test grid in which a location of a first test zone and a second test zone within the test grid is related to identifying information of the device” (page 7 para. 5 and page 8 para. 1). However, "not related to the presence, absence and/or amount of the analyte in the liquid sample" does not mean “separate from the analyte testing”. Given that O’Farrell teaches that a group of reagent dots provides identification of the test device, the claim is obvious over O’Farrell (see rejection above).
Conclusion
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.
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/Fernando Ivich/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678