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 .
Response to Amendment
Applicant’s amendment filed on 09/03/25 has been entered. Claims 1, 6-11, 18-20, and 27-38 are pending and examined herein. Applicant’s amendment/remark have overcome each and every objection set forth in Office Action mailed on 05/30/25.
Status of Rejections and Objections
The objection of claim 32 is withdrawn in view of Applicant’s amendment.
The rejection of claim 27-28 under 35 U.S.C. 102(a)(2) in view of Kentsis (U.S. Pub. 2013/0338243 A1; cited in previous Office Action) is maintained.
The rejection of claim 29 under 35 U.S.C. 103 in view of Kentsis is maintained.
New ground of rejection is necessitated by Applicant’s amendment for claims 1, 6-11, 18-20, and 30-38 in view of Roswech (U.S. Pub. 2022/0146508 A1).
Claim Objections
Claim 33 is objected to because of the following informalities:
“Nearest the analyte pad” should be “Nearest to the analyte pad”
Appropriate correction is required.
Applicant is advised that should claim 1, 6, and 7 be found allowable, claims 33-35 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Kentsis.
Regarding claim 27, Kentsis discloses a lateral flow assay strip for testing a test sample (a dipstick immunological device; para. [0157]), comprising:
an analyte pad to receive the test sample ((1) a matrix (preferably filter paper) with diagnostic test reagents. Para. [0157]);
a test line at a first position on the LFA strip embedded with a first biological marker configured to bind with a chemical-of-interest present in the test sample, the test line configured to indicate a positive result when the chemical-of-interest being tested for is present in the test sample and a negative result when the chemical-of-interest being tested for is absent from the test sample; (a test device, such as a dipstick device has text on the device in two places. In one place the text indicates a positive result (i.e. the likelihood the subject has acute appendicitis)…Next to the positive indication is a matrix having diagnostic test reagents that react only with samples that have the presence of the test appendicitis biomarker, (e.g. LRG, or any or any combination of appendicitis biomarkers listed in Table 1) above a pre-defined level. Para. [0168]); and
a verification line at a second position on the LFA strip embedded with a second biological marker, the verification line configured to display a first color to indicate a positive result when a target marker for an expected substance, expected to be present when the chemical-of-interest is present, is on the LFA strip, and configured to display a second color to indicate a negative result when the target marker is not on the LFA strip (In another, it indicates a negative result (i.e. the likelihood the subject does not have acute appendicitis). Next to the indications are matrices having the appropriate diagnostic test reagents. For example, next to the negative indication is a matrix having diagnostic test reagents that react with all urine samples, regardless of the content of appendicitis biomarkers as disclosed herein. Para. [0168]), wherein the target marker is selected from urea (In one embodiment, the device has the negative indication (e.g., the “−” portion of a possible “+” symbol) containing reagents that reacts with all samples. That is, the diagnostic test reagents react to some constituent analyte, such as urea which is present in all urine samples. Para. [0167]).
Regarding claim 28, Kentsis discloses the claimed invention as discussed above in claim 27. Kentsis discloses the analyte pad is in liquid communication with the verification line and the test line (Initially before use, there is no visible band at position T and C of the test strip (FIG. 15B). When a fluid sample (e.g. urine) is place at the S position, the water in the urine rehydrates the dehydrated anti-biomarker protein antibody that has been deposited at S. Para. [0483]).
Claim(s) 30-31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Roswech.
Regarding claim 30 and 31, Roswech discloses a LFA, comprising:
an analyte pad to receive the test sample (sample pad 409, Fig. 4);
a test line at a first position on the LFA strip closest to the analyte pad embedded with a first biological marker configured to bind with a chemical-of-interest present in the test sample, the test line is configured to indicate a positive result when the chemical-of-interest being tested for is present in the test sample and a negative result when the chemical-of-interest being tested for is absent from the test sample (In certain embodiments, the lateral flow assay strip comprises a third sub-region (e.g., a test pad) comprising one or more test lines. In some embodiments, a first test line comprises a capture reagent (e.g., an immobilized antibody) configured to detect a first target nucleic acid sequence. Para. [0143]);
a verification line at a second position on embedded with a second biological marker (In certain embodiments, the lateral flow assay strip comprises one or more additional test lines. In some instances, each test line of the lateral flow assay strip is configured to detect a different target nucleic acid. Para. [0143]), the verification line configured to change to a first color to indicate a positive result when a target marker for an expected substance, expected to be present when the chemical-of-interest is present, is on the LFA strip and change to a second color to indicate a negative result when the target marker is absent (In certain embodiments, for example, a fluidic sample is exposed to a reagent that undergoes a color change when bound to a target nucleic acid (e.g., viral DNA or RNA), such as with an enzyme-linked immunoassay. In some embodiments, the assay further comprises a stop reagent, such as sulfonic acid. That is, when the fluidic sample is mixed with the reagents, the solution turns a specific color (e.g., red) if the target nucleic acid is present, and the sample is positive. If the solution turns a different color (e.g., green), the target nucleic acid is not present, and the sample is negative. Para. [0229]), wherein the analyte pad is in liquid communication with the verification line and the test line (para. [0139]).
The limitation regarding verifying an authenticity of the test sample or the presence of test sample is interpreted as recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention 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. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, the lines of the device of Roswech are used for indicating the presence of compound(s)/marker(s).
Claim Rejections - 35 USC § 103
Claim(s) 1, 6-11, 18-20, and 32-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roswech in view of Boehringer (U.S. Pub. 2008/0138842 A1), as evidenced by Jolly (U.S. Pub. 2022/0412961 A1).
Regarding claim 1, 6 and 11, Roswech discloses a lateral flow assay strip for testing a test sample, comprising:
an analyte pad to receive the test sample (sample pad 409, Fig. 4);
a test line at a first position on the LFA strip closest to the analyte pad embedded with a first biological marker configured to bind with a chemical-of-interest present in the test sample, the test line is configured to indicate a positive result when the chemical-of-interest being tested for is present in the test sample and a negative result when the chemical-of-interest being tested for is absent from the test sample (In certain embodiments, the lateral flow assay strip comprises a third sub-region (e.g., a test pad) comprising one or more test lines. In some embodiments, a first test line comprises a capture reagent (e.g., an immobilized antibody) configured to detect a first target nucleic acid sequence. Para. [0143]);
a verification line at a second position on embedded with a second biological marker (In certain embodiments, the lateral flow assay strip comprises one or more additional test lines. In some instances, each test line of the lateral flow assay strip is configured to detect a different target nucleic acid. Para. [0143]), the verification line configured to change to a first color to indicate a positive result when a target marker for an expected substance, expected to be present when the chemical-of-interest is present, is on the LFA strip and change to a second color to indicate a negative result when the target marker is absent (In certain embodiments, for example, a fluidic sample is exposed to a reagent that undergoes a color change when bound to a target nucleic acid (e.g., viral DNA or RNA), such as with an enzyme-linked immunoassay. In some embodiments, the assay further comprises a stop reagent, such as sulfonic acid. That is, when the fluidic sample is mixed with the reagents, the solution turns a specific color (e.g., red) if the target nucleic acid is present, and the sample is positive. If the solution turns a different color (e.g., green), the target nucleic acid is not present, and the sample is negative. Para. [0229]); and
a control line at a third position on the LFA stripto indicate a positive result when the test sample is present (para. [0144]), wherein the analyte pad is in liquid communication with the verification line, the test line, and the control line (para. [0139]);
Roswech does not disclose the control line is placed between the verification line and the test line.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claim 7, Modified Roswech discloses the claimed invention as discussed above in claim 1. Roswech does not disclose the test line is placed between the verification line and the analyte pad.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claims 8-10, Modified Roswech discloses the claimed invention as discussed above in claim 1. Roswech discloses the target marker is found in nasal cavity, urine, and mouth (Exemplary samples include bodily fluids (e.g. mucus, saliva, blood, serum, plasma, amniotic fluid, sputum, urine, cerebrospinal fluid, lymph, tear fluid, feces, or gastric fluid), para. [0158]).
Regarding claim 18-20, Modified Roswech discloses the claimed invention as discussed above in claim 1. Roswech does not explicitly disclose the verification line on the LFA strip changes conductivity in a presence of the target marker (claim 18), wherein the conductivity is proportional to a concentration of the target marker in the test sample (claim 19) or the conductivity is proportional to a concentration of the target marker in the test sample (claim 20). Roswech discloses the label particles used in the LFA are gold nanoparticles (In some embodiments, the fluidic sample is introduced to a first sub-region (e.g., a sample pad) of the lateral flow assay strip. In certain embodiments, the fluidic sample subsequently flows through a second sub-region (e.g., a particle conjugate pad) comprising a plurality of labeled particles. In some cases, the particles comprise gold nanoparticles (e.g., colloidal gold nanoparticles). The particles may be labeled with any suitable label. Para. [0224]). The function recited in claims 18-20 would have been an inherent property of gold nanoparticles label.
In an evidential reference, Jolly discloses a lateral flow test strip with gold nanoparticle label. Specifically, Jolly discloses the amount of nanoparticles accumulated (hence conductivity) are directly proportional to the increase in concentration (as more analytes of interest generally correlates increase in accumulation of nanoparticles in capture zone) (For example, a gold nanoparticle. In some embodiments the capture agent is attached to the nanoparticle and can be detected on the LFA at the capture zones 62. As the amount of nanoparticle accumulates, the intensity or contrast of the dot increases and can be distinguished spectroscopically or by eye. For example, some gold nanoparticles form a red spot with increasing intensity proportional to the accumulated concentration. Para. [0065]).
Therefore, Roswech, with support from Jolly, implicitly discloses the claimed function recited in claims 18-20.
Regarding claim 32, Roswech discloses the claimed invention as discussed above in claim 30. Roswech does not disclose the control line is placed between the verification line and the test line.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claim 33 and 34, Roswech discloses a lateral flow assay strip for testing a test sample, comprising:
an analyte pad to receive the test sample (sample pad 409, Fig. 4);
a test line at a first position on the LFA strip, nearest to the analyte pad, embedded with a first biological marker configured to bind with a chemical-of-interest present in the test sample, the test line is configured to indicate a positive result when the chemical-of-interest being tested for is present in the test sample and a negative result when the chemical-of-interest being tested for is absent from the test sample (In certain embodiments, the lateral flow assay strip comprises a third sub-region (e.g., a test pad) comprising one or more test lines. In some embodiments, a first test line comprises a capture reagent (e.g., an immobilized antibody) configured to detect a first target nucleic acid sequence. Para. [0143]);
a verification line at a second position on embedded with a second biological marker (In certain embodiments, the lateral flow assay strip comprises one or more additional test lines. In some instances, each test line of the lateral flow assay strip is configured to detect a different target nucleic acid. Para. [0143]), the verification line configured to change to a first color to indicate a positive result when a target marker for an expected substance, expected to be present when the chemical-of-interest is present, is in the test sample, and change to a second color to indicate a negative result when the target marker is absent (In certain embodiments, for example, a fluidic sample is exposed to a reagent that undergoes a color change when bound to a target nucleic acid (e.g., viral DNA or RNA), such as with an enzyme-linked immunoassay. In some embodiments, the assay further comprises a stop reagent, such as sulfonic acid. That is, when the fluidic sample is mixed with the reagents, the solution turns a specific color (e.g., red) if the target nucleic acid is present, and the sample is positive. If the solution turns a different color (e.g., green), the target nucleic acid is not present, and the sample is negative. Para. [0229]); and
a control line at a third position on the LFA stripto indicate a positive result when the test sample is present (para. [0144]), wherein the analyte pad is in liquid communication with the verification line, the test line, and the control line (para. [0139]).
The limitation regarding verifying an authenticity of the test sample or the presence of test sample is interpreted as recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention 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. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, the lines of the device of Roswech are used for indicating the presence of compound(s)/marker(s).
Roswech does not disclose the control line is placed between the verification line and the test line.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claim 35, Modified Roswech discloses the claimed invention as discussed above in claim 33. Roswech does not disclose the test line is placed between the verification line and the analyte pad.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claim 36 and 37, Roswech discloses a LFA strip for testing a test sample, comprising:
an analyte pad to receive the test sample (sample pad 409, Fig. 4);
a test line at a first position on the LFA strip closest to the analyte pad embedded with a first biological marker configured to bind with a chemical-of-interest present in the test sample, the test line is configured to indicate a positive result when the chemical-of-interest being tested for is present in the test sample and a negative result when the chemical-of-interest being tested for is absent from the test sample (In certain embodiments, the lateral flow assay strip comprises a third sub-region (e.g., a test pad) comprising one or more test lines. In some embodiments, a first test line comprises a capture reagent (e.g., an immobilized antibody) configured to detect a first target nucleic acid sequence. Para. [0143]);
a control line at a second position on the LFA strip to indicate a positive result when the test sample is present (para. [0144]);
a verification line at a third position on embedded with a second biological marker (In certain embodiments, the lateral flow assay strip comprises one or more additional test lines. In some instances, each test line of the lateral flow assay strip is configured to detect a different target nucleic acid. Para. [0143]), the verification configured to turn green to indicate a positive result when a target marker for an expected substance is present, and turn red to indicate a negative result when the target marker is absent (In certain embodiments, for example, a fluidic sample is exposed to a reagent that undergoes a color change when bound to a target nucleic acid (e.g., viral DNA or RNA), such as with an enzyme-linked immunoassay. In some embodiments, the assay further comprises a stop reagent, such as sulfonic acid. That is, when the fluidic sample is mixed with the reagents, the solution turns a specific color (e.g., red) if the target nucleic acid is present, and the sample is positive. If the solution turns a different color (e.g., green), the target nucleic acid is not present, and the sample is negative. Para. [0229]), wherein the analyte pad is in liquid communication with the verification line and the test line (para. [0139]).
The limitation regarding verifying an authenticity of the test sample or the presence of test sample is interpreted as recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention 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. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, the lines of the device of Roswech are used for indicating the presence of compound(s)/marker(s).
Roswech does not disclose the verification line is placed after the test line and control line.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Regarding claim 38, Modified Roswech discloses the claimed invention as discussed above in claim 36. Roswech does not disclose the test line is placed between the verification line and the analyte pad.
It is Examiner’s position that the claimed invention of claim 36 would have been an obvious rearrangement in parts of the device of Kentsis. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice. Without showing an unexpected result of placing the test line between the verification line and the analyte pad, the invention of claim 36 cannot be held non-obvious.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kentsis in view of Boehringer.
Regarding claim 29, Kentsis discloses the claimed invention as discussed above in claim 27. Kentsis does not disclose the test line is placed between the verification line and the analyte pad.
In an analogous art, Boehringer discloses that when detecting two or more different analytes within a single lateral flow test strip, separate test/capture lines and control lines can optionally be formed in the detection zone on the test strip for each analyte to be detected (para. [0100]).
It would have been obvious to one of ordinary skill in the art to have incorporated additional control line for each test line and/or verification line (hence deriving the configuration in which at least one of the control lines would be positioned in between the two test lines on the strip of Roswech based on the teaching of Boehringer. Having each of the plurality of control lines arranged after its corresponding test line can be used to prevent one test line/capture zone being confused with another (Alternatively, the same detectable marker can be used for all of the analytes. Alternatively, different detectable markers, as described above, can be used for the different analytes to prevent one capture zone being confused with another. Para. [0100]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 6-11, 18-20, and 30-38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 09/03/25 regarding the rejection of claims 27-29 have been fully considered but they are not persuasive. Specifically, applicant argues the device of Kentsis does not address having a first and a second color. The claim language “configured to display a first/second color” does not exclude a test strip having no color change (hence the test line remains blank/white) as being a first color. This is different from claim language “configured to change a first/second color”, which requires the line to display a color other than the default color of the test line (blank/white). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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