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.
Priority
This application is a U.S. National Stage (371) application of PCT/EP2022/087252 filed on 12/21/2022 which claims priority to Foreign Application No. DE10 2021 214 853.0 filed on 12/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/09/2024 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and all references are considered except where they were lined through.
Claim Objections
Claim 18 is objected to because of the following informalities: the claim recites “A method for analysing a sample for the content of an analyte (A) using a test strip (10) according to” and it is not clear what is “(10)” standing for. A possible correction is to delete (10) so that the claim recites “A method for analysing a sample for the content of an analyte (A) using a test strip according to”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hecht et al. (Microelectronic Engineering, 158 (2016) 52–58).
Claim 1 recites:
“A test strip comprising:
at least two spaced-apart flow paths of porous material on a common carrier,
each of the at least two spaced-apart flow paths comprising a first end in contact with a feed material and a reagent reservoir adjacent to the flow paths,
a detection area in each of the at least two spaced-apart flow paths between the first and an opposite second end,
a control area in each of the at least two spaced-apart flow paths between the detection area and the second end, wherein the reagent reservoir is subdivided into compartments, each of which is individually connected to one of the at least two spaced-apart flow paths, wherein each of the compartments or each of the at least two spaced-apart flow paths comprises a controllable barrier arranged to allow the sample to flow into each of the at least two spaced-apart flow paths after opening”.
Regarding claim 1, Hecht teaches a test strip with at least two spaced-apart flow paths of porous material on a common carrier (Abstract; page 53, left column, third paragraph, page 53, right column, second paragraph, “Specially engineered porous substrates and components for LFTs are commercially available”; page 53, left column, last paragraph; page 57, right column, third paragraph, “which leaves the porous membrane structure intact as well”). Hecht further teaches that each of the at least two spaced-apart flow paths comprising a first end in contact with a feed material and a reagent reservoir adjacent to the flow paths (Fig. 1, “Sample Application Pad”, “Conjugate Release Pad”; page 53, right column, sixth paragraph, “A fiberglass sample-application pad and conjugate release”; page 57, Fig. 7.4, “4-Parametric lateral flow test platform”, “Channels”). Hecht also teaches a detection area in each of the at least two spaced-apart flow paths between the first and an opposite second end (Page 53, Fig. 1, “Reaction-Zone”). And Hecht teaches a control area in each of the at least two spaced-apart flow paths between the detection area and the second end (Page 53, Fig. 1, “Control-Zone”). Hecht further teaches that the reagent reservoir is subdivided into compartments, each of which is individually connected to one of the at least two spaced-apart flow paths (Page 53, right column, first paragraph, “In the membrane strip the liquid is divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”). Hecht also teaches that each of the compartments or each of the at least two spaced-apart flow paths comprises a controllable barrier arranged to allow the sample to flow into each of the at least two spaced-apart flow paths after opening (Page 57, Fig. 7, “Barriers”, “100 μm air-“barrier” in between two nitrocellulose channels”).
Regarding claim 2, Hecht teaches that at least two of the compartments contain a different amount of an analyte and/or of a competitor of the analyte, and/or a different binding molecule which is specific for a different analyte, and/or a different amount of the binding molecule (Page 53, right column, first paragraph, “divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”).
Regarding claim 4, Hecht teaches that the barrier is a recess that extends over an entire cross-section of the compartments or of the flow path (Page 57, Fig. 7, “Barriers”, “100 μm air-“barrier” in between two nitrocellulose channels”).
Regarding claim 5, Hecht teaches that the recess extends into a range from 0 to 80% of a thickness of the carrier (Abstract, “By varying the laser parameters the presented method allows the rapid area-selective ablation of the entire membrane-thickness to the polyester backing thus creating a barrier for the fluid transport as well as a much finer, but slower, removal of the membrane material … With barrier and channel widths of 100 μm and 300–600 μm”).
Regarding claim 6, Hecht teaches that at least one of the compartments and/or at least one of the flow paths comprises a second reagent reservoir between the first end and the controllable barrier (Page 53, right column, first paragraph, “In the membrane strip the liquid is divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”).
Regarding claim 7, Hecht teaches that surfaces of side walls of the flow paths are impermeable to liquid (Page 57, left column, first paragraph, “for evaluating the barrier impermeableness”; page 57, right column, second paragraph, “No cross contamination between the channels by liquid wicking over the barriers could be observed”).
Regarding claim 8, Hecht teaches that the recess extends from a plane of a surface of the flow paths opposite the carrier with a tapered cross-section towards a plane of the carrier (Abstract; “By varying the laser parameters the presented method allows the rapid area-selective ablation of the entire membrane-thickness to the polyester backing thus creating a barrier for the fluid transport as well as a much finer, but slower, removal of the membrane material … With barrier and channel widths of 100 μm and 300–600 μm”; page 57, Fig. 7, “Barriers”, “100 μm air-“barrier” in between two nitrocellulose channels”).
Regarding claim 9, Hecht teaches that the recess extends in a plane of the surface of the flow paths opposite the carrier over a cross-section, the extent of which corresponds once to twice the thickness of the flow paths on the carrier (Abstract, “By varying the laser parameters the presented method allows the rapid area-selective ablation of the entire membrane-thickness to the polyester backing thus creating a barrier for the fluid transport as well as a much finer, but slower, removal of the membrane material … With barrier and channel widths of 100 μm and 300–600 μm”; Figure 7, “Barriers”, “Channels”, “100 μm air-“barrier” in between two nitrocellulose channels”).
Claims 18-19 and 22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hatamian et al. (US 2021/0285910 A1).
Claim 18 recites:
“A method for analysing sample for the content of an analyte (A) using a test strip (10) according to claim 1 comprising the steps of
applying the sample to the feed material,
incubating the test strip,
opening the barrier,
flowing the sample from the reagent reservoir into the flow paths,
detecting the label of the labelled binding molecule (B) bound m the detection area,
detecting the label of the labelled binding molecule (B) bound in the control area”.
Regarding claim 18, Hatamian teaches a method for analyzing a sample for the content of an analyte (A) using a test strip (Abstract). Hatamian further teaches applying the sample to the feed material [0103], [0169], [0177]. Hatamian also teaches incubating the test strip [0468]. And Hatamian teaches opening the barrier ([0063]; [0470]). Hatamian further teaches flowing the sample from the reagent reservoir into the flow paths [0068]. Hatamian also teaches detecting the label of the labelled binding molecule (B) bound in the detection area [0086]. And Hatamian teaches detecting the label of the labelled binding molecule (B) bound in the control area ([0005]; [0089]; [0093]; [0174]).
Regarding claim 19, Hatamian teaches opening the controllable barrier by contact with the sample or by bending the test strip about the recesses [0068].
Regarding claim 22, Hatamian teaches that at least one of the flow paths comprises a second reagent reservoir with a competitive antagonist of the analyte (A) ([0092]; [0096]).
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 (PHOSITA) 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hecht et al. (Microelectronic Engineering, 158 (2016) 52–58) as applied to claim 1 above, and further in view of Azpiroz et al. (US 2020/0376485 A1).
Claim 3 recites:
“The test strip according to claim 1, wherein the controllable barrier is formed as sugar, as wax, as salt, as polyvinyl alcohol, as polydimethylsiloxane, as a glass fibre mat inserted into a recess, as a section of cellulose inserted into a recess, as spiropyran-doped poly(DEAEMA-co-MMA), as a recess which can be overcome by an aqueous sample by applying an electric field, or as donor-acceptor stenhouse adducts and wax, or a combination of at least two of these”.
Regarding claim 3, the teachings of Hecht are previously discussed.
Regarding claim 3, Hecht does not teach that the controllable barrier is formed as sugar, as wax, as salt, as polyvinyl alcohol, as polydimethylsiloxane, as a glass fibre mat inserted into a recess, as a section of cellulose inserted into a recess, as spiropyran-doped poly(DEAEMA-co-MMA), as a recess which can be overcome by an aqueous sample by applying an electric field, or as donor-acceptor stenhouse adducts and wax, or a combination of at least two of these.
Regarding claim 3, Azpiroz teaches that the controllable barrier is formed as wax [0054].
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the controllable barriers of Azpiroz with the test strip of Hecht because Azpiroz noted such barriers achieve a more uniform sample distribution on the test strip [0054]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Azpiroz and Hecht based on the methods being in the field of making and using lateral flow test strips.
It would have been obvious for a PHOSITA to use the physical barriers of Azpiroz with the lateral flow test strips of Hecht to produce a test strip without any reagent overflow among the different channels.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hecht et al. (Microelectronic Engineering, 158 (2016) 52–58) as applied to claim 1 above, and further in view of Hatamian et al. (US 2021/0285910 A1).
Claim 10 recites:
“The test strip according to claim 1, wherein the reagent reservoir has a labelled binding molecule (B) specific for an Analyte (A), the detection area has an immobilised molecule which binds to the binding molecule (B) like the analyte (A), and the control area has an immobilised second antibody which is directed against the labelled binding molecule (B)”.
Regarding claim 10, the teachings of Hecht are previously discussed.
Moreover, regarding claim 10, Hecht teaches that the reagent reservoir has a labelled binding molecule (B) specific for an analyte (A) (Fig. 1, “Sample Application Pad”, “Conjugate Release Pad”; page 53, right column, sixth paragraph, “A fiberglass sample-application pad and conjugate release”; page 57, Fig. 7.4, “4-Parametric lateral flow test platform”, “Channels”).
Regarding claim 10, Hecht does not teach that the detection area has an immobilized molecule which binds to the binding molecule (B) like the analyte (A). Hecht also does not teach that the control area has an immobilized second antibody which is directed against the labelled binding molecule (B).
Regarding claim 10, Hatamian teaches that the detection area has an immobilized molecule which binds to the binding molecule (B) like the analyte (A) [0092]. Hatamian teaches that the control area has an immobilized second antibody which is directed against the labelled binding molecule (B) [0005].
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the immobilized analyte-like molecule of Hatamian with the test strip of Hecht because Hatamian noted that the immobilized analyte-like molecule confirms that the test has operated correctly regardless of whether the target analyte has been present in the sample [0092]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Hatamian and Hecht based on the methods being in the field of making and using lateral flow test strips.
It would have been obvious for a PHOSITA to use the immobilized analyte-like molecule of Hatamian with the lateral flow test strips of Hecht to verify the operational status of the test strip.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hecht et al. (Microelectronic Engineering, 158 (2016) 52–58) in view of Hatamian et al. (US 2021/0285910 A1).
Claim 11 recites:
“A method for producing a test strip according to claim 1, comprising the steps of
subdividing a porous material arranged on a carrier by laser irradiation into at least two flow paths separated from each other by a spacing, which flow paths extend from their first ends to their opposite second ends,
fusing of the surfaces of longitudinal sides of the flow paths to form a liquid-impermeable surface,
arranging a reagent reservoir having parallel spaced-apart compartments, with the compartments each at one of the flow paths,
producing a barrier in each of the compartments or in each of the flow paths,
arranging a reagent reservoir containing a labelled binding molecule (B)
in contact with the first end of each of the flow paths,
between the barrier and the second end of each flow path applying an immobilised molecule which binds to the binding molecule (B) like the analyte (A) to produce a detection area, between the detection area and the second end of each flow path arranging an immobilised second antibody directed against the labelled binding molecule (B) to produce a control area,
arranging a feed material in contact with the reagent reservoir and opposite the flow paths”.
Regarding claim 11, Hecht teaches a method for producing a test strip (Abstract). Hecht further teaches subdividing a porous material arranged on a carrier by laser irradiation into at least two flow paths separated from each other by a spacing, which flow paths extend from their first ends to their opposite second ends (Abstract; page 53, left column, second paragraph, “The purpose of this paper is therefore to investigate a fabrication method which locally removes nitrocellulose membrane material by means of ultrashort laser pulses”; page 57, Fig. 7, “4-Parametric lateral flow test platform based on a laser-structured nitrocellulose membrane”). Hecht also teaches fusing of the surfaces of longitudinal sides of the flow paths to form a liquid-impermeable surface (Pages 56, right column, last paragraph to page 57, left column, first paragraph, “The proposed multi-parametric LFT-platform shall make use of a similar laser pattern for the nitrocellulose membrane as in the test strips for evaluating the barrier impermeableness: consisting of 4 parallel isomorphic channels”). And Hecht teaches arranging a reagent reservoir having parallel spaced-apart compartments, with the compartments each at one of the flow paths (Page 53, right column, first paragraph, “In the membrane strip the liquid is divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”). Hecht further teaches producing a barrier in each of the compartments or in each of the flow paths (Page 57, Fig. 7, “Barriers”, “100 μm air-“barrier” in between two nitrocellulose channels”). Hecht also teaches arranging a reagent reservoir containing a labelled binding molecule (B) in contact with the first end of each of the flow paths, between the barrier and the second end of each flow path (Page 57, right column, first paragraph, “For the conjugate pad a 1:10 solution of the hCG-β antibody labelled with colloidal gold”). And Hecht teaches arranging a feed material in contact with the reagent reservoir and opposite the flow paths (Fig. 1, “Sample Application Pad”, “Conjugate Release Pad”; page 53, right column, sixth paragraph, “A fiberglass sample-application pad and conjugate release”; page 57, Fig. 7.4, “4-Parametric lateral flow test platform”, “Channels”).
Regarding claim 12, Hecht teaches that the reagent reservoir at its second end has compartments, each containing a different amount of an analyte, a different binding molecule specific for a different analyte, and/or of a different amount of the binding molecule, one compartment each being connected to one of the flow paths (Page 53, right column, first paragraph, “divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”; “With some small modifications it could also be feasible to use this design for a quantitative readout, by immobilizing different, precisely defined, amounts of the analyte in all but one the test channels”).
Regarding claim 11, Hecht does not teach applying an immobilized molecule which binds to the binding molecule (B) like the analyte (A) to produce a detection area, between the detection area and the second end of each flow path. Also, Hecht does not teach arranging an immobilized second antibody directed against the labelled binding molecule (B) to produce a control area.
Regarding claim 13, Hecht does not teach applying a competitive antagonist of the analyte (A) and/or the analyte (A) a second reagent reservoir between the first end of the flow paths and the barrier of at least one of the flow paths.
Regarding claim 11, Hatamian teaches applying an immobilized molecule which binds to the binding molecule (B) like the analyte (A) to produce a detection area, between the detection area and the second end of each flow path [0092]. Hatamian teaches arranging an immobilized second antibody directed against the labelled binding molecule (B) to produce a control area [0005].
Regarding claim 13, Hatamian teaches applying a competitive antagonist of the analyte (A) and/or the analyte (A) a second reagent reservoir between the first end of the flow paths and the barrier of at least one of the flow paths [0006-0007], [0092].
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the immobilized analyte-like molecule of Hatamian with the test strip of Hecht because Hatamian noted that the immobilized analyte-like molecule confirms that the test has operated correctly regardless of whether the target analyte has been present in the sample [0092]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Hatamian and Hecht based on the methods being in the field of making and using lateral flow test strips.
It would have been obvious for a PHOSITA to use the immobilized analyte-like molecule of Hatamian with the lateral flow test strips of Hecht to verify the operational status of the test strip.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hatamian et al. (US 2021/0285910 A1) as applied to claim 18 above, and further in view of Parolo et al. (Nature Protocols, Vol 15, December 2020, 3788-3816).
Claim 21 recites:
“The method according to claim 18, wherein the analyte (A) has exactly one epitope for an antibody”.
Regarding claim 21, the teachings of Hatamian are previously discussed.
Regarding claim 21, Hatamian does not teach that analyte (A) has exactly one epitope for an antibody.
Regarding claim 21, Parolo teaches that analyte (A) has exactly one epitope for an antibody (Page 3790, right column, last paragraph, “the monoclonal antibody should be the detection bioreceptor (it binds to just one epitope of the analyte)”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the monoclonal antibody of Parolo with the test strip of Hatamian because Parolo monoclonal antibody would not interfere with the binding of the detection antibody (Page 3790, right column, last paragraph). A PHOSITA would have had a reasonable expectation of success in combining the methods of Parolo and Hatamian based on the methods being in the field of making and using lateral flow test strips.
It would have been obvious for a PHOSITA to use the monoclonal antibody of Parolo with the lateral flow test strip of Hatamian to minimize the level of assay interference.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hatamian et al. (US 2021/0285910 A1) as applied to claim 18 above, and further in view of Hecht et al. (Microelectronic Engineering, 158 (2016) 52–58) and Foysal et al. (Sensors 2019, 19, 4812, pages 1-19).
Claim 23 recites:
“The method according to claim 18, wherein between the second end of the reagent reservoir, at least four compartments are arranged to each of which a different amount of an analyte and/or a competitive antagonist of the analyte is applied, the quotient of the signal determined for the label of the labelled binding molecule bound in the detection area (detection signal) and the signal determined for the label of the labelled binding molecule bound in the control area ( control signal) is determined, are calculated for each flow path as
quotient = detection signal/control signal, from which the logit values are calculated as logit value= ln(quotient/(1-quotient)), wherein in the event that quotient >1 the quotient is multiplied by a factor <1 in order to avoid a negative value for (1-quotient), the lo git values are plotted against the decadic logarithm of the quantities of the analyte or the competitive antagonist applied are added to a variable analyte concentration and, after a linear regression, the analyte content in the sample is determined as the minimum of the residual deviation”.
Regarding claim 23, the teachings of Hatamian are previously discussed.
Regarding claim 23, Hatamian does not teach that between the second end of the reagent reservoir, at least four compartments are arranged to each of which a different amount of an analyte and/or a competitive antagonist of the analyte is applied. Also, Hatamian does not teach the quotient of the signal determined for the label of the labelled binding molecule bound in the detection area (detection signal) and the signal determined for the label of the labelled binding molecule bound in the control area (control signal) is determined, are calculated for each flow path as quotient = detection signal/control signal. And Hatamian does not teach that from the quotient of the detection signal/control signal, the logit values are calculated as logit value= ln(quotient/(1-quotient)), wherein in the event that quotient >1 the quotient is multiplied by a factor <1 in order to avoid a negative value for (1-quotient), the logit values are plotted against the decadic logarithm of the quantities of the analyte or the competitive antagonist applied are added to a variable analyte concentration and, after a linear regression, the analyte content in the sample is determined as the minimum of the residual deviation.
Regarding claim 23, Hecht teaches that between the second end of the reagent reservoir, at least four compartments are arranged to each of which a different amount of an analyte and/or a competitive antagonist of the analyte is applied (Page 53, right column, first paragraph, “divided into multiple channels, each of which can be functionalized within detection and control zones for a different analyte”; “With some small modifications it could also be feasible to use this design for a quantitative readout, by immobilizing different, precisely defined, amounts of the analyte in all but one the test channels”).
Regarding claim 23, Foysal teaches the quotient of the signal determined for the label of the labelled binding molecule bound in the detection area (detection signal) and the signal determined for the label of the labelled binding molecule bound in the control area (control signal) is determined, are calculated for each flow path as quotient = detection signal/control signal (Page 8 of 19, “3.2.1. Input Parameter for Classification (Test to Control Line Signal Intensity (T/C) Ratio), The proposed method utilized a regression analysis [39,40] to approximate the analyte quantity and predict the value using machine learning techniques. As an input parameter for regression analysis, we considered the ratio of the test to control line signal intensity (T/C ratio), since the T/C ratio increase proportionally with analyte quantity despite of variation in illumination.”). Foysal also teaches calibration curves obtained from the regression analysis of the LFA sets in logarithmic and linear modes (Figure 15, (a), “Logarithmic”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the four compartments of Hecht with the test strip of Hatamian because Hecht’s compartments are functionalized to detect different analytes on the same strip (Page 53, right column, first paragraph). A skilled artisan would have been further motivated to combine the quantification approach of Foysal with the combined methods of Hecht and Hatamian because Foysal teaches how to quantify an analyte in an optimal way (Abstract). A PHOSITA would have had a reasonable expectation of success in combining the methods of Hecht, Foysal and Hatamian based on the methods being in the field of making and using lateral flow test-strips.
It would have been obvious for a PHOSITA to combine the four compartments of Hecht and the analyte quantification approach of Foysal with the lateral flow test strip of Hatamian to produce a quantitative multianalyte test strip.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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