The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 19, 2025 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 6-7, 9-20 are canceled. Claims 1-5, 8, 21-38, 39-42 are under consideration.
Priority: This application claims benefit of provisional applications 62/877188, filed July 22, 2019, and 63/040159, filed June 17, 2020.
Objections and Rejections
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.
Claims 1-2, 4-5, 8, 21, 28-30, 32-38, 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (US 20050255453; previously cited) in view of Taniguchi et al. (US 20070154976; previously cited) and Depa et al. (WO 2019152508; previously cited), and evidenced by Ferri et al. (2009 Journal of Diabetes Science and Technology 3(3): 585-592; previously cited).
Qian et al. disclose an assay for quantitating glycated protein, the assay comprising multilayer reagent test strips, where the reagent test strips include a plurality of different layers, where the layers are in sequential fluid communication (at least paragraph 0024). Qian et al. disclose the distinct layers range from about 2 to 10, usually 3 to 7, including a minimum of three layers in sequential order a blood filter layer, a protease layer, and a ketoamine oxidase signal producing layer (at least paragraph 0025). Qian et al. disclose the layers are polymers comprising porous matrices (at least paragraph 0056), where it is known polymers comprise cross-linked chains (at least paragraph 0040), where the protease layer comprises a protease enzyme (at least paragraph 0056-0057), the signal producing layer comprises a ketoamine oxidase, an indicator dye (detection agent), a peroxidase enzyme (at least paragraphs 0059-0064). Qian et al. disclose that agents to remove interference can also be included in the matrix (at least paragraph 0046). Qian et al. also disclose that the multiple layers of the polymers or porous matrices can comprise a buffered solution (at least paragraph 0041). As noted above, Qian et al. disclose that one or more additional layers that provide for additional functionality are also present (at least paragraph 0025), where additional layers include additional polymeric layers (at least paragraphs 0077-0079). Qian et al. also disclose in the art, ketoamines are generally known as “fructosamines” (at least paragraph 0006). Therefore, Qian et al. can reasonably be deemed to disclose an assay comprising a stack of film layers comprising from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a ketoamine oxidase (or fructosyl oxidase), an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel); and a third film layer comprising a protease. Qian et al. do not explicitly teach a lysing agent and denaturing agent in the protease layer.
Taniguchi et al. disclose reagents for determining a substrate in a hemoglobin-containing sample, the substrate being glycated hemoglobin (at least abstract, paragraphs 0003, 0020). Taniguchi et al. disclose a surfactant, i.e. Triton X-100, can be used in combination with other anionic surfactants (at least paragraph 0040) with whole blood samples, and in combination with protease (at least paragraph 0044), where protease acts to release glycated amino acid from hemoglobin A1c (at least paragraph 0038), and its action is combined with the surfactants used for hemolysis (at least paragraph 0044). Taniguchi et al. disclose the oxidase include fructosyl amino acid oxidase, ketoamine oxidase, fructosyl peptide oxidase (at least paragraph 0032). Taniguchi et al. also disclose that the oxidase is used in combination with another enzyme for treating interfering substance (at least paragraph 0034). Taniguchi et al. disclose a first reagent comprising the surfactants for hemolysis and a second reagent comprising fructosyl peptide oxidase, peroxidase, TPM-PS (at least examples). The fructosyl peptide oxidase acts on fructosyl valylhistidine or fructosyl valine (at least paragraph 0041). Taniguchi et al. disclose the reagent can be provided in dry or gel form; may be placed in a glass vial, etc. or applied to or impregnated into an insoluble carrier; insoluble carriers include particle/sphere carriers such as latex, glass, and colloid; flat plate carriers such as semiconductor and glass; film-like carriers (at least paragraph 0049).
Depa et al. disclose a test strip comprising multiple film layers for measuring analytes, where the analyte comprises glycated hemoglobin (at least abstract). Depa et al. disclose that any layer underneath a porous layer when it is wetted becomes semi-transparent, and the layer underneath is colored, could potentially interfere with the optical apparatus during analysis with the optical measuring apparatus (at least p. 7 lines 13-15). Depa et al. disclose impregnating into the layer a filler or whitening agent such as titanium oxide to provide opacity to reduce background signal for a better reflectance signal and test accuracy for the optical measuring apparatus (at least p. 7 lines 15-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed slide comprising a stack of film layers, from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a fructosyl oxidase that is specific for Fru-ValHis peptide or a glycated amino acid, an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel) for additional functionality including minimizing interference comprising a buffered solution; and a third film layer comprising a lysing agent (Triton X-100), a denaturing agent (anionic surfactant), and a protease (instant claims 1-2, 21, 34-36). The motivation to do so is given by Taniguchi et al., which disclose that Triton X-100 (lysing agent) and an anionic surfactant (denaturing agent) can be combined with protease in a reagent to release hemoglobin, hemoglobin A1c, and hemoglobin A1c specific glycated peptide from the blood sample. Therefore, one of ordinary skill would have a reasonable motivation to incorporate the Triton X-100 and anion surfactant disclosed in Taniguchi et al. in the protease layer of the assay comprising a stack of film layers of Qian et al., thereby arriving at the claimed invention. One of ordinary skill would have a reasonable expectation of success because an assay for measuring glycated hemoglobin comprising multilayer reagent strips was disclosed in the prior art and the reagents for measuring glycated hemoglobin were also known.
Regarding the limitation that the second layer comprising the polymeric matrix (gel) or hardened gel comprises at least one buffer and a reflective material portion comprising titanium dioxide (instant claim 1), as noted above, Depa et al. disclose that any layer underneath a porous layer when it is wetted becomes semi-transparent, and the layer underneath is colored, could potentially interfere with the optical apparatus during analysis with the optical measuring apparatus (at least p. 7 lines 13-15). Depa et al. disclose impregnating into the layer a filler or whitening agent such as titanium oxide to provide opacity to reduce background signal for a better reflectance signal and test accuracy for the optical measuring apparatus (at least p. 7 lines 15-18). As also noted, Qian et al. also disclose that the multiple layers of the polymers or porous matrices can comprise a buffered solution (at least paragraph 0041); in addition, agents to remove interference can also be included in the matrix (at least paragraph 0046). Qian et al. disclose that one or more additional layers that provide for additional functionality are also present (at least paragraph 0025), where additional layers include additional polymeric layers (at least paragraphs 0077-0079). Qian et al. disclose the matrix material is one that is porous and provides for flow of sample fluid through the material; a number of different porous matrices have been developed and are available; where the matrix may have a porosity gradient, with larger pores near or at the sample application region and smaller pores at the detection region (at least paragraph 0056). Therefore, it would have been obvious to one of ordinary skill in the art to incorporate a layer comprising titanium oxide as suggested in Depa et al. and a buffered solution as suggested in Qian et al. into the assay comprising a stack of film layers, such as a layer comprising a polymeric matrix (or hardened gel) having a porosity gradient that allows the smaller molecules for detection (fructosyl valylhistidine) to flow through to the detection region while excluding the larger molecular weight biomolecules to flow through to the detection region, where the noted layer is above the layer comprising the cross-linked polymeric matrix (or gel) comprising the detection agent, fructosyl oxidase, agent that prevents interference, and peroxidase enzyme disclosed in the multi-layer assay of Qian et al. and Taniguchi et al. noted above (instant claim 1) because doing so would reduce background signal for a better reflectance signal and test accuracy. Since Depa et al. suggest incorporating a reflective material (titanium oxide) that is materially the same and has the same functional purpose as the recited reflective material and Qian et al. disclose materially the same polymers or polymeric matrices for incorporating into a multiple layer assay may be optimized to have a porosity gradient with larger pores near or at the sample application region and smaller pores at the detection region, it would be obvious that the noted layer comprising a polymeric matrix (or hardened gel) for additional functionality comprising titanium oxide as suggested in Depa et al. and a buffered solution as suggested in Qian et al. above can be optimized to have a porosity that allows the smaller molecules for detection (fructosyl valylhistidine) to flow through to the detection region while excluding the larger molecular weight biomolecules to flow through to the detection region.
Regarding instant claim 4, Qian et al. disclose the protease is any convenient protease, including proteinase K, chymotrypsin, trypsin, and the like (at least paragraph 0057).
Regarding instant claims 5, 30, Qian et al. disclose the indicator dye is DA-67 (at least paragraph 0073) and Taniguchi et al. also disclose the color producing compound is DA-67 (at least paragraph 0035).
Regarding instant claims 5, 28, 29, Taniguchi et al. disclose the color producing compound is also selected from DA-64, TPM-PS (at least paragraph 0035).
Regrading instant claims 8, 33, Qian et al. disclose the polymer matrices are porous (at least paragraph 0056). Qian et al. disclose pore sizes in multilayer reagent strips include among others about 30 µm (at least paragraph 0053). Taniguchi et al. also disclose the reagent can be immobilize in an insoluble carrier, including particle/sphere carriers such as latex (at least paragraph 0049). Therefore, it would be obvious that the protease layer in the multilayer reagent strips noted above can comprise a layer with particles, where the particles have a diameter of about 25 µm, because the prior art discloses the polymeric layers comprise pores and/or particles having sizes similar to the claimed particle diameters. Additionally, regarding instant claim 33, Taniguchi et al. disclose particles carriers such as latex (at least paragraph 0049).
Regarding instant claim 32, Taniguchi et al. disclose an interference prevention agent is ascorbic acid oxidase (at least paragraph 0034).
Regarding instant claims 34-36, as noted above, Taniguchi et al. disclose the fructosyl peptide oxidase acts on fructosyl valylhistidine or fructosyl valine (at least paragraph 0041).
Regarding instant claims 37-38, it is known that fructosyl oxidase enzymes have a FAD cofactor (evidenced by Ferri et al. p. 586-587). Further, Taniguchi et al. has disclosed that in methods for determining glycated hemoglobin, the presence of a surfactant helps to reduce interference of hemoglobin which coexists in the sample (at least paragraph 0020). Taniguchi et al. disclose incorporating a surfactant with a protease in a reagent to release glycated peptide or amino acid from the glycated hemoglobin and then the release glycated peptide/amino acid is further treated with fructosyl peptide oxidase or fructosyl amino acid oxidase, i.e. in steps i-iii (at least paragraphs 0038-0041). Taniguchi et al. disclose that the steps including i-iii may be performed sequentially or simultaneously (at least paragraph 0044); therefore, it would be obvious that the layer comprising a fructosyl oxidase of Qian et al./Taniguchi et al. in the 103 rejection above has a FAD cofactor and can further be incorporated with a surfactant.
Regarding instant claims 39-42, Qian et al. disclose an upper guard piece and a support element above the blood separation and protease layers and a support element below the fructosyl oxidase bottom layer and polymer layers (at least paragraphs 0080-0085, see also Fig. 1).
Reply: Applicants’ amendments/remarks have been considered but they are not persuasive. The reasons for maintaining the 103 rejection are the same as previously noted and are incorporated herein.
Applicants assert that the office cites Depa et al. for its disclosure of a reflective material to remedy the deficiencies of Qian et al. and Taniguchi et al. Applicants assert that however, Depa et al. do not teach a second film layer comprising a hardened gel, at least one buffer, and a reflective material portion comprising titanium dioxide…wherein the hardened gel and the titanium oxide are combined in such a manner to create a sieve for Fru-α-ValHis to pass through the second film layer while excluding larger molecular weight proteins from pass through the second film layer. Applicants assert that Depa et al.’s porous membrane (which the examiner equates to the subject application’s second film layer) does not include at least one buffer and a hardened gel, rather Depa et al. utilizes a porous membrane. Applicants assert that Depa et al. make no mention of whether its porous membrane is a hardened gel.
Applicants’ remarks are not persuasive. Firstly, it is noted that the porous membrane of Depa et a. is not being relied upon for the materials of the multilayer assay. Depa et al. is being relied upon to incorporate a titanium dioxide material into a film layer comprising a polymeric matrix (or gel) for additional functionality in the multilayer reagent test strips in the assay of Qian et al. and Taniguchi et al. noted above.
The instant specification discloses that the hardened gel is a gel layer (at least paragraph 0127).
As noted in the 103 rejection above, Qian et al. disclose an assay comprising a stack of film layers comprising from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a ketoamine oxidase (or fructosyl oxidase), an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel); and a third film layer comprising a protease.
Qian et al. disclose that the multiple layers of the polymers or porous matrices can comprise a buffered solution (at least paragraph 0041); in addition, agents to remove interference can also be included in the matrix (at least paragraph 0046). Qian et al. disclose that one or more additional layers that provide for additional functionality are also present (at least paragraph 0025), where additional layers include additional polymeric layers (at least paragraphs 0077-0079). Qian et al. disclose the matrix material is one that is porous and provides for flow of sample fluid through the material; a number of different porous matrices have been developed and are available; where the matrix may have a porosity gradient, with larger pores near or at the sample application region and smaller pores at the detection region (at least paragraph 0056).
As previously noted, Depa et al. disclose a test strip having multiple film layers for measuring analytes, including the glycated hemoglobin of Qian et al./Taniguchi et al. (Depa et al. abstract). Depa et al. disclose that any layer underneath a porous layer when it is wetted becomes semi-transparent, and the layer underneath is colored, could potentially interfere with the optical apparatus during analysis with the optical measuring apparatus (at least p. 7 lines 13-15). Depa et al. disclose impregnating into the layer a filler or whitening agent such as titanium oxide to provide opacity to reduce background signal for a better reflectance signal and test accuracy for the optical measuring apparatus (at least p. 7 lines 15-18).
In the multilayer assay of Qian et al. and Taniguchi et al. above, the blood sample flows through the protease layer before reaching the fructosyl oxidase bottom layer (see above). Qian et al. disclose that one or more additional layers that provide for additional functionality are also present (at least paragraph 0025).
Therefore, it would have been obvious to one of ordinary skill in the art to incorporate a layer comprising titanium oxide as suggested in Depa et al. and a buffered solution as suggested in Qian et al. into the assay comprising a stack of film layers, such as a layer comprising a polymeric matrix (or hardened gel) having a porosity gradient that allows the smaller molecules for detection (fructosyl valylhistidine) to flow through to the detection region while excluding the larger molecular weight biomolecules to flow through to the detection region, where the noted layer is above the layer comprising the cross-linked polymeric matrix (or gel) comprising the detection agent, fructosyl oxidase, agent that prevents interference, and peroxidase enzyme disclosed in the multi-layer assay of Qian et al. and Taniguchi et al. noted above (instant claim 1) because doing so would reduce background signal for a better reflectance signal and test accuracy. Since Depa et al. suggest incorporating a reflective material (titanium oxide) that is materially the same and has the same functional purpose as the recited reflective material and Qian et al. disclose materially the same polymers or polymeric matrices for incorporating into a multiple layer assay may be optimized to have a porosity gradient with larger pores near or at the sample application region and smaller pores at the detection region, it would be obvious that the noted layer comprising a polymeric matrix (or hardened gel) for additional functionality comprising titanium oxide as suggested in Depa et al. and a buffered solution as suggested in Qian et al. above can be optimized to have a porosity that allows the smaller molecules for detection (fructosyl valylhistidine) to flow through to the detection region while excluding the larger molecular weight biomolecules to flow through to the detection region.
Regarding Applicants’ remarks that Depa et al.’s porous membrane does not include at least one buffer and a hardened gel and rather Depa et al. utilize a soft and/or hard membrane, the remarks are not persuasive. Depa et al. is cited with at least Qian et al. and Taniguchi et al. above, which disclose the layer(s) of the multilayer reagent test strips are in polymeric matrix (i.e. gel form (Qian et al.)) and that the reagents can be provided in gel form (Taniguchi et al.).
Regarding Applicants’ remarks that the subject application discusses the advantages of using titanium oxide and a hardened gel to create a sieve small enough to allow Fru-alpha-ValHis to pass through while excluding larger molecular weight proteins, the remarks are not persuasive. MPEP 2145 notes that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In this instance, Depa et al. disclose the advantage of incorporating a titanium oxide into a layer under a porous layer to provide opacity to reduce background signal for a better reflectance signal and test accuracy for the optical measuring apparatus (see above).
In the multilayer assay of Qian et al. and Taniguchi et al. above, the blood sample flows through the protease layer before reaching the fructosyl oxidase bottom layer (see above). Qian et al. disclose that one or more additional layers that provide for additional functionality are also present (at least paragraph 0025).
Qian et al. disclose the matrix material is one that is porous and provides for flow of sample fluid through the material; a number of different porous matrices have been developed and are available; where the matrix may have a porosity gradient, with larger pores near or at the sample application region and smaller pores at the detection region (at least paragraph 0056).
Since Depa et al. suggest incorporating a reflective material (titanium oxide) that is materially the same and has the same functional purpose as the recited reflective material and Qian et al. disclose materially the same polymers or polymeric matrices for incorporating into a multiple layer assay may be optimized to have a porosity gradient with larger pores near or at the sample application region and smaller pores at the detection region, it would be obvious that the noted layer comprising a polymeric matrix (or hardened gel) for additional functionality comprising titanium oxide as suggested in Depa et al. and a buffered solution as suggested in Qian et al. above can be optimized to have a porosity that allows the smaller molecules for detection (fructosyl valylhistidine) to flow through to the detection region while excluding the larger molecular weight biomolecules to flow through to the detection region.
Therefore, Applicants’ recognized advantage of titanium oxide and a gel matrix to create a sieve would flow from following the teachings of the prior art.
See also the reasons noted on at least 8-11 of the August 19, 2025 final office action, p. 7-11 of the October 17, 2024 final office action, p. 6-11 of the April 19, 2024 non-final office action, and p. 6-10 of the October 30, 2023 final office action.
For at least these reasons, the 103 rejection is maintained.
Claims 1-2, 4-5, 8, 21, 22-27, 28-30, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (US 20050255453; previously cited) in view of Taniguchi et al. (US 20070154976; previously cited), Depa et al. (WO 2019152508; previously cited), and Yuan et al. (US 20130078664; previously cited). The teachings of Qian et al. in view of Taniguchi et al. and Depa et al. over instant claims 1-2, 4-5, 8, 21, 28-30, 32-36 are noted above. As noted above, Qian et al. in view of Taniguchi et al. and Depa et al. reasonably disclose an assay comprising a stack of film layers, from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a fructosyl oxidase, an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel) and a titanium oxide; and a third film layer comprising a lysing agent (Triton X-100), a denaturing agent (anionic surfactant), and a protease.
Yuan et al. also disclose assays and/or methods for measuring glycated hemoglobin (at least abstract). Similar to Taniguchi et al., Yuan et al. also discloses a composition comprising a lysing buffer comprising protease (at least p. 11 claims 7-8) and a composition comprising fructosyl amino acid oxidase, peroxidase, and a color forming substance (p. 11 claim 13). Yuan et al. disclose lysing buffers generally contain a detergent, including Triton X-100, Tween 20, SDS, CTAB, TTAB, POEs, and NP-40 (at least paragraph 0048).
Therefore, it would have been obvious to one of ordinary skill to substitute and/or incorporate a detergent selected from Tween 20, SDS, CTAB, TTAB, POEs, and NP-40 as suggested in Yuan et al. for the Triton X-100 (lysing agent) in the layer comprising a lysing agent, a denaturing agent (anionic surfactant), and a protease, in the assay comprising a stack of film layers of Qian et al. and Taniguchi et al. and Depa et al. noted above (instant claims 22-27).
Reply: Applicants’ amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Qian et al., Taniguchi et al. and Depa et al. are the same as noted above.
Claims 1-2, 4-5, 8, 21, 28-30, 31, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (US 20050255453; previously cited) in view of Taniguchi et al. (US 20070154976; previously cited), Depa et al. (WO 2019152508; previously cited), and JP ‘919 (JP5870919B2 translation provided by EPO: 35 pages; previously cited). The teachings of Qian et al. in view of Taniguchi et al. over instant claims 1-2, 4-5, 8, 21, 28-30, 32-36 are noted above. As noted above, Qian et al. in view of Taniguchi et al. and Depa et al. reasonably disclose an assay comprising a stack of film layers, from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a fructosyl oxidase, an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel) and a titanium oxide; and a third film layer comprising a lysing agent (Triton X-100), a denaturing agent (anionic surfactant), and a protease.
JP ‘919 also discloses methods and reagent compositions for measuring glycated hemoglobin (at least p. 1). Similar to Qian et al. and Taniguchi et al. also disclose leuco compounds for the color producing compounds (at least paragraph 0057-0060). In addition to DA-67 disclosed in Qian et al. and Taniguchi et l., JP ‘919 also disclose 2-(3,5-dimethoxy-4-hydroxyphenol)-4,5-bis(4-diethylaminophenyl) imidazole (at least paragraph 0058).
Therefore, it would have been obvious to substitute and/or incorporate a 2-(3,5-dimethoxy-4-hydroxyphenol)-4,5-bis(4-dimethylaminophenyl) imidazole as recited in instant claim 31 for the detection agent (indicator dye) in the layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a fructosyl oxidase, an agent that prevents interference, and a peroxidase enzyme, in the assay comprising a stack of film layers of Qian et al. and Taniguchi et al. and Depa et al. noted above (instant claim 31) because JP ‘919 also disclose a leuco compound 2-(3,5-dimethoxy-4-hydroxyphenol)-4,5-bis(4-diethylaminophenyl) imidazole that is similar to the claimed detection agent.
Reply: Applicants’ amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Qian et al., Taniguchi et al. and Depa et al. are the same as noted above.
Claims 1-2, 3, 4-5, 8, 21, 28-30, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (US 20050255453; previously cited) in view of Taniguchi et al. (US 20070154976; previously cited), Depa et al. (WO 2019152508; previously cited), and Bhairi et al. (2017 Sigma-Aldrich Detergents: A guide to the properties and uses of detergents in biological systems: 20 pages; previously cited). The teachings of Qian et al. in view of Taniguchi et al. and Depa et al. over instant claims 1-2, 4-5, 8, 21, 28-30, 32-36 are noted above. As noted above, Qian et al. in view of Taniguchi et al. and Depa et al. reasonably disclose an assay comprising a stack of film layers, from bottom to top, a first film layer comprising a cross-linked polymeric matrix (or gel) comprising a detection agent, a fructosyl oxidase, an agent that prevents interference, and a peroxidase enzyme; a second film layer comprising a polymeric matrix (or gel) and a titanium oxide; and a third film layer comprising a lysing agent (Triton X-100), a denaturing agent (anionic surfactant), and a protease. Additionally, as noted above, Taniguchi et al. disclose a surfactant, i.e. Triton X-100, can be used in combination with other anionic surfactants (at least paragraph 0040) with whole blood samples, where protease can also be combined with the surfactants used for hemolysis (at least paragraph 0044).
Bhairi et al. disclose known detergents including the detergents and/or surfactants disclosed in Taniguchi et al., including Triton X-100 (p. 5). Bhairi et al. disclose other known anionic detergents include N-lauroylsarcosine (p. 6).
Therefore, it would have been obvious to one of ordinary skill to substitute and/or incorporate an anionic detergent including N-lauroylsarcosine as suggested in Bhairi et al. for the anionic surfactant (denaturing agent) in the layer comprising a lysing agent, a denaturing agent (anionic surfactant), and a protease, in the assay comprising a stack of film layers of Qian et al. and Taniguchi et al. and Depa et al. noted above (instant claim 3).
Reply: Applicants’ amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Qian et al., Taniguchi et al. and Depa et al. are the same as noted above.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656