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 .
2. Applicants’ amendment and response of 1/8/2026 are acknowledged. Claim 1 has been amended.
Claims Status
Claims 1 and 4-9 are pending in this application. Claims 1 has been amended. Claims 2-3 have been previously canceled. Claim 9 has been withdrawn from further consideration as being drawn to non-elected invention.
Double Patenting Rejections Withdrawn
4. Rejection of claims 1 and 4-8 on the ground of non-statutory double patenting as being unpatentable over claims 1-7 of US 11906513 B2 in view of its specification, is withdrawn. Applicants have amended claim 1.
Double Patenting Rejections Maintained
5. Rejection of claims 1 and 4-8 on the ground of non-statutory double patenting as being unpatentable over claims 1,3, 4, 5 and 12-14 of co-pending Application No. 16/492,431 in view its specification, is maintained. Applicants have not provided terminal disclosure.
Applicants has argued that amendment to claim recite, " As discussed above, claim I is amended to recite, "wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton ... is used for the region impregnated with the nitrite or the solid acid reagent." None of the reference claims recite these features.
It is this examiner’s position that Application No. 16/492,431 teach limitations of amended claim 1 such, hydrophilic material, glass fiber, filter paper (see claims 4 and 6, pages 3, para 0031, 0075, 0085).
6. Rejection of claims 1 and 4-8 on the ground of non-statutory double patenting as being unpatentable over claims 1, 3-8 and 11 of co-pending Application No. 16/492,442, is maintained. Applicants have not provided terminal disclosure.
Applicants has argued that amendment to claim recite, "" As discussed above, claim I is amended to recite, "wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton ... is used for the region impregnated with the nitrite or the solid acid reagent." None of the reference claims recite these features.
It is this examiner’s position that Application No. 16/492,442, now US 12013394 teach limitations of amended claim1 such as hydrophilic filter (see claim1 of US 12013394).
7. Rejection of claims 1 and 4-8 on the ground of non-statutory double patenting as being unpatentable over claims 1, 2, 6, 7, 9 of co-pending Application No. 17/426,561, is maintained. Applicants have not provided terminal disclosure.
Applicants has argued that amendment to claim recite, "" As discussed above, claim I is amended to recite, "wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton ... is used for the region impregnated with the nitrite or the solid acid reagent." None of the reference claims recite these features.
It is this examiner’s position that Application No. 17/426,561 teach limitations of amended claim 1 such as, glass fiber, filter paper (see claim 5, para 0036, 0037, 0051).
8. Rejection of claims 1 and 4-8 on the ground of non-statutory double patenting as being unpatentable over claims 1-7 of co-pending Application No. 17/426,563, is maintained. Applicants have not provided terminal disclosure.
Applicants has argued that amendment to claim recite, "" As discussed above, claim I is amended to recite, "wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton ... is used for the region impregnated with the nitrite or the solid acid reagent." None of the reference claims recite these features.
It is this examiner’s position that Application No. 17/426,563 teach limitations of amended claim 1 such as glass fiber, filter paper (see page 3, para 0027, 0028, 0031, 0032, 0044, 0076).
Claim Rejections - 35 USC § 102 Maintained
9. Rejection of claims 1 and 4-7 under 35 U.S.C. 102 (a)(2) as being anticipated by JP 2018-151330 A published 9/27/2018 and/or WO2018168905 (published Sept, 2018; priority to March 2018) is maintained.
The amended claims are drawn to an immunochromatographic test strip for extracting and measuring a sugar chain antigen in a specimen, comprising:
a sample pad to which the specimen mixed with a nitrite or an acid solution is added;
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which an antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and wherein the immunochromatographic test strip has a region impregnated with a neutralizing reagent upstream of the label region, and further having, upstream of the region impregnated with the neutralizing reagent, a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with the nitrite when the specimen mixed with the acid solution is used, wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton, having a mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm,. is used for the region impregnated with the nitrite or the solid acid reagent.
Regarding claim 1, JP 2018-151330 A discloses an immunochromatographic test piece for extracting and measuring sugar chain antigens in an analyte, and a method for measuring sugar chain antigens in an analyte using the test piece, the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution, a marker region that includes a marker antibody marking an antibody for sugar chain antigens, and a detection region in which the antibody for sugar chain antigens is immobilized, wherein an antibody-sugar chain antigen- marker antibody complex is formed in the detection region and the sugar chain antigens are measured thereby; the immunochromatographic test piece has a region impregnated with a neutralizing reagent upstream from the marker region; and when an analyte mixed with a nitrite is used, the immunochromatographic test piece further has a region impregnated with a solid acidic reagent upstream from the region impregnated with the neutralizing reagent, or when an analyte mixed with an acidic solution is used, the immunochromatographic test piece further has a region impregnated with a nitrite (see the entire text and all drawings, especially, the claims, paragraphs [0016], [0069],[0070], and [0074]-[0076], etc.).
As to amended limitations, discloses that the material of the porous material used in the region to be impregnated with the neutralizing reagent is a woven fabric having a basis weight of 10 to 400 g / m 2 and a thickness of 0.1 to 2.0 mm, and has a water absorption per 1 cm / m 2. 10 to 100 / in cm 2, and the water absorption speed is 1.0~5.0μl / sec, water retention capacity of 5 minutes after standing in contact with the membrane in a state of still wet pieces of 1 cm / m 2 is 10 to 100 / 2 cm, preferably 1 cm / m 2 in contact with the membrane in a wet state, the liquid spreading area after standing for 5 minutes is 20 mm 2 or less, that is, it has high water absorption and water retention (liquid retention ) And a porous material having three characteristics of low or long-term liquid release. Specific examples include filter paper made of cellulose cotton fiber and glass filter paper made of glass fiber. By using such a porous material, impregnation with an amount of a neutralizing reagent capable of sufficiently neutralizing a specimen from which a sugar chain antigen has been extracted with nitrous acid generated by the reaction between nitrite and an acidic reagent (see description).
As to claims 4-5, JP 2018-151330 A further indicates that a region impregnated with a solid acidic reagent or nitrite is provided on the sample pad constituting the test piece, and the solid acidic reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
As to claims 6 and 7 JP 2018-151330 A further indicates that the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide, and the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus.
In addition, as to limitations of claim 3 JP 2018-151330 A indicates that the pad impregnated with the solid acidic reagent or nitrite or with the neutralizing reagent on the immunochromatographic test piece is formed from a highly hydrophilic material, and thick filter paper is used as the highly hydrophilic material. JP 2018-151330 A also indicates limitations of claims 2 and 3 that the material used for constituting the region to be impregnated with the neutralizing reagent is fabric having a basis weight of 10-400 g/m2 and a thickness of 0.1-2.0 mm and, in particular, is formed from filter paper made of cellulose cotton fibers, glass filter paper made of glass fibers, or the like.
The reference anticipates the claimed invention.
Applicants’ Arguments and Office Response
10. Applicant's arguments filed 1/8/2026 have been fully considered but they are not persuasive. Applicants argue:
Without acquiescing to the merits of the rejections, and solely to expedite allowance, Applicant amended claim 1 to recite, in relevant part, "wherein a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton, having a mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm, is used for the region impregnated with the nitrite or the solid acid reagent." The cited references do not teach or suggest this feature of amended claim 1.
Thus, JP '330 does not disclose that a hydrophilic material is used for the region impregnated with the nitrite or the solid acid reagent, as reflected in the amended claims. Instead, it discloses that a hydrophobic material is used for the region impregnated with the neutralizing agent. Accordingly, JP '330 does not teach or suggest that a hydrophilic material comprising a glass filter paper comprising glass fiber or a filter paper comprising cotton, having a mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm, is used for the region impregnated with the nitrite or the solid acid reagent," as recited in amended claim 1. To further underscore this distinction, rayon and nylon were removed from the claim.
Further, the working examples of JP '330 disclose that filter paper (TOYO ROSHI; No. 26-3) is used for the region impregnated with the neutralizing reagent, and a non-woven fabric (UNITIKA; Elves) is used for the region impregnated with the nitrite or solid acid reagent.
However, "non-woven fabric" is removed from the claims. JP '330 does not teach or suggest any of the recited materials for the region impregnated with the nitrite or the solid acid reagent.
In response to applicants’ arguments, it is the examiner’s position that the reference teaches the added limitations of clam 1 such as rayon, cotton, glass fiber, filter paper.
As to applicants’ arguments that JP 2018-151330 A discloses that the material of the porous material used in the region to be impregnated with the neutralizing reagent is a woven fabric having a basis weight of 10 to 400 g / m 2 and a thickness of 0.1 to 2.0 mm, and has a water absorption per 1 cm / m 2. 10 to 100 / in cm 2. ( see description of invention). It is the examiner’s position that the water absorption speed is 1.0~5.0μl / sec, water retention capacity of 5 minutes after standing in contact with the membrane in a state of still wet pieces of 1 cm / m 2 is 10 to 100 / 2 cm, preferably 1 cm / m 2 in contact with the membrane in a wet state, the liquid spreading area after standing for 5 minutes is 20 mm 2 or less, that is, it has high water absorption and water retention (liquid retention ) And a porous material having three characteristics of low or long-term liquid release. Specific examples include filter paper made of cellulose cotton fiber and glass filter paper made of glass fiber. ( see description). By using such a porous material, impregnation with an amount of a neutralizing reagent capable of sufficiently neutralizing a specimen from which a sugar chain antigen has been extracted with nitrous acid generated by the reaction between nitrite and an acidic reagent (see description). Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102 Maintained
11. Rejection of claims 1 and 4-7 under 35 U.S.C. 102 (a) (2) as being anticipated by Kato et al. (US 20200049703A1 filed 9/9/2019 priority to 3/14/2017), is maintained.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The limitations of the claims are recited above.
As to limitations of claims 1-4, Kato et al. teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a sample pad to which a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a material for the region impregnated with the neutralizing reagent is a filter or a glass filter having three properties of being highly absorbable, being highly water-retainable, and being low releasable or continuously releasable, and owing to the high water-absorbable property and the high water-retainable property of the region impregnated with the neutralizing reagent, the acid solution containing the sugar chain antigen is sufficiently neutralized, and owing to the low releasable property or the sustained releasable property of the region impregnated with the neutralizing reagent, a remaining acid solution is prevented from arriving at the detection region, or a sufficiently neutralized test solution is continuously developed to the detection region, so that a non-specific reaction is suppressed ( see claims 1 and 2 ). Kato et al. further teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a sample pad to which -a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and as to added limitations, the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a material for the region impregnated with the neutralizing reagent is a woven fabric having a basis weight of 10 to 400 g/m2 and a thickness of 0.1 to 2.0 mm ( see claims 1-2 and page 12). The immunochromatographic device according to the above [1] or [2], wherein the pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece is made of a highly hydrophobic material, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is pro- moted by slowing a development time of the specimen sample solution.
The immunochromatographic device according to the above [3], wherein the highly hydrophobic material is selected from the group consisting of polyethylene, polyester, polystyrene, polypropylene, rayon, and nylon.
The immunochromatographic device according to the above [1] or [2], wherein the pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece is made of a material having a high degree of hydrophilicity, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is promoted by slowing a development time of the specimen sample. Regarding claim 5, Kato et al. teach wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (see claim 7), Regarding claim 6, Kato et al. teach wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide (se claim 8). Regarding claim 7 Kato et al, teach that the sugar chain antigen is the sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see original claim 8).
The reference anticipates the claimed invention.
Applicants’ Arguments and Office Response
12. Applicant's arguments filed 1/8/2026 have been fully considered but they are not persuasive. Applicants argue:
Applicant respectfully points out that this description is for the material used for the region impregnated with the neutralizing reagent (not with the nitrite or the solid acid reagent, as reflected in the claims).
Kato also discloses that a non-woven fabric (UNITIKA; Elves) is used for the region impregnated with the nitrite or the solid acid reagent. However, "non-woven fabric" is not recited in the amended claims. Kato does not teach or suggest any of the recited materials for the region impregnated with the nitrite or the solid acid reagent.
Kato does not disclose the use of hydrophilic materials as materials to be impregnated with solid acidic reagent or nitrite, nor does it specifically disclose the use of "a glass filter paper made of glass fiber or a filter paper made of cotton" for the region impregnated with the nitrite or the solid acid reagent. Accordingly, Kato does not anticipate the subject matter of amended claim 1, and Applicant respectfully requests withdrawal of the rejection.
In response to applicants’ arguments, Kato et al. teach glass filter and filter paper (see para, cotton, hydrophilic material (see claim 1, columns 3, 6, 9, 15,19, 21, 22).
Contrary to Applicants arguments, Kato et al. further teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a sample pad to which -a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and as to added limitations, the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a material for the region impregnated with the neutralizing reagent is a woven fabric having a basis weight of 10 to 400 g/m2 and a thickness of 0.1 to 2.0 mm ( see claims 1-2 and page 12). The immunochromatographic device, wherein the pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is pro- moted by slowing a development time of the specimen sample solution.
The immunochromatographic device, wherein the pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece is made of a material having a high degree of hydrophilicity, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is promoted by slowing a development time of the specimen sample solution. ( see para 0096, page 13).
The references teach the amended claims.
Conclusion
13. No claims are allowed.
14. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thurs-Fri 12pm-8pm.
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/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
February 28, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645