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 .
Status of the Claims
Claims 1-4 and 7-8 are pending in the application.
Claim 7 is withdrawn.
Claims 1-4 and 8 are the subject of this office action.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9 January 2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites an abbreviation that is not spelled-out in its first use in the claims (i.e. BSA and PVA). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected as indefinite over the recitation of “the nitrite” in lines 4, 11-12, and 14 of the claim. This recitation is indefinite because it is unclear whether the term “the nitrite” refers to “a nitrite solution” as introduced in line 2 of the claim or whether it refers to “the nitrite” impregnated in the test strip, as recited in line 12 of the claim. This distinction is important to the claim interpretation as it determines whether the reagents recited in the last paragraph of the claim need to specifically occur in solution with the nitrite or whether they need to be impregnated on the test strip. Additionally, the distinction between the “nitrite solution” of line 2 and the impregnated “the nitrite” is unclear, as there is no introduction of “a nitrite” (i.e. as distinct from “a nitrite solution”) in the claim, such that there is a lack of antecedent basis for the recitation “the nitrite”. For the purposes of applying prior art in the present office action, “the nitrite” as recited in line 4, bridging lines 11-12, and line 14 is understood to refer to “a nitrite solution” as introduced in line 2 of the claim, while “the nitrite” recited later in line 12 is understood to refer to a distinct nitrite reagent which is impregnated on the test strip and is therefore not in solution. This interpretation is informed by the context provided by the claims and the instant specification (see the Examples section of the instant specification). Clarification is required.
Similarly, claims 2 and 8 are rejected as indefinite over the recitation of “the nitrite”.
Dependent claims 2-4 and 8 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hattori et al (WO 2018/168905; previously cited; citations refer to US English Equivalent US 2021/0325384) in view of Imoarai et al (US 2004/0265800 A1).
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. 103 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); 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 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. See generally MPEP § 717.02.
Regarding claim 1, Hattori teaches an immunochromatographic apparatus and method (Abstract) comprising:
A nitrite solution or an acid solution for suspending a specimen (Abstract: a specimen with mixed with nitrite or acid solution before it is added to the immunochromatographic test strip; Par. 97: a specimen or a sample prepared using the specimen is contacted and mixed with a nitrite solution, and the specimen is suspended in the nitrite solution);
An immunochromatographic test strip for extracting and measuring a sugar chain antigen in a specimen (Abstract) comprising:
A sample pad to which the specimen mixed with the nitrite or acid solution is added (Abstract)
A label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (Abstract);
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 (Abstract);
Wherein the immunochromatographic test strip has a region impregnated with the neutralizing reagent, and further has, upstream of the region impregnated with the neutralizing reagent in case the specimen mixed with the nitrite is used, or a region impregnated with the nitrite in case the specimen mixed with the acid solution is used (Abstract).
Hattori does not specifically teach that the apparatus and reagents used in the method are provided in a kit. Hattori does not explicitly teach the nitrite or acid solution comprising one or more selected from the group consisting of NaOH, NALC, NaCl, PVA, BSA, and NaBr.
Regarding claim 1, Imoarai teaches a kit comprising an immunochromatographic device and a sample pretreatment solution (Abstract). Imoarai teaches that the sample pretreatment solution may comprise NaCl which is useful in reducing false positives and mitigating nonspecific binding (Par. 39, 64)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hattori such that the invention comprises a kit which includes a sample pretreatment solution and an immunochromatograpic test strip, as taught by Imoarai. One of ordinary skill in the art would be motivated to make this modification because a kit is a useful format for the provision of the materials and reagents needed to perform an assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of materials and reagents required for an immunoassay in the form of a kit is standard practice in the art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Hattori in view of Imoarai to further include incorporation of NaCl into the sample pretreatment solution taught by Hattori (i.e. the nitrite solution or acid solution used to suspend a sample, as taught by Hattori). One of ordinary skill in the art would be motivated to make this modification because Imoarai teaches that NaCl in a sample pretreatment solution is effective for reducing nonspecific binding and false positives in an immunochromatographic assay (Par. 64). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Hattori and Imoarai are directed to immunochromatographic assays which comprise the use of a sample pretreatment solution and which comprise the use of antibodies for the detection of a target analyte.
Regarding claim 2, Hattori further teaches the kit wherein the region impregnated with the solid acid reagent or the nitrite is present on the sample pad (Par. 61).
Regarding claim 3, Hattori further teaches the kit wherein the solid acid reagent is selected from the group consisting of malonic acid, maleic acid, citric acid, and tartaric acid (Par. 17: solid acid reagent impregnated on the strip may be selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid).
Regarding claim 4, Hattori further teaches the kit wherein the neutralizing reagent is tris(hydroxylmethyl)aminomethane or NaOH (Par. 17).
Claims 1-4 and 8 are rejected under 35 U.S.C. 103 as being obvious over Hattori et al (WO 2018/168905; previously cited; citations refer to US English Equivalent US 2021/0325384) in view of Thieme et al (US 5,871,905).
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. 103 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); 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 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. See generally MPEP § 717.02.
Regarding claims 1-4 and 8, the teachings of Hattori regarding claims 1-4 are as stated in the rejection above.
Hattori does not specifically teach that the apparatus and reagents used in the method are provided in a kit. Hattori does not explicitly teach the nitrite or acid solution comprising one or more selected from the group consisting of NaOH, NALC, NaCl, PVA, BSA, and NaBr.
Though Hattori does not specifically teach that the immunochromatographic test strip and the nitrite solution or acid solution or contained together in a kit, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hattori such that these elements are provided in a kit. One of ordinary skill in the art would be motivated to make this modification because a kit is a convenient format for providing the materials and reagents needed to perform an assay to the end user. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of the materials and reagents required for an assay in a kit is standard practice in the art.
Regarding PVA, Hattori teaches that PVA may be incorporated into the immunochromatographic device to improve reaction conditions, but does not explicitly teach the nitrite solution or acid solution comprising PVA (Par. 17) (i.e. Hattori indicates that PVA is suitable for use with the reagents used in the disclosed invention).
Regarding claims 1-4 and 8, Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hattori to further include incorporation of BSA (claim 1) or PVA (claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in Hattori. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Hattori and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay and immunochromatographic test strip art.
Claims 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shida et al (US 2008/0194013 A1; IDS entered) in view of Thieme et al (US 5,871,905).
Regarding claims 1 and 8, Shida teaches an immunochromatography detection apparatus, method, and kit (Title, Abstract), wherein at least one functional site has at least one of the following functions (a)-(c) provided between the specimen-supply site and the capture reagent site:
A function of pretreating a specimen;
A function of optimizing reaction conditions wherein the analyte contained in the specimen specifically binds to a labeled reagent containing a ligand that specifically binds to the analyte; and
A function of optimizing the reaction conditions wherein a capture reagent specifically binds to the complex of the analyte and the labeled reagent (Par. 8-11).
Specifically, Shida teaches an immunochromatographic test strip for extracting and measuring a sugar chain antigen in a specimen (Par. 8, 81). In detail, the immunochromatographic test strip comprises:
A sample pad to which a specimen mixed with an acid solution is added (Par. 81);
A label region comprising a labeled antibody against a sugar chain antigen (Par. 81);
A detection region on which an antibody against a sugar chain antigen is immobilized, wherein the antibody-antigen complex to be measured is formed (Fig. 7, capture reagent site 4; Par. 8, 83);
The test strip having a region impregnated with neutralizing reagent upstream of the label region (Par. 81); and
A region (located upstream of the neutralizing reagent impregnated region) which is impregnated with solid acid reagent when the specimen is mixed with nitrite or alternatively impregnated with nitrite when specimen is mixed with acid solution (Fig. 6, Par. 82).
Shida differs from the instant invention in that it does not explicitly teach the nitrite solution or acid solution comprising one or more from the group consisting or: NaOH, NALC, NaCl, PVA, BSA, and NaBr.
Regarding claims 1-3 and 8, Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Shida to further include incorporation of BSA (claim 1) or PVA (claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in Shida. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Shida and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shida et al (US 2008/0194013 A1; IDS entered) in view of Thieme et al (US 5,871,905) as applied to claim 1 above, and further in view of Zak et al (US 2008/0206849 A1; IDS entered).
Regarding claim 4, Shida in view of Thieme teaches immunochromatographic assay devices, methods, and kits for antigen extraction utilizing the manipulation of chemical reagents, as discussed above.
Shida in view of Thieme does not explicitly teach the kit wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or NaOH.
Zak teaches throughout the publication a lateral flow assay device for identifying carbohydrate antigen in a biological sample. Specifically, Zak teaches that “a neutralizing agent is preferred as it allows the pH of the reaction mixture to be optimized which in turn allows for optimization of the assay sensitivity…The neutralizing agent where present is preferably buffered. Many such neutralizing buffers are known in the art, although a preferred one is tris(hydroxymethyl)aminomethane (TRIS)” (Par. 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Shida in view of Thieme wherein a neutralizing reagent is used to neutralize a pH level under acidic conditions for extracting carbohydrate antigens, to include using TRIS to allow the pH of the reaction mixture to be optimized for extracting the carbohydrate antigens as taught by Zak, because Zak teaches that TRIS is known in the art as a neutralizing reagent. One would be motivated to make this modification because Shida is generic regarding the neutralizing reagent used, and one would be motivated to select a proper species of neutralizing reagent for the chosen immunoassay for neutralizing a pH under acidic conditions for extracting a carbohydrate antigen, as taught by Zak. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Shida and Zak are directed to methods comprising the use of neutralizing reagents for extracting analytes of interest, including carbohydrate antigens.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 11 of U.S. Patent No. 12,235,265 in view of Shida et al (US 2008/0194013 A1; IDS entered) and Thieme et al (US 5,871,905).
Regarding instant claims 1 and 8, reference claim 1 teaches method for measuring a sugar chain antigen using an immunochromatographic test piece, the method comprising:
mix specimen with nitrite solution;
allow solid acid reagent to contact mixture in filtration step to extract antigen in specimen;
neutralize solid acid reagent;
add mixture to immunochromatographic test piece which comprises:
a sample pad
a neutralizing reagent-impregnated non-woven fabric
a label region comprising a dry pad
and a detection region comprising an antibody-immobilized membrane.
Allow mixture to flow through test piece, measure sugar chain antigen
The reference application, Patent ‘265, differs from the instant claims in that the patent fails to specifically teach a kit concept and the nitrite or acid solution comprising one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Shida teaches an immunochromatographic test kit which reads on instant claim 1 as described in the 103 rejection above. Shida teaches an immunochromatographic test piece comprising a region impregnated with solid acid reagent which is upstream of a region impregnated with neutralizing reagent which is upstream of a label region which is upstream of a detection region.
Patent ‘265 does not specify the order of parts in the immunochromatographic test strip as in the instant claim. However, it would have been obvious to one of ordinary skill in the art to dispose the solid acid reagent upstream of the neutralizing reagent and the neutralizing reagent upstream of the labeling region. One would be motivated to dispose the reagents in this order to ensure their proper functioning for extraction of the target sugar chain antigen (i.e. the sample mixed with nitrite solution should contact the acid first for extraction of the antigen; the sample solution should then be neutralized before contacting the label region, as neutralizing the acidic pH ensures more optimal conditions for binding of the target antigen to the label in the label region). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the order of reagents in the antigen extraction reaction is implied by the steps of the method of the reference claim and because Shida teaches a similar immunochromatographic test strip comprising reagents disposed in this order.
It would have been obvious to one of ordinary skill in the art to have incorporated the immunochromatographic test strip and the extraction reagents into a user-centric kit, as disclosed by Shida. One would be motivated to make this modification for the purpose of providing a format which ensures that an end user has all materials and reagents needed to run the assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of materials and reagents needed to run an assay in the form of a kit is standard practice in the art.
Shida does not explicitly teach the kit wherein the nitrite or acid solution comprises one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, Patent ‘513 (claim 2) teaches that the solid acid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, Patent ‘513 (claim 6) teaches the solid acid reagent to be utilized is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 4, Patent ‘513 (claim 7) teaches the use of neutralizing reagent tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claims 1-4 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 6-8 of U.S. Patent No. 11,906,513 in view of Shida et al (US 2008/0194013 A1; IDS entered) and Thieme et al (US 5,871,905).
Regarding instant claims 1 and 8, see instant claim analysis as disclosed above (Double Patenting rejection over Patent ‘265).
Patent ‘513 (claim 1) teaches an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen comprising: a single specimen adding port in a sample pad to which a specimen mixed with nitrite or an acid solution is added, wherein the sample pad is a site located most upstream of the immunochromatographic test piece; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; 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. The immunochromatographic test piece has a region impregnated with a neutralizing reagent upstream of the labeling region; a region impregnated with a solid acid reagent for when the specimen is mixed with nitrite, or alternatively a region impregnated with nitrite when the specimen is mixed with acid solution- wherein the solid acid reagent region or nitrite reagent region is present upstream of the neutralizing reagent region. Claim 1 of Patent ‘513 further teaches formation of a single flow channel of a continuous lateral flow, wherein a resin- made sheet is sandwiched between the solid acid reagent region or the nitrite region and the neutralizing reagent region such that the utilized regions come into partial contact with each other, and the resin-made sheet suppresses the movement of a reagent or the movement of a specimen solution between the regions
Patent ‘513 differs from the instant claims in that Patent ‘513 further includes the formation of a single flow channel and a resin-made sheet sandwiched between the solid acid reagent region or the nitrite region and the neutralizing reagent region, such that the utilized regions come into partial contact with each other and the resin-made sheet suppresses movement of a reagent or of a specimen solution between regions. It is noted that additional components do not distinguish over the instantly claimed apparatus. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997). Furthermore, both sets of claims recite the same extraction reagents, solid acid reagents, neutralizing reagents and antibodies against sugar chains of protozoan, fungal, bacterial, or viral origin and are therefore not patentably distinguishable.
Additionally, the reference application, Patent ‘513, differs from the instant claims in that the patent fails to specifically teach a kit concept and the nitrite or acid solution comprising one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Shida teaches an immunochromatographic test kit which reads on instant claim 1 as described in the 103 rejection above.
It would have been obvious to one of ordinary skill in the art to have incorporated the immunochromatographic test strip and the extraction reagents into a user-centric kit, as disclosed by Shida. One would be motivated to make this modification for the purpose of providing a format which ensures that an end user has all materials and reagents needed to run the assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of materials and reagents needed to run an assay in the form of a kit is standard practice in the art.
Shida does not explicitly teach the kit wherein the nitrite or acid solution comprises one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, Patent ‘513 (claim 2) teaches that the solid acid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, Patent ‘513 (claim 6) teaches the solid acid reagent to be utilized is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 4, Patent ‘513 (claim 7) teaches the use of neutralizing reagent tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claims 1-4 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 and 6-8 of U.S. Patent No. 12,013,394 in view of Shida et al (US 2008/0194013 A1; IDS entered) and Thieme et al (US 5,871,905).
Regarding instant claims 1 and 8, see instant claim analysis as disclosed above (Double Patenting rejection over Patent ‘265).
Patent ‘394 (claim 1) teaches an immunochromatographic test piece for extracting and measuring a sugar chain antigen of microorganisms belonging to bacterial genus Streptococcus in a specimen. The immunochromatographic test piece comprises: 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; 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; wherein the immunochromatographic test piece has a region impregnated with a neutralizing reagent upstream of the label region, a region impregnated with a solid acid reagent when the specimen is mixed with nitrite, or alternatively a region impregnated with nitrite when the specimen is mixed with the acid solution- wherein the solid acid reagent region or nitrite reagent region is present upstream of the neutralizing reagent region. Claim 1 of Patent ‘394 further teaches that a material for the region impregnated with the neutralizing reagent is a filter or glass filter having three properties: highly absorbable, highly water-retainable, and being low releasable or continuously releasable; wherein the material for the region Impregnated with the neutralizing agent has a basis weight of 50 to 300 g/m2 and a thickness of 0.21 to 0.8 mm, and which absorbs water in an amount of 30 to 100 µl/cm2 per cm/m2, has a water absorption speed of 1.0 to 2.0 µl/sec, retains water in an amount of 15 to 100 µl/cm2 after a fragment of 1 cm/m2 is allowed to come in a wet state into contact with the detection region and left standing for 5 minutes, and has a liquid spread area of 20 mm2 or smaller after a fragment of 1 cm/m2 is allowed to come in a wet state into contact with a membrane and left standing for 5 minutes; wherein owing to the high water-absorption property and the high water-retainability property of the region impregnated with the neutralizing reagent, the acid solution containing the sugar chain antigen is 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 neutralized test solution is continuously developed to the detection region, so that a non-specific reaction is suppressed.
Patent ‘394 differs from the instant claims in that Patent ‘394 further includes detailed material properties for the region impregnated with the neutralizing reagent to include the disclosed three properties recited as highly absorbable, highly water-retainable, and being low releasable or continuously releasable as well as extensive metrics with regards to material weight, thickness, absorption and absorption speed capabilities. It is noted that additional components do not distinguish over the instantly claimed apparatus. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997). Both sets of claims recite the same extraction reagents, solid acid reagents, neutralizing reagents and antibodies against sugar chains of a bacterial microorganism and are therefore not patentably distinguishable.
Patent ‘394 further differs from the instant claims in that the patent fails to specifically teach a kit concept and the nitrite or acid solution comprising one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Shida teaches an immunochromatographic test kit which reads on instant claim 1 as described in the 103 rejection above.
It would have been obvious to one of ordinary skill in the art to have incorporated the immunochromatographic test strip and the extraction reagents into a user-centric kit, as disclosed by Shida. One would be motivated to make this modification for the purpose of providing a format which ensures that an end user has all materials and reagents needed to run the assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of materials and reagents needed to run an assay in the form of a kit is standard practice in the art.
Shida does not explicitly teach the kit wherein the nitrite or acid solution comprises one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, Patent ‘394 (claim 6) teaches that the solid acid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, Patent ‘394 (claim 7) teaches the solid acid reagent to be utilized is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 4, Patent ‘394 (claim 8) teaches the use of neutralizing reagent tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claims 1-4 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-8 of copending Application No. 17/426,557 in view of Thieme et al (US 5,871,905).
17/426,557 (claim 1) teaches 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 a region impregnated with a solid acid reagent when the specimen mixed with the nitrite, or alternatively a region impregnated with nitrite when the specimen mixed with the acid solution- wherein the solid acid reagent region or nitrite reagent region is present upstream of the neutralizing reagent region; Claim 1 of 17/426,557 further teaches a hydrophilic material comprising rayon and 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 which is used for the region impregnated with the nitrite or the solid acid reagent. 17/426,557 (claim 8) teaches an immunochromatographic test kit comprising an immunochromatographic test strip and a nitrite or acid solution.
17/426,557 differs from the instant claims in that 17/426,557 further includes details of a hydrophilic material used for the region impregnated with the nitrite or solid acid reagent to include thickness and mass per unit metrics. It is noted that additional components do not distinguish over the instantly claimed apparatus. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997). Both sets of claims recite the same extraction reagents, solid acid reagent, neutralizing reagents and antibodies against protozoan, bacterial, fungal, or viral origin and are therefore not patentably distinguishable.
17/426,557 further differs from the instant claims in failing to specifically teach the nitrite or acid solution comprising one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, 17/426,557 (claim 4) teaches that the solid aid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, 17/426,557 (claim 5) teaches the solid acid reagent to be utilized is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 4, 17/426,557 (claim 6) teaches the use of neutralizing reagent tris(hydroxymethyl)aminomethane or sodium hydroxide.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, and 6-10 of copending Application No. 17/426,561 in view of Thieme et al (US 5,871,905).
Regarding instant claims 1 and 8, see instant claim analysis as disclosed above (Double Patenting rejection over Patent ‘265).
17/426,561 (claim 1) is 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 has, upstream of the region impregnated with the neutralizing reagent, a region impregnated with a solid acid reagent when the specimen mixed with nitrite, or alternatively a region impregnated with the nitrite when the specimen mixed with the acid solution. 17/426,561 (claim 10) teaches an immunochromatographic test kit comprising an immunochromatographic test strip and a nitrite or acid solution.
17/426,561 differs from the instant claims in that 17/426,561 further includes details of a non-woven fabric (polyester-polyethylene mixture) which is hydrophobic in material and impregnated with a specific range percentage of a surfactant (polyoxyethylene octyl phenyl ether) in the region impregnated with the nitrite or the solid acid reagent. It is noted that additional components do not distinguish over the instantly claimed apparatus. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997). Both sets of claims recite the same extraction reagents, solid acid reagent, neutralizing reagents and antibodies against protozoan, bacterial, fungal, or viral origin and are therefore not patentably distinguishable.
17/426,561 differs from the instant claims in that it does not teach the nitrite solution or acid solution further comprising one or more selected from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, 17/426,561 (claim 6) teaches that the solid acid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, 17/426,561 (claim 7) teaches the solid acid reagent to be utilized is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 4, 17/426,561 (claim 8) teaches the use of neutralizing reagent tris(hydroxymethyl)aminomethane or sodium hydroxide.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,467,923 B2 in view of Hattori et al (WO 2018/168905; previously cited; citations refer to US English Equivalent US 2021/0325384) and Thieme et al (US 5,871,905).
Regarding instant claims 1 and 8, see instant claim analysis as disclosed above (Double Patenting rejection over Patent ‘265).
Reference claim 1 is drawn to An immunochromatographic device comprising an immunochromatographic test strip for extracting and measuring a sugar chain antigen in a specimen and a cassette for accommodating the test strip, wherein: the immunochromatographic test strip comprises a sample pad to which a specimen mixed with the nitrite or 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, an antibody-sugar chain antigen- labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test strip has a region impregnated with a neutralizing reagent upstream of the label region and further has, upstream of the region impregnated with the neutralizing reagent, a region impregnated with a solid acid reagent when the specimen mixed with the nitrite, or a region impregnated with the nitrite when the specimen mixed with the acid solution. The cassette is composed of an upper lid portion and a lower portion, the upper lid portion comprises an upper support having a protrusion that supports the upper side of the immunochromatographic test strip, and the lower cassette portion comprises a lower support comprising a protrusion that supports the lower side of the immunochromatographic test strip, the immunochromatographic device comprises a specimen dropping port on top of a sample pad of the immunochromatographic test strip; the upper support, which supports the immunochromatographic test strip, has features (i)-(iii); the lower support, which supports the immunochromatographic test strip, has features (iv)-(vi):
(i) the upper support is provided to form an edge of an opening on the side of the dropping port opposite from the side to which the specimen is added, and is formed of a sloped protrusion;
(it) when the upper support pushes the upper side of the sample pad of the immunochromatographic test strip in a downward direction, the height of the protrusion becomes smaller toward the downstream side of the immunochromatographic test strip, that is, the protrusion has an increasing slope toward the downstream side of the immunochromatographic test strip:
(iii) when the upper support of the upper lid portion pushes the sample pad, the pressure becomes lower in a downward direction:
(iv) the lower support is formed of a sloped protrusion provided in a region corresponding to the specimen dropping port of the lower cassette portion, wherein the region corresponding to the specimen dropping port of the lower cassette portion is a region overlapping with the opening of the specimen dropping port when the lower cassette portion is covered by the upper lid portion;
(v) when the lower support pushes the sample pad of the immunochromatographic test strip, the height of the protrusion becomes smaller toward the downstream side of the immunochromatographic test strip, that is, the protrusion has a decreasing slope toward the downstream side of the immunochromatographic test strip;
(vi) the pressure to push the sample pad becomes lower in a downward direction.
The reference claim differs from the instant claims in that the reference claim further includes details and limitations with regards to the cassette in which the immunoassay test-strip is accommodated (e.g., features i-vi). It is noted that additional components do not distinguish over the instantly claimed apparatus. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997). Both sets of claims recite same immunochromatography test strip as well as use of extraction reagents, solid acid reagent, neutralizing reagent and antibodies against protozoan, bacterial, fungal, or viral origin and are therefore not patentably distinguishable to carry out the assay.
The reference claim further differs from the instant claims in failing to specifically teach a kit and the nitrite or acid solution comprising one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Shida teaches an immunochromatographic test kit which reads on instant claim 1 as described in the 103 rejection above.
It would have been obvious to one of ordinary skill in the art to have incorporated the immunochromatographic test strip and the extraction reagents into a user-centric kit, as disclosed by Shida. One would be motivated to make this modification for the purpose of providing a format which ensures that an end user has all materials and reagents needed to run the assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the provision of materials and reagents needed to run an assay in the form of a kit is standard practice in the art.
Shida does not explicitly teach the kit wherein the nitrite or acid solution comprises one or more from the group consisting of: sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA, and NaBr.
Thieme teaches methods and reagents for pretreatment of immunoassay samples. The invention provides a method of reducing false positives in assays for the detection of an analyte in a fluid sample (Abstract). Thieme teaches that the preferred immunoassay detection method of the invention is a lateral flow immunoassay (Col. 3, Ln. 59-62). Thieme teaches the method comprising preparation of a fluid sample with a pretreatment solution before the sample is applied to the immunochromatographic test strip (Col. 12, Ln. 26-28). Thieme teaches that the pretreatment solution may comprise a diluent which may comprise BSA and/or PVA (Col. 12, last Par.-Col. 13, first Par.: where a diluent is provided, suitable diluents are chosen to be compatible with the analyte and with the target antibodies and/or proteins of the subject assay. Any diluent typically used in immunoassays is suitable. One of skill in the art will appreciate that the diluent can additionally include a protein or other moiety unrelated to the analyte which participates in non-specific binding reactions with the various components of the assay and thereby blocks and prevents non-specific binding. A particularly preferred blocking agent is BSA or PVA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claim to further include incorporation of BSA ( instant claim 1) or PVA (instant claims 1, 8) intro the nitrite solution or acid solution used as a sample pretreatment solution in the reference invention. One of ordinary skill in the art would be motivated to make this modification because Thieme teaches that both BSA and PVA are advantageous to include in a sample pretreatment solution for the purpose of blocking non-specific binding interactions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claim and Thieme are directed to immunochromatographic detection methods comprising the use of antibodies to detect a particular analyte in a fluid sample, and because BSA and PVA are both common blocking agents in the immunoassay art.
Regarding instant claim 2, reference claim 1 teaches that the solid acid reagent or nitrite is present on the sample pad.
Regarding instant claim 3, the reference claims do not teach the kit wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Regarding instant claim 3, Hattori teaches the kit wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (Par. 17).
It would have been obvious to one of ordinary skill in the art to modify the reference claim such that the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid, as taught by Hattori. One of ordinary skill in the art would be motivated to make this modification because the reference claims recite a solid acid reagent, but are vague regarding the particular species of solid acid reagent. As such, one of ordinary skill in the art would be motivated to use a suitable species of solid acid reagent for the application of extracting a sugar chain antigen, and Hattori teaches appropriate species of solid acid reagent. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Hattori and the reference claims are directed to immunochromatographic devices and methods for the detection of sugar chain antigens comprising a solid acid reagent impregnated onto the test strip.
Regarding instant claim 4, the reference claims do not teach the kit wherein the neutralizing agent is TRIS or NaOH.
Regarding instant claim 4, Hattori teaches the kit wherein the neutralizing agent is TRIS or NaOH (Par. 17).
It would have been obvious to one of ordinary skill in the art to modify the reference claim such that the neutralizing agent is TRIS or NaOH, as taught by Hattori. One of ordinary skill in the art would be motivated to make this modification because the reference claims recite a neutralizing reagent, but are vague regarding the particular species of neutralizing reagent. As such, one of ordinary skill in the art would be motivated to use a suitable species of neutralizing reagent for the application of extracting a sugar chain antigen, and Hattori teaches appropriate species of neutralizing reagent. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Hattori and the reference claims are directed to immunochromatographic devices and methods for the detection of sugar chain antigens comprising a neutralizing reagent impregnated onto the test strip.
Response to Arguments
Applicant’s arguments filed 9 January 2026 have been fully considered.
Regarding the 102 rejection over Hattori, Applicant argues that Hattori teaches PVA used to impregnate a pad on the immunochromatographic test piece, which is distinct from the instant claim wherein PVA is included in solution with the nitrite solution or acid solution. This argument is persuasive and the 102 rejections over Hattori are withdrawn.
Regarding the 103 rejections Applicant argues that these rejections are deficient because they do not teach the nitrite or acid solution comprising one or more from the group consisting of NaOH, NALC, NaCl, PVA, BSA, and NaBr. This argument is persuasive in view of the amendment of the claims, and the previous 103 rejections are withdrawn in favor of the new grounds of 103 rejection presented above.
Regarding the double patenting rejections, applicant argues that the previous double patenting rejections do not properly address the amended claims. This argument is persuasive, and the previous double patenting rejections are withdrawn in favor of the new grounds of double patenting rejections presented above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677