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 .
The finality of the rejection of the last Office action is withdrawn.
The reply filed 6/9/26 is entered. Claims 1 and 4-9 are pending. Claim 9 is withdrawn. Claims 1 and 4-8 are under examination.
Claim Rejections Withdrawn
The 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1 and 4-7 under 35 U.S.C. 102 (a)(2) as being anticipated by JP 2018-151330 A published 9/27/2018 cited previously is withdrawn.
The rejection claim(s) 1 and 4-7 under 35 U.S.C. 102(a2) as anticipated by Kato. US 20200049703 2/13/2020 filed 3-14-2018 cited previously is withdrawn.
The 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double patenting as being unpatentable over claims 1,3, 4, 5 and 12-14 of co-pending Application No. 16/492,431 is withdrawn in view of the notice of abandonment mailed 3/5/2026 in the 16/492,431 application.
The 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double patenting as being unpatentable over claims 1, 3-8 and 11 of co-pending Application No. 16/492,442, is withdrawn upon further consideration.
The 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double patenting as being unpatentable over claims 1, 2, 6, 7, 9 of co-pending Application No. 17/426,561 is withdrawn upon further consideration.
The 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of non-statutory double patenting as being unpatentable over claims 1-7 of co-pending Application No. 17/426,563, is withdrawn upon further consideration.
New Claim Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 4-8 is/are rejected under 35 U.S.C. 102(a2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kato. US 20200049703 2/13/2020 filed 3-14-2018.
Claim 1: Kato discloses an immunochromatographic test strip (paragraph 14) for extracting and measuring sugar chain antigens in an analyte, comprising:
the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution is added (paragraph 15),
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (paragraph 15); and
a detection region on which the antibody against the sugar chain antigen is immobilized (paragraph 15),
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen (paragraph 15), and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region (paragraph 15), 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 nitrite when the specimen mixed with the acid solution is used,
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47),
is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Claims 4: Kato discloses a region impregnated with a solid acidic reagent or nitrite is present on the sample pad (paragraph 42).
Claim 5: Kato discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (paragraph 55).
Claim 6: Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide (paragraph 62).
Claim 7: Kato discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see paragraph 72).
Claim 8: Kato discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution (see abstract, paragraph 67, paragraph 81-82, 97-98).
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Response To Applicant’s Argument
Applicants argues that Kato focuses on preventing non-specific reactions by efficiently and continuously neutralizing the developing contain nitrous acid via the material and physical properties of the region impregnated with the neutralizing reagent, which properties include water absorption, water retention, releasbility, a basis weight of 10 to 400 g/m2 and a thickness of 0.1 to 2.0 mm and Kato does not disclose any specific embodiments having all the features of the claimed subject matter as a whole including a region impregnated with the nitrite or the solid acid reagent, having the recited materials (glass filter comprising glass fiber or filter paper comprising cotton) together with the recited mass per unit area and thickness.
Applicants argument has been carefully considered and is not found persuasive.
Kato as stated in the abstract is directed to n 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. See rejection above addressing each claim.
Kato et al disclose hydrophilic (absorbs water) porous material comprising a filter made of cellulose cotton fiber (filter paper comprising cotton), or a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47), is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Kato et al disclose the basis weight of the porous material is 30 g/m2 or 50 g/m2 which falls within the range of 30 g/m2 or 131 g/m2 and the thickness is 0.4 mm or 0.4 to 0.8 mm or 0.6 mm which falls in the range of 0.2 mm to 1.0mm, thus claim 1 as set forth above in the rejection is anticipated. See MPEP 2131.03 (I) A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHING A CLAIMED RANGE ANTICIPATES THE RANGE.
In the alternative, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm. This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Claim(s) 1 and 4-8 is/are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over JP 2018151330 published 09-27-2018.
Claim 1: JP 2018151330 discloses an immunochromatographic test strip (see under description of embodiments “the immunochromatographic test strip of the present invention” and figure 1 and figure 2) for extracting and measuring sugar chain antigens in an analyte (see abstract and under technical field), comprising:
a sample pad added with a specimen mixed with a nitrite acid or an acid solution: That is, the present invention includes the following inventions… [2] A sample pad to which a sample mixed with nitrite or an acidic solution is added;
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen: That is, the present invention includes the following inventions… [2] sample pad to which a sample mixed with nitrite or an acidic solution is added, a sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen; and
a detection region on which the antibody against the sugar chain antigen is immobilized: That is, the present invention includes the following inventions… [2] a sample pad to which a sample mixed with nitrite or an acidic solution is added, a sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar antigen is immobilized;
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen: That is, the present invention includes the following inventions… [2] a sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar chain antigen is immobilized, An immunochromatographic test piece for measuring a sugar chain antigen by forming an antibody-sugar chain antigen-labeled antibody complex in a detection region; and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region: That is, the present invention includes the following inventions… [2] A sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar chain antigen is immobilized, An immunochromatographic test piece for measuring a sugar chain antigen by forming an antibody-sugar chain antigen-labeled antibody complex in a detection region, and having a region impregnated with a neutralizing reagent upstream of the labeled body 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 nitrite when the specimen mixed with the acid solution is used: That is, the present invention includes the following inventions… [2] A sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar chain antigen is immobilized, An immunochromatographic test piece for measuring a sugar chain antigen by forming an antibody-sugar chain antigen-labeled antibody complex in a detection region, and having a region impregnated with a neutralizing reagent upstream of the labeled body region, Further, when using a specimen mixed with nitrite upstream of the area impregnated with the neutralizing reagent, it has an area impregnated with a solid acidic reagent, and impregnating nitrite when using a specimen mixed with an acidic solution;
having a region impregnated with a neutralization reagent in the upstream of the labelling region and further having the region impregnated with the solid acid reagent when using the specimen mixed with the nitrite in the upstream of the region impregnated with the neutralization reagent, and having the region impregnated with the nitrite when using the specimen mixed with the acid solution; and
That is, it has a region impregnated with a neutralizing reagent upstream of the labeled region, and further has a region impregnated with a solid acidic reagent or nitrite upstream of the region impregnated with the neutralizing reagent;
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.6 mm is used for the region impregnated with the nitrite or the solid acid reagent discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material:
Further, it is not always necessary to impregnate the solid acidic reagent region or nitrite region, neutralizing reagent region, and labeling region in separate porous materials, and plural or all regions may be impregnated in the same porous material,
That is, a solid acidic reagent region and a neutralizing reagent region exist on the sample pad. In this test piece, the solid acidic reagent region and the neutralizing reagent region are provided in the form of a single porous material (pad),
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 .sup.2 and a thickness of 0.1 to 2.0 mm, and has a water absorption per 1 cm / m .sup.2. 10 to 100 / in cm .sup.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 .sup.2 is 10 to 100 / .sup.2 cm, preferably 1 cm / m .sup.2 in contact with the membrane in a wet state, the liquid spreading area after standing for 5 minutes is 20 mm .sup.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. Examples of such filter paper include No. 26-3 of Toyo Filter Paper Co., Ltd. Moreover, the volume of the filter paper to be used is large, and an acidic solution that arrives later than the sample from the upstream can be sufficiently retained. 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. Can do. In addition, since the pad can absorb and retain a large amount of liquid and the release performance lasts, sufficient neutralization ability even when a liquid containing nitrous acid remaining upstream of the immunochromatographic test piece develops after the determination time As a result, it is possible to suppress the acidic solution from reaching the detection region where the antibody is immobilized, thereby suppressing the non-specific reaction and detecting the sugar chain antigen without causing the non-specific reaction. it can. On the other hand, in the case of glass filter paper with high water absorption, high water retention, and low release, specific examples include GS-25 from Toyo Filter Paper Co., Ltd. Since the reagent can be impregnated, water retention is high, and water release is low, the acidic solution is prevented from reaching the solidified detection region. As a result, non-specific reactions can be suppressed when negative, and line color development after the determination time can be prevented when positive.
The “weight per unit area” of the porous material used in the region impregnated with the neutralizing reagent is 10 to 400 g / m .sup.2 . Here, “weight per unit” refers to the weight per unit area (1 m .sup.2 ) of cloth or the like. The basis weight can be appropriately changed depending on the amount and composition of the neutralizing reagent impregnated in the pad. When the basis weight is 30 g / m .sup.2 or less, the porosity is high, and when impregnated with a neutralizing reagent, it becomes easy to tear off, and handling during immunochromatography is difficult, so the basis weight is preferably 50 g / m .sup.2 or more. In the case of 300 g / m .sup.2 or more, the porosity is low and it depends on the composition of the neutralizing reagent, but the sample does not penetrate the material smoothly and cannot be mixed with the neutralizing reagent, so it is 300 g / m .sup.2 or less. It is preferable. The most preferred basis weight is 250 to 270 g / m .sup.2 .
Further, the “thickness” of the porous material used in the region impregnated with the neutralizing reagent is preferably 0.1 to 2.0 mm, but the thickness can be appropriately changed depending on the amount and composition of the neutralizing reagent impregnated into the pad. . When the thickness is 0.4 mm or less, it becomes easy to tear when impregnated with a neutralizing reagent, and handling at the time of immunochromatography production becomes difficult. In view of easy adjustment and ease of handling during immunochromatography production, about 0.6 mm is more preferable.
Claims 4: JP 2018151330 discloses the region impregnated with a solid acidic reagent or nitrite is present on the sample pad: In order to impregnate the sample pad or the porous material with the solid acidic reagent or nitrite, the solid acidic reagent or nitrite is once dissolved, applied, and dried.
Claim 5: JP 2018151330 discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid: Preferred solid acidic reagents used in the present invention include malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Claim 6: JP 2018151330 Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide: Preferred neutralizing reagents used in the present invention include tris base (trishydroxylmethylaminomethane), sodium hydroxide, dipotassium hydrogen phosphate, trisodium citrate.
Claim 7: JP 2018151330 discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus: …wherein the sugar chain antigen is a sugar chain antigen of a protozoan, fungus, bacteria, mycoplasma, rickettsia, chlamydia, or virus.
Claim 8: JP 2018151330 discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution: A method for using the device of the present invention will be described based on the immunochromatographic device in which the immunochromatographic test piece having the form of FIG. The following method of use is a method in which a sample is mixed with a nitrite solution and measured using an immunochromatography method impregnated with a solid acidic reagent and a neutralizing reagent. When the immunochromatographic device has a region impregnated with a solid acidic reagent, the sample is mixed with a nitrous acid solution. When the immunochromatographic device has a region impregnated with a nitrite, the sample is mixed with an acidic solution, and the sample of the immunochromatographic device is mixed.
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
JP 2018151330 discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.6 mm.
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.6 mm.
This is because JP 2018151330 discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Response to Applicants’ Argument (JP’ 330):
Applicants state that claim 1 recites that 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 is used, or a region impregnated with the nitrite when the specimen mixed with the acid solution is used and claim 1 also recites 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 and thus, the recited features correspond to the region impregnated with the nitrite or the solid acid reagent which is upstream of the region impregnated with the neutralizing reagent and that the recited features do not correspond to the region impregnated with the neutralizing reagent, as disclosed in JP '330 and that JP '330 does not disclose the recited region impregnated with the nitrite or the solid acid reagent, having the recited mass per unit area and thickness.
Applicants argument has been considered but is not found persuasive. As stated in the rejection above JP '330 discloses the limitation recited in the claim “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” as follows
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region: That is, the present invention includes the following inventions… [2] A sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar chain antigen is immobilized, An immunochromatographic test piece for measuring a sugar chain antigen by forming an antibody-sugar chain antigen-labeled antibody complex in a detection region, and having a region impregnated with a neutralizing reagent upstream of the labeled body 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 nitrite when the specimen mixed with the acid solution is used: That is, the present invention includes the following inventions… [2] A sample pad to which a sample mixed with nitrite or an acidic solution is added, a labeled body region containing a labeled antibody labeled with an antibody against a sugar chain antigen, and a detection region on which the antibody against the sugar chain antigen is immobilized, An immunochromatographic test piece for measuring a sugar chain antigen by forming an antibody-sugar chain antigen-labeled antibody complex in a detection region, and having a region impregnated with a neutralizing reagent upstream of the labeled body region,
Further, when using a specimen mixed with nitrite upstream of the area impregnated with the neutralizing reagent, it has an area impregnated with a solid acidic reagent, and impregnating nitrite when using a specimen mixed with an acidic solution;
having a region impregnated with a neutralization reagent in the upstream of the labelling region and further having the region impregnated with the solid acid reagent when using the specimen mixed with the nitrite in the upstream of the region impregnated with the neutralization reagent, and having the region impregnated with the nitrite when using the specimen mixed with the acid solution; and
That is, it has a region impregnated with a neutralizing reagent upstream of the labeled region, and further has a region impregnated with a solid acidic reagent or nitrite upstream of the region impregnated with the neutralizing reagent.
Applicants argument that claim 1 also recites 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 and thus, the recited features correspond to the region impregnated with the nitrite or the solid acid reagent which is upstream of the region impregnated with the neutralizing reagent is not persuasive.
JP '330 discloses that the hydrophilic material is used for the region impregnated with the nitrite or solid acid reagent by or all the regions including the neutralizing region on a single porous material: the porous material is used for the region impregnated with the (1) nitrite or (2) the solid acid reagent or (3) all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material (single pad test piece) or a two pad test when the solid acidic reagent region and the neutralizing reagent region are provided in the form of two separate porous materials (pads), they may be referred to as a two-pad test piece.
In figure 1 and 2, a region impregnated with the solid acidic reagent is referred to as a solid acidic reagent region 5, and a region impregnated with the neutralizing reagent is referred to as a neutralizing reagent region 6 and the label region is 2.
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As you can see in the test strip of figures 1 and 2, the region impregnated with neutralizing agent (region 6) is always upstream of label region 2 and the region impregnated with a solid acid reagent (region 5) is located upstream of the region impregnated with neutralizing reagent (region 6).
In figure 1, the region impregnated with neutralizing reagent region 6 and the region impregnated with a solid acid reagent (region 5) is on a single porous material.
Further, the reference discloses it is not always necessary to impregnate the solid acidic reagent region or nitrite region, neutralizing reagent region, and labeling region in separate porous materials, and plural or all regions may be impregnated in the same porous material. Thus, it follows that the porous material used for the neutralizing reagent region is also used for the nitrite region or solid acid reagent region.
JP’330 discloses 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 .sup.2 and a thickness of 0.1 to 2.0 mm, and has a water absorption and disclose 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.
JP’330 discloses: The “weight per unit area” of the porous material used in the region impregnated with the neutralizing reagent is 10 to 400 g / m2 . Here, “weight per unit” refers to the weight per unit area (1 m .sup.2 ) of cloth or the like. The basis weight can be appropriately changed depending on the amount and composition of the neutralizing reagent impregnated in the pad. When the basis weight is 30 g / m2 or less, the porosity is high, and when impregnated with a neutralizing reagent, it becomes easy to tear off, and handling during immunochromatography is difficult, so the basis weight is preferably 50 g / m2 or more.
Thus, the disclosure of 30 g/m2 or 50 g/m2 anticipates the range of 30 g/m2 to 131 g/m2.
JP’330 discloses: the “thickness” of the porous material used in the region impregnated with the neutralizing reagent is preferably 0.1 to 2.0 mm, but the thickness can be appropriately changed depending on the amount and composition of the neutralizing reagent impregnated into the pad. When the thickness is 0.4 mm or less, it becomes easy to tear when impregnated with a neutralizing reagent, and handling at the time of immunochromatography production becomes difficult. In view of easy adjustment and ease of handling during immunochromatography production, about 0.6 mm is more preferable.
Thus, the disclosure of thickness of 0.4 mm or about 0.6 mm anticipates 0.2mm to 1mm recited in the claim.
In the alternative, regarding the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM, these would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.6 mm. This is because JP 2018151330 discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Thus, from all the teachings of JP’330 one of ordinary skill in the art would have readily envisaged the recited region impregnated with the nitrite or the solid acid reagent having the recited mass per unit area and thickness, based on the disclosure of JP’330.
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 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12013394 in view of Kato. US 20200049703 2/13/2020 filed 3-14-2018.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘394 claims disclose:
Claim 1 and claim 7: An immunochromatographic test piece for extracting and measuring a sugar chain antigen of microorganisms belonging to genus Streptococcus in a specimen, 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 wherein
the immunochromatographic test piece has a region impregnated with a neutralizing reagent upstream of the label region, and
further 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 nitrite when the specimen mixed with the acid solution is used,
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 (hydrophilic), 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 and wherein the material for the region impregnated with the neutralizing reagent has a thickness of 0.4 mm to 0.8 mm.
Claim 4: The immunochromatographic test piece according to claim 1, wherein the region impregnated with the solid acid reagent or the nitrite is present on the sample pad.
Claim 5: The immunochromatographic test piece according to claim 1, wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Claim 6: The immunochromatographic test piece according to claim 1, wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claim 8: The ‘394 claims disclose an immunochromatographic test kit for extracting and measuring a sugar chain antigen of microorganisms belonging to genus Streptococcus in a specimen, comprising the immunochromatographic test piece and a nitrite or an acid solution as set forth above.
The ‘394 claims do not disclose the test piece is a test strip and does not disclose 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 area impregnated with solid acid reagent or impregnated with nitrite.
Claim 1: Kato discloses an immunochromatographic test strip (paragraph 14) for extracting and measuring sugar chain antigens in an analyte, comprising:
the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution is added (paragraph 15),
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (paragraph 15); and
a detection region on which the antibody against the sugar chain antigen is immobilized (paragraph 15),
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen (paragraph 15), and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region (paragraph 15), 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 nitrite when the specimen mixed with the acid solution is used,
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47),
is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Claims 4: Kato discloses a region impregnated with a solid acidic reagent or nitrite is present on the sample pad (paragraph 42).
Claim 5: Kato discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (paragraph 55).
Claim 6: Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide (paragraph 62).
Claim 7: Kato discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see paragraph 72).
Claim 8: Kato discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution (see abstract, paragraph 67, paragraph 81-82, 97-98).
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the test piece of ‘394 claims by using a test strip as the test piece and also have used 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 or 50 g/m2 and a thickness of 0.4 mm or 0.4 to 0.8 mm or 0.6 mm for the area impregnated with solid acid reagent or impregnated with nitrite, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that the test piece of Kato et al is a test strip format comprising a region impregnated with neutralizing agent as well as a region impregnated with nitrite reagent or a solid acid reagent and Kato discloses that the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material and that the porous material can be a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm and that the test strip is suitable for extracting and measuring sugar chain of bacteria.
Regarding the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area range of 30 g/m2 to 131 g/m2 and a thickness range of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Claims 1 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 6-11 of copending Application No. 17426561 (‘561) in view of Kato. US 20200049703 2/13/2020 filed 3-14-2018.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: 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 the nitrite is used, or a region impregnated with the nitrite when the specimen mixed with the acid solution is used, and wherein a non-woven fabric comprising a polyester-polyethylene mixture which is a hydrophobic material impregnated with 1.0 to 2.0 (w/v) % of a polyoxyethylene octyl phenyl ether is used for the region impregnated with the nitrite or the solid acid reagent, wherein the polyoxyethylene octyl phenyl ether concentration is optimized for extraction time and signal strength and shortens the time until the development starts.
Claim 4: The immunochromatographic test strip according to claim 1, wherein the region impregnated with the solid acid reagent or the nitrite is present on the sample pad.
Claim 5: The immunochromatographic test strip according to claim 1, wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Claim 6: The immunochromatographic test strip according to claim 1, wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claim 7: The immunochromatographic test strip according to claim 1, wherein the sugar chain antigen is a sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus.
Claim 8: An immunochromatographic test kit, comprising: the immunochromatographic test strip according to claim 1, and a nitrite solution or an acid solution.
The ‘561 claims do not disclose does not disclose 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 area impregnated with solid acid reagent or impregnated with nitrite.
Claim 1: Kato discloses an immunochromatographic test strip (paragraph 14) for extracting and measuring sugar chain antigens in an analyte, comprising:
the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution is added (paragraph 15),
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (paragraph 15); and
a detection region on which the antibody against the sugar chain antigen is immobilized (paragraph 15),
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen (paragraph 15), and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region (paragraph 15), 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 nitrite when the specimen mixed with the acid solution is used,
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47),
is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Claims 4: Kato discloses a region impregnated with a solid acidic reagent or nitrite is present on the sample pad (paragraph 42).
Claim 5: Kato discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (paragraph 55).
Claim 6: Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide (paragraph 62).
Claim 7: Kato discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see paragraph 72).
Claim 8: Kato discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution (see abstract, paragraph 67, paragraph 81-82, 97-98).
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
It would have been prima facie obvious to the person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the test strip of the ‘561 claims as taught by Kato et al such 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 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm is used for the area impregnated with solid acid reagent or impregnated with nitrite.
The motivation to do so is that the test piece of Kato et al is a test strip format comprising a region impregnated with neutralizing agent as well as a region impregnated with nitrite reagent or a solid acid reagent and Kato discloses that the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material and that the porous material can be a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm and that the test strip is suitable for extracting and measuring sugar chain of bacteria.
Regarding the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area range of 30 g/m2 to 131 g/m2 and a thickness range of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-8 of copending Application No. 17/426,563 (‘563) in view of Kato. US 20200049703 2/13/2020 filed 3-14-2018.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘563 claims disclose:
Claim 1: An immunochromatographic test kit comprising:(i) a nitrite solution or an acid solution for suspending a specimen; and(ii) 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 the nitrite solution 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 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 in case the specimen mixed with the nitrite solution is used, or a region impregnated with the nitrite in case the specimen mixed with the acid solution is used,
wherein the nitrite solution or acid solution comprises is sodium hydroxide.
Claim 4: The immunochromatographic test strip according to claim 1, wherein the region impregnated with the solid acid reagent or the nitrite is present on the sample pad.
Claim 5: The immunochromatographic test strip according to claim 1, wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Claim 6: The immunochromatographic test strip according to claim 1, wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claim 8: An immunochromatographic test kit, comprising: the immunochromatographic test strip according to claim 1, and a nitrite solution or an acid solution.
The ‘563 claims does not disclose the sugar chain antigen is a sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus and does not disclose 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 area impregnated with solid acid reagent or impregnated with nitrite.
Claim 1: Kato discloses an immunochromatographic test strip (paragraph 14) for extracting and measuring sugar chain antigens in an analyte, comprising:
the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution is added (paragraph 15),
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (paragraph 15); and
a detection region on which the antibody against the sugar chain antigen is immobilized (paragraph 15),
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen (paragraph 15), and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region (paragraph 15), 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 nitrite when the specimen mixed with the acid solution is used,
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47),
is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Claims 4: Kato discloses a region impregnated with a solid acidic reagent or nitrite is present on the sample pad (paragraph 42).
Claim 5: Kato discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (paragraph 55).
Claim 6: Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide (paragraph 62).
Claim 7: Kato discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see paragraph 72).
Claim 8: Kato discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution (see abstract, paragraph 67, paragraph 81-82, 97-98).
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the ‘563 claims as taught by Kato et al, such 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 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm is used for the area impregnated with solid acid reagent or impregnated with nitrite and that the sugar chain antigen is a sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that the test piece of Kato et al is a test strip format comprising a region impregnated with neutralizing agent as well as a region impregnated with nitrite reagent or a solid acid reagent and Kato discloses that the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material and that the porous material can be a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm and that the test strip is suitable for extracting and measuring a sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus.
Regarding the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area range of 30 g/m2 to 131 g/m2 and a thickness range of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11906513 (‘513) in view of Kato. US 20200049703 2/13/2020 filed 3-14-2018.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘513 claims disclose:
Claim 1: 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 neutralizing reagent region impregnated with a neutralizing reagent, and further having a solid acid reagent region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a nitrite region impregnated with nitrite when the specimen mixed with the acid solution is used, the neutralizing reagent region being present upstream of the label region, and the solid acid reagent region or nitrite region being present upstream of the neutralizing reagent region.
Claim 4: The immunochromatographic test piece according to claim 1, wherein the region impregnated with the solid acid reagent or the nitrite is present on the sample pad.
Claim 5: The immunochromatographic test piece according to claim 1, wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid.
Claim 6: The immunochromatographic test piece according to claim 1, wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide.
Claim 7: The immunochromatographic test piece according to claim 1, wherein the antibody against the sugar chain antigen is an antibody against the sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus.
Claim 8: The ‘513 claims disclose an immunochromatographic test kit for extracting and measuring a sugar chain antigen of microorganisms comprising the immunochromatographic test piece and a nitrite or an acid solution as set forth above.
The ‘513 claims do not disclose the test piece is a test strip and does not disclose 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 area impregnated with solid acid reagent or impregnated with nitrite.
Claim 1: Kato discloses an immunochromatographic test strip (paragraph 14) for extracting and measuring sugar chain antigens in an analyte, comprising:
the immunochromatographic test piece including a sample pad to which is added an analyte that has mixed therein a nitrite or an acidic solution is added (paragraph 15),
a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (paragraph 15); and
a detection region on which the antibody against the sugar chain antigen is immobilized (paragraph 15),
wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen (paragraph 15), and
wherein the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region (paragraph 15), 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 nitrite when the specimen mixed with the acid solution is used,
wherein a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47),
is used for the region impregnated with the nitrite or the solid acid reagent i.e. paragraph 53 discloses that all the regions including the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material.
Claims 4: Kato discloses a region impregnated with a solid acidic reagent or nitrite is present on the sample pad (paragraph 42).
Claim 5: Kato discloses the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid (paragraph 55).
Claim 6: Kato discloses the neutralizing reagent is tris (hydroxymethyl) aminomethane or sodium hydroxide (paragraph 62).
Claim 7: Kato discloses the sugar chain antigens to be extracted and measured are the sugar chain antigens of a protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus (see paragraph 72).
Claim 8: Kato discloses an immunochromatographic test kit above comprising the immunochromatographic test strip as set forth in claim 1-7 and a nitrite solution or acid solution (see abstract, paragraph 67, paragraph 81-82, 97-98).
In the alternative, the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the test piece of ‘513 claims by using a test strip as the test piece and also have used 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 or 50 g/m2 and a thickness of 0.4 mm or 0.4 to 0.8 mm or 0.6 mm for the area impregnated with solid acid reagent or impregnated with nitrite, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that the test piece of Kato et al is a test strip format comprising a region impregnated with neutralizing agent as well as a region impregnated with nitrite reagent or a solid acid reagent and Kato discloses that the nitrite region, the solid acid reagent region and neutralizing reagent region are impregnated into a single porous material and that the porous material can be a hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm and that the test strip is suitable for extracting and measuring sugar chain of bacteria.
Regarding the hydrophilic material comprising a glass filter comprising glass fiber or a filter paper comprising cotton having the mass per unit area range of 30 g/m2 to 131 g/m2 and a thickness range of 0.2 mm to 1.0 mm:
Kato discloses hydrophilic (absorbs water) porous material comprising filter made of cellulose cotton fiber (filter paper comprising cotton), and a glass filter (glass filter paper) made of glass fiber (see paragraph 45) , having a mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 (see paragraph 46) and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm (see paragraph 47).
Therefore, the mass per unit area of 30 g/m2 to 131 g/m2 and a thickness of 0.2 mM to 1.0 mM would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention over the disclosure of mass per unit area of 10-400 g/m2 or 30 g/m2 or 50 g/m2 and a thickness of 0.1 to 2 mm, or 0.4 mm or 0.4 to 0.8 mm or 0.6 mm.
This is because Kato et al discloses that the basis weight can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad and the thickness can be appropriately changed by adjusting the amount or composition of the neutralizing reagent impregnated into the pad.
Status of Claims
Claims 1 and 4-8 are rejected. Claim 9 is withdrawn.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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