DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendment
2. The amendment filed January 14, 2026 was entered. Claim 1 was amended. Claims 2-3 and 5 were cancelled. Claims 1, 4 and 6-11 are under consideration in this Office Action.
Withdrawn Claim Rejections
3. The following rejections are withdrawn in view of Applicants Amendments and Applicants arguments:
The rejection of claims 1, 4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017213228 (published Dec. 14, 2017; priority to JP2016-115626 June 9, 2016) in view of Hiroshi et al., (US Patent 5,506,041 published 1996-04-09) and Kato et al., (US 2016/0370368 published Dec. 22, 2016; priority to Aug 8, 2014); and
The rejection of claims 1, 4 and 6-11 under 35 U.S.C. 103 as being unpatentable over WO 2017213228 in view of Hiroshi et al., and Kato et al.
New Grounds of Rejection Necessitated By Applicants Amendments
Claim Rejections - 35 USC § 112
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.
4. Claim 1 is 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 recites the limitation "the time" and “the development” within the claim. However, neither the time nor any type of development was previously recited by the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required to overcome the rejection.
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.
5. Claims 1, 4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017213228 (published Dec. 14, 2017; priority to JP2016-115626 June 9, 2016) in view of Hattori et al., (WO 2018168907 published 2018-0920; priority to 2017-03-14 JP2017049213) and Hiroshi et al., (US Patent 5,506,041 published 1996-04-09). Documents available on Google Patents.
The claims are drawn to an immunochromatographic test strip for extracting and measuring a sugar chain antigen in a specimen, comprising: a sample pad to which the specimen mixed with a nitrite or an acid solution is added, a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen, and a detection region on which an antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and wherein the immunochromatographic test strip has a region impregnated with a neutralizing reagent upstream of the label region, and further 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, wherein a non-woven fabric comprising a polyester-polyethylene mixture which is a hydrophobic material and 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.
WO2017213228 teach an immunochromatographic test strip, which controls the development of a specimen on the immunochromatographic test strip and appropriately controls a treatment with an acid reagent and a nitrite, and a neutralizing reagent; and an immunochromatography method using the test strip. The immunochromatographic test strip extracts and measures 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, wherein a hydrophobic material is used for the region impregnated with the nitrite or the solid acid reagent [abstract]. The material forming the support is not particularly limited [Present Invention]. The immunochromatographic test strip’s material is commonly a non-woven fabric.
Thus teaching claim 1. Examples of the solid acidic reagent having these characteristics include tartaric acid, malonic acid, malic acid, maleic acid, citric acid and the like. In the present invention, the antigen has all the above characteristics and is equivalent to the liquid acidic reagent. The only solid acidic reagent having extractability is tartaric acid. [Present Invention]. Thus teaching claims 1 and 6-7. Preferred neutralizing reagents used in the present invention include tris (trishydroxylmethylaminomethane), sodium hydroxide, and a good buffer having a buffer capacity in the alkaline region. Thus teaching claims 1 and 8.
The sugar chain antigen is a sugar chain antigen of a protozoan, fungus, bacteria, mycoplasma, rickettsia, chlamydia or virus, and the sugar chain antigen in the specimen is obtained by the immunochromatography method [Present Invention [4]]. Thus teaching claims 1 and 9. WO2017213228 teach an immunochromatographic test piece comprising a sample pad, a label region, a detection region, and an absorption band from the upstream side, and tartaric acid as a solid acidic reagent upstream from the label region. An immunochromatographic test strip impregnated with a neutralizing reagent is provided. Moreover, this invention provides the immunochromatography method performed using the immunochromatography test piece of the said invention. Thus disclosing claim 10. A method for measuring a sugar chain antigen in a sample by an immunochromatography method using an immunochromatographic test piece having a region impregnated with tartaric acid upstream of the region, Mixing the specimen with a nitrite solution and adding it to the sample pad of the immunochromatographic test strip, In the region impregnated with tartaric acid, sugar chain antigens are extracted from the specimen by the action of nitrous acid generated by the reaction of nitrite and tartaric acid, In the region impregnated with the neutralizing reagent, the acidic solution containing the sugar chain antigen is neutralized, In the detection region, an antibody-sugar chain antigen-labeled antibody complex is formed [A method of measuring sugar chain antigens in a specimen by immunochromatography]. For example, the control display area exists downstream of the detection area, and when the specimen sample passes through the detection area and reaches the control display area, a signal is emitted by coloring or the like. In the control display area, a substance that binds to the antibody to which the labeling carrier is bound may be immobilized, or a reagent such as a pH indicator that changes color when the sample arrives is immobilized. Also good. When the antibody to which the labeling carrier is bound is a mouse monoclonal antibody, an anti-mouse IgG antibody may be used. After 5 minutes, the presence or absence and degree of colored polystyrene particles on a predetermined position on which the anti-Streptococcus pyogenes antibody was immobilized were visually determined [Example 1]. Thus teaching claim 11.
Therefore, WO 2017213228 describe 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, wherein a hydrophobic non-woven fabric is used; but does not teach the non-woven fabric is polyester-polyethylene mixture which is a hydrophobic and impregnated with 1.0 to 2.0 (w/v) % of a polyoxyethylene octyl phenyl ether.
Hattori et al., teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a sample pad to which a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a resin-made sheet is sandwiched between the region impregnated with the solid acid reagent or the nitrite and the region impregnated with the neutralizing reagent so as to suppress the movement of a reagent or the movement of a specimen solution between the regions [para 24-25]. For an immunochromatography method, it may be necessary to control a chromatographic development speed on an immunochromatographic test piece, and an immunochromatography method of controlling the development speed on the basis of a device shape, an adhering position, a material to be used, i.e, a material such as a non-woven fabric [para 7]. The sample pad is a site to which a specimen is added, and is a porous material. The sample pad is a site located most upstream of the immunochromatographic test piece. As a material for the sample pad, commonly used non-woven fabric, can be used [para 44].
The pad impregnated with the solid acid reagent or the nitrite is present above the resin-made sheet located above the region impregnated with the neutralizing reagent. The solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid [para 25]. The sugar chain antigen is the sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus [para 25]. The immunochromatographic device comprises a pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece is made of a highly hydrophobic material, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is promoted by slowing a development time of the specimen sample solution.The immunochromatographic device has the pad impregnated with the solid acid reagent or the nitrite, or the neutralizing reagent on the immunochromatographic test piece is made of a highly hydrophobic material, and the extraction of the sugar chain antigen with the nitrite and the solid acid reagent is promoted by slowing a development time of the specimen sample solution. The immunochromatographic device comprises a highly hydrophobic material is selected from the group consisting of polyethylene, and polyester [para 109]. The immunochromatographic device, wherein the surfactant is selected from the group including polyoxyethylene octyl phenyl ether [para 109]. The Example of an Immunochromatographic Test Piece for Measuring Group a β-Hemolytic Streptococcus describe the Neutralizing reagent impregnated into the immunochromatographic test piece with 1.5% Triton X-100 [para 115]. This teaching teaches instant claim 1.
Similar to Hattori et al’s reagent impregnated nonwoven fabric; Hiroshi et al., clearly describe Unitika’s non-woven fabric as a nonwoven fabric which is easily biodegradable, highly flexible, and inexpensive, and a method of making same. Fiber materials available teach a fiber component of the nonwoven fabric include fibers of polyethylene, polypropylene, polyester and polyamide, natural fibers, and cellulose fibers. For purposes of fiber mixing, it is possible to employ various methods including, for example, combination-mixing during the stage of melt spinning, short fiber mixing at the stage of web forming, and web laminating, whereby a mixed-fiber nonwoven fabric can be produced. The poly-ε-caprolactone is a synthetic, biodegradable polyester [Summary of Invention]. Fiber materials available for above mentioned lamination with PCL and/or PPL include materials such as polyethylene, polypropylene, polyester, polyamide, natural and cellulose fibers. In the present invention, it is more desirable to laminate the web of PCL and/or PPL fibers with a natural fiber or cellulose fiber [Summary of Invention]. Thus teaching the non-woven fabric is polyester-polyethylene mixture which is a hydrophobic. Hiroshi et al., teach the nonwoven fabric having biodegradability which can be advantageously used as a biodegradable material.
Therefore, 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 immunochromatographic test strip of WO 2017213228 when Hattori et al., teach non-woven fabric nitrite and organic acids along with 1.5 w/v % of a polyoxyethylene octyl phenyl ether, Triton X-100™ impregnated on a region of the test piece, in order to achieve uniform development. Both WO 2017213228 and Hattori teach similar immunochromatographic test devices for the detection of antigens wherein an organic acid and a nitrite are mixed to provide nitrous acid for the extraction of the sugar chain antigen. Thus, one of ordinary skill in the art would find it obvious to incorporate 2-[4-(2,4,4-trimethylpentan-2- yl)phenoxy ethanol, the IUPAC name for Triton X-100™, because one would recognize that the incorporation would improve the preservation stability. Furthermore, Hattori et al., and Hiroshi et al., both teach the use of hydrophobic non-woven fiber and Hiroshi et al., further teach polyester and polyethylene mixed fiber substrate material is easily biodegradable, highly flexible, and inexpensive.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a
an immunochromatographic test strip 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 a non-woven fabric polyester-polyethylene mixture which is a hydrophobic material and 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; where there is no change in the respective function of any of the components, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
6. Applicant’s arguments, filed Jan 14, 2026, with respect to the rejection of claims 1, 4 and 6-11 under 35 U.S.C. 103 as being unpatentable over WO 2017213228 in view of Hiroshi et al., and Kato et al., has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Hattori et al., (WO 2018168907 published 2018-0920; priority to 2017-03-14 JP2017049213).
In response to applicant's arguments against each of the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, WO 2017213228 and Hattori et al., teach an impregnated hydrophobic non-woven fabric used on an immunochromatographic device. Hattori et al., teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a sample pad to which a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a resin-made sheet is sandwiched between the region impregnated with the solid acid reagent or the nitrite and the region impregnated with the neutralizing reagent so as to suppress the movement of a reagent or the movement of a specimen solution between the regions.
Hattori et al., teach an Immunochromatographic device with neutralizing reagent impregnated into the immunochromatographic test piece with 1.5% Triton X-100™ wherein the nonwoven fabric is comprised of a polyester mixture. Hiroshi et al., teach that nonwoven fabric is a polyester-polyethylene mixture.
Applicants argue that Hiroshi et al., do not teach nonwoven fabric comprising a polyester-polyethylene mixture. However, Hattori et a., teach an immunochromatographic device with an impregnated nonwoven polyester mixture fabric comprised of a polyester mixture, WO 2017213228 teach an immunochromatographic device with an impregnated nonwoven fabric. Therefore the use of polyester mixture as nonwoven fabric used within an immunochromatographic device is well known in the art. Hiroshi et al., does teach nonwoven fabric comprising a polyester-polyethylene mixture. Moreover this argument is not persuasive because each and every limitation is taught by the prior art..
Applicants argue that while WO 2017213228 teach an immunochromatographic device with an impregnated nonwoven fabric; it does not teach the nonwoven fabric comprising a polyester-polyethylene mixture. Applicants attention is directed to Hattori et al., and Hiroshi et al., which do teach a nonwoven fabric comprised of a fiber mixture.
Applicants urge that the references do not teach the a hydrophobic material and 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. However Hattori et al., clearly teach a hydrophobic material and 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, by using 1.5% (w/v) a polyoxyethylene octyl phenyl ether is used for the region impregnated with the nitrite or the solid acid reagent.
Therefore, none of applicants arguments are persuasive.
Claim Rejections - 35 USC § 103
7. Claims 1, 4 and 6-11 are rejected under 35 U.S.C. 103 as being obvious over Shida et al., et al., (US 2008/0194013 published Aug 2008; priority to June 7, 2005) in view of in Hattori et al., (WO 2018168907 published 2018-09-20; priority to 2017-03-14 JP2017049213) and Hiroshi et al., (US Patent 5,506,041 published 1996-04-09). Documents available on Google Patents.
The applied reference has a common inventor with the instant application. Based upon the earlier published date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1).
Shida et al., teach an immunochromatographic device comprising an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen (e.g., par. 81), and a container that stores the test piece (par. 85: apparatus may be accommodated in a container (housing)), the immunochromatographic test piece comprising: a sample pad to which a specimen mixed with an acid solution is added (par. 81: in order to separate the carbohydrate antigen from the bacterial cells, bacteria are suspended in an acidic solution, and the resultant is supplied to the specimen-supply site 2); a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen (par. 81: the carbohydrate antigen develops to the labeled reagent site 3 under neutral conditions, and it can specifically and stably bind to a labeled reagent); 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 (Fig. 7: capture reagent site 4; par. 8: a capture reagent site to which a capture reagent capable of specifically binding to and capturing a complex of the analyte and the labeled reagent has been immobilized; par. 83: an analyte binds to a labeled reagent and a capture reagent to form an analyte-ligand complex; typically, a ligand that binds to an analyte is an antibody that specifically binds to an antigen when the analyte is an antigen), wherein a specimen addition port is in the sample pad (par. 81: the specimen-supply site 2), wherein the immunochromatographic test piece comprises a region impregnated with a neutralizing agent upstream of the label region (par. 81: a functional site 1, i.e., a member impregnated with a basic reagent that neutralizes a pH level under acidic conditions is provided between the specimen-supply site 2 and the labeled reagent site 3), and
a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent (par. 82: a functional site 1', i.e., a member impregnated with sodium nitrite, is provided between the specimen-supply site 2 and the functional site 1), and
wherein the region impregnated with the nitrite, or the region impregnated with the neutralizing reagent on the immunochromatographic test piece is a filter composed of a material having a high degree of hydrophilicity (par. 65: examples of a member constituting a functional site to be provided on the solid-phase support in advance include, but are not limited to, polyester, and artificial polymers composed of mixtures of the fibers; par. 65: when a functional site is provided with a function of filtration, for example, any member that can act as a filter can be used). Shida et al., teach the use of unwoven fabric (par. 95). The chromatography detection apparatus according to any of [13] to [15], wherein the reagent is selected from the group consisting of a buffer, an acidic reagent, a basic reagent, and a surfactant (par. 26). FIG. 6 shows an apparatus, a functional site 1′, i.e., a member impregnated with sodium nitrite, is provided between the specimen-supply site 2 and the functional site 1, since extraction of a carbohydrate antigen with the use of nitrous acid involves risks due to strong acidity. Instead of the use of such a member, a functional site impregnated with sodium nitrite may be provided on the solid-phase support (par. 82). When bacterial or virus infection is to be detected, for example, a substance such as a protein existing in a cell wall of bacteria is detected in order to detect the presence of bacteria or viruses in the specimen (par. 67). More particularly, the Shida et al., et al., provides an immunochromatography detection apparatus, a detection method, and a kit using the same (par. 56). Shida et al., teach the preparation of the pad with a surfactant (par 96).
Finally, Shida et al., teaches that extraction of a carbohydrate antigen from a sample can be achieved through use of nitrous acid, and additionally teaches that it is advantageous to provide the organic acid and the nitrite involved in the creation of the nitrous acid as separate components, in order to avoid risks of handling a strong acid; Shida et al., teaches that one component may be mixed with the sample prior to addition to the test piece, while the second component may be provided as a dried reagent impregnated onto a region of the test piece (Par. 82). Shida et al., seeks to optimize the reaction conditions of the immunochromatographic device (par. 6). Shida et al., seeks to regulate the speed of development of a solution on the solid-phase support depending on the amount of the solution absorbed (par. 66). Shida et al., teach the solid-phase support, natural or synthetic polymers such as polyester or a mixture of such substances (par. 59). However, Shida et al., fail to specifically teach the region impregnated with the nitrite, or the region impregnated with the neutralizing reagent on the immunochromatographic test piece wherein a non-woven fabric which is a hydrophobic material and 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.
Hattori et al., has been discussed above as teaching an immunochromatographic device with neutralizing reagent impregnated into the immunochromatographic test piece with 1.5% Triton X-100™ wherein the nonwoven fabric is comprised of a polyester mixture.
Hiroshi et al., has been discussed above as teaching the region impregnated with the nitrite, or the region impregnated with the neutralizing reagent on the immunochromatographic test piece wherein a non-woven fabric which is a hydrophobic polyester-polyethylene material impregnated with 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 is optimized for extraction time and signal strength.
Therefore, it would have been prima facie obvious from the teachings of Shida, Hattori et al., and Hiroshi et al., before the effective filing date of the claimed invention to have modified the immunochromatographic device of Shida et al., such that the nitrite is mixed with the sample and a solid acid reagent such as tartaric acid is impregnated on a region of the test piece, as taught by Hattori et al., and Hiroshi. Both Shida et al., and Hattori et al., teach similar immunochromatographic test devices for the detection of sugar chain antigen wherein an organic acid and a nitrite are mixed to provide nitrous acid for the extraction of the sugar chain antigen. Additionally, Shida et al., and Hattori et al.,, teach one component (the organic acid or the nitrite) is provided and mixed with the sample prior to addition of the sample solution to the test piece, while the other component is impregnated onto a region of the test piece. Hiroshi et al., teach the advantages of a polyester-polyethylene material. Moreover, Shida et al., and Hattori teach that this separation of the organic acid and the nitrite provides a safer and more convenient solution for the production of nitrous acid. Thus, one of ordinary skill in the art would find it obvious to make this modification, because one would recognize that the substitution of the organic acid solution and nitrite-impregnated region of polyester-polyethylene as taught by Hiroshi et al., and Shida et al., and Hattori et al., for the nitrite solution and solid acid-impregnated region in order to achieve predictable results (i.e. reaction between the nitrite and the organic acid on the test strip to produce nitrous acid for the extraction of a sugar chain antigen). Shida et al., teach that the sample may be pretreated with acetic acid “or the like” (Par. 82), wherein the explicit function of the acid is to react with nitrite to produce nitrous acid. Similarly, Hattori et al., teach that a variety of organic acids including tartaric acid can be used in the immunochromatographic test piece, and teach that both acetic acid and tartaric acid will achieve the desired function of reacting with nitrite to produce nitrous acid for the extraction of sugar chain antigen. One of ordinary skill in the art would have a reasonable expectation of success in making these modifications because Shida et al., and Hattori et al., are directed to similar immunochromatographic test devices for the extraction and detection of sugar chain antigens.
Response to Arguments
8. Applicant’s arguments, filed Jan 14, 2026, with respect to the rejection of claims 1, 4 and 6-11 under 35 U.S.C. 103 as being unpatentable over Shida in view of Hiroshi et al., and Kato et al., has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Hattori et al., (WO 2018168907 published 2018-0920; priority to 2017-03-14 JP2017049213).
Applicants argue that Shida et al., do not teach the region impregnated with the nitrite, or the region impregnated with the neutralizing reagent on the immunochromatographic test piece wherein a non-woven fabric which is a hydrophobic material and 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.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Shida et al., and Hattori et al., teach 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. Additionally, Hattori et al., teach a hydrophobic polyester mixture material and 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. Finally, Hiroshi et al., teach the benefits of using a nonwoven fiber mixture of polyester-polyethylene.
Applicant amended the claims to recite 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.
Here, Shida et al., teach an surfactant impregnated hydrophobic non-woven fabric; Hattori et al., teach a nonwoven polyester mixture fabric; while Hiroshi et al., teach that fabric is a polyester-polyethylene mixture. Therefore, this limitation is taught by the prior art.
Finally, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The MPEP section 2123 teaches that patents are relevant as prior art for all they contain, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir.1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”). Therefore, Hattori et al., teach 1.5 weight % polyoxyethylene octyl phenyl ether, Triton X-100™ impregnated on a region of the test piece wherein the concentration is optimized for extraction time and signal strength.
Accordingly, the prior art references teach a concentration range for polyoxyethylene octyl phenyl ether concentration which is optimized for extraction time and signal strength. Therefore each and every limitation is taught by the prior art references.
Maintained Grounds of Rejection
Double Patenting
9. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1, 6-9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 4-7 of U.S. Patent No. 11,906,513 in view of Shiga et al., (US Patent 8,679,812).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, it 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 the nitrite is used, or a region impregnated with the nitrite when the specimen mixed with the acid solution is used, wherein the non-woven fabric is a polyester-polyethylene mixture which is a hydrophobic material and 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.
Patent claim 1 teach an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece 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; 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, wherein a single flow channel of a continuous lateral flow is formed, and 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 solid acid reagent region or the nitrite region and the neutralizing reagent region 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.
Additionally, the Patent teach the immunochromatographic device, wherein the highly hydrophobic material is selected from the group consisting of polyethylene, polyester, polystyrene, polypropylene, rayon, and nylon. The neutralizing reagent is disposed downstream of the region impregnated with the solid acid reagent or the nitrite. The neutralizing reagent may be impregnated into the support, or may be impregnated into the support, or may be impregnated into a pad made of a porous material that is different from the support, such as a non-woven fabric, and the obtained neutralizing reagent-impregnated porous material may be disposed between the region impregnated with the solid acid reagent or the nitrite and the label region where the Solid acid reagent (impregnated into the immunochromatographic test piece): 1.0 M organic acid (tartaric acid), and Triton X-100™.
Shiga et al., teach Immunochromatography generally makes use of a capture reagent site and a labeling reagent site. The antibody which is to capture the antigen is immobilized at the capture reagent site. There are no particular limitations on the material of the solid phase carrier used at the capture reagent site, so long as it is an inert material composed of a microporous substance exhibiting capillary action, which does not react with the first reagent, labeling reagent and substance to be detected. Specifically, it may be a fibrous or nonwoven fibrous matrix, composed of polyester, polyethylene, or, filter paper, glass fiber filter paper, cloth, cotton or the like. Examples of preferred surfactants include polyoxyethylene isooctylphenyl ethers (for example, 2% TritonX-100™ at Table 2.
Patent claim 1 differs from the instant claims in that the patent further includes a single flow channel of a continuous lateral flow is formed, and a resin-made sheet is sandwiched between the solid acid reagent region or the nitrite region and the neutralizing reagent region such that the solid acid reagent region or the nitrite region and the neutralizing reagent region 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. It is noted that additional components do not distinguish over the instantly claimed apparatus. The transitional 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 solid acid reagents, neutralizing regents and antibodies against sugar chains of protozoan fungi, bacteria, mycoplasma, rickettsia, chlamydia or viruses. Therefore, the immunochromatographic test strip are not patentable distinguishable.
Response to Arguments
11. Applicant’s arguments, filed Jan 14, 2026, with respect to the double patenting rejection of claims 1, 6-9 and 11 do not overcome the rejection. Contrary to Applicants argument the Patent claims highly hydrophobic material is selected from the group consisting of polyethylene, polyester and the like. Furthermore, Shiga et al., teach 2% Triton X-100 just as the claims recite. Therefore, both the instant claims and patented claims teach hydrophobic material comprising polyethylene and polyester. Thus the rejection is maintained.
Double Patenting
12. Claims 1 and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of U.S. Patent No. 12,013,394 in view of WO2011081075 (Shiga et al.) Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claim 1, is drawn to an immunochromatographic test piece for extracting and measuring a sugar chain antigen of microorganisms belonging to genus Streptococcus in a specimen, the immunochromatographic test piece comprising: a sample pad to which a specimen mixed with nitrite or an acid solution is added; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test piece having a region impregnated with a neutralizing reagent upstream of the label region, and further having a region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a region impregnated with nitrite when the specimen mixed with the acid solution is used, upstream of the region impregnated with the neutralizing reagent, wherein a material for the region impregnated with the neutralizing reagent is a filter or a glass filter having three properties of being highly absorbable, being highly water-retainable, and being low releasable or continuously releasable, 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, and
owing to the high water-absorbable property and the high water-retainable property of the region impregnated with the neutralizing reagent, the acid solution containing the sugar chain antigen is 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.
Shiga et al., teach the solid phase carrier where there are no particular limitations on the material of the solid phase carrier used at the capture reagent site, so long as it is an inert material composed of a microporous substance exhibiting capillary action, which does not react with the first reagent, labeling reagent and substance to be detected. Specifically, it may be nonwoven fibrous matrix, composed of polyester and polyethylene. Examples of surfactants include 2% Triton X-100™. The concentration of the surfactant in the extraction reagent of the invention will preferably 0.01-5% (w/w), even more preferably 0.05-1.0% (w/w) and yet more preferably 1.0% (w/w). Also, limiting the surfactant concentration to no greater than 5.0% (w/w) is economical since no further improvement in extraction efficiency is seen when the concentration is increased beyond this limit, and is preferred to avoid causing problems such as increased complexity of the procedure due to removal or dilution of the surfactant so that the surfactant does not adversely affect the subsequent measuring system.
Patented claim 1 differs from the instant claims in that the patent further includes neutralizing reagent is a filter or a glass filter having three properties of being highly absorbable, being highly water-retainable, and being low releasable or continuously releasable, 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, and owing to the high water-absorbable property and the high water-retainable property of the region impregnated with the neutralizing reagent, the acid solution containing the sugar chain antigen is 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.
It is noted that additional components and functions do not distinguish over the instantly claimed apparatus. The transitional 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 solid acid reagents, neutralizing regents and antibodies against sugar chains of protozoan fungi, bacteria, mycoplasma, rickettsia, chlamydia or viruses. Therefore, the immunochromatographic test strip are not patentable distinguishable.
Response to Arguments
13. Applicant’s arguments, filed Jan 14, 2026, with respect to the double patenting rejection of claims 1, 6 and 8 do not overcome the rejection. Contrary to Applicants argument the Patent claims highly hydrophobic material is selected from the group consisting of polyethylene, polyester and the like. Furthermore, Shiga et al., teach 1-2% Triton X-100 just as the claims recite. Therefore, both the instant claims and patented claims teach hydrophobic material comprising polyethylene and polyester. Thus the rejection is maintained.
Double Patenting
14. Claims 1, 3 and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-14 of copending Application No. 16/492,431 in view of WO2011081075 (Shiga et al.).
Regarding claim 1, 16/492,431 teaches an immunochromatographic device comprising an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, and a container that stores the test piece, 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 1s immobilized, wherein a specimen addition port is in the sample pad, 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 comprises 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 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 the solid acid reagent is selected from the group consisting of malic acid, maleic acid, and tartaric acid, wherein the region impregnated with the solid acid reagent or the nitrite, region impregnated with the neutralizing reagent on the immunochromatographic test piece is a thick filter having a thickness of 210 to 580 um and composed of a hydrophilic material, and wherein (i) the specimen addition port has a size of 24 to 75 mm2, and (ii) there is no space between the specimen addition port and the sample pad so as to prevent the specimen from escaping from the specimen addition port.
Shiga et al., teach a non-woven fabric polyester and polyethylene which is a hydrophobic material and 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.
16/492,431 in view of Shiga et al., differs from the instant claims in that it further comprises a thick filter having a thickness of 210 to 580 um and composed of a hydrophilic material, and wherein (i) the specimen addition port has a size of 24 to 75 mm2, and (ii) there is no space between the specimen addition port and the sample pad so as to prevent the specimen from escaping from the specimen addition port. It is noted that additional components do not distinguish over the instantly claimed apparatus. The transitional 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 solid acid reagents, neutralizing regents and antibodies against sugar chains of protozoan fungi, bacteria, mycoplasma, rickettsia, chlamydia or viruses. Therefore, the immunochromatographic test strip are not patentable distinguishable.
Response to Arguments
15. Applicant’s amendments filed Jan 14, 2026, with respect to the double patenting rejection of claims 1, 3 and 5-9 do not overcome the double patenting rejection. Contrary to Applicants argument and amendment the provisional claims in view of the prior art teach highly hydrophobic material is selected from the group consisting of polyethylene, polyester and the like. Additionally, the references teach 1.0-2.0 (w/v)% polyoxyethylene isooctylphenyl ethers. The provisional claims do not exclude the hydrophobic nonwoven material. Therefore the rejection is maintained.
Double Patenting
16. Claims 1, 3 and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 7 of copending Application No. 17/426,563 in view of WO2011081075 (Shiga et al.).
Regarding provisional claim 1, 17/426,563 recite an immunochromatographic test kit comprising: (i) a nitrite solution or an acid solution; 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 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 is used, or a region impregnated with the nitrite in case the specimen mixed with the acid solution is used, wherein the nitrite or acid solution comprises one or more selected from the group consisting of polyoxyethylene octyl phenyl ether, a quaternary ammonium compound, phosphoric acid, sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA and NaBr.
Shiga et al., teach a non-woven fabric polyester and polyethylene mixture which is a hydrophobic material and 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.
17/426,563 differs from the instant claims in that the nitrite or acid solution comprises one or more selected from the group consisting of polyoxyethylene octyl phenyl ether, a quaternary ammonium compound, phosphoric acid, sodium hydroxide, N-acetyl-L-cysteine, NaCl, PVA, BSA and NaBr. However instant claims 3-4 include polyoxyethylene octyl phenyl ether, while instant claim 8 recites sodium hydroxide. Furthermore, both sets of claims recite a region impregnated with the solid acid reagent, the same solid acid reagents, the same neutralizing regents and antibodies against sugar chains of protozoan fungi, bacteria, mycoplasma, rickettsia, chlamydia or viruses. Therefore, the immunochromatographic test strip are not patentable distinguishable.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
17. Applicant’s arguments, filed Jan 14, 2026, with respect to the double patenting rejection of claims 1, 3 and 5-9 do not overcome the double patenting rejection.
Contrary to Applicants argument and amendment the patent claims in view of Shiga teach highly hydrophobic material is selected from the group consisting of polyethylene, polyester and the like. Additionally, the references teach 1.0-2.0 (w/v)% polyoxyethylene isooctylphenyl ethers. The provisional claims do not exclude the hydrophobic nonwoven material. Therefore the rejection is maintained.
Pertinent Art
18. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
See WO 2019138898, EP2835643, WO20150444523 and US Patent 8,865,088.
EP0070163 a thermal bonded non-woven fabric composed of polyester/polyethylene conjugate fibers, said fabric having an excellent combination of low bulk density, softness, and strength. The fabric is especially useful as a facing in absorbent products. US Patent 4654309 neutral and non-buffering, porous, absorbant support material having at least one portion thereof which contains a composition comprising an effective amount of acid-base indicator capable of changing color. All documents are available on Google Patents.
Conclusion
19. No claims allowed.
20. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dan Kolker, can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/Primary Examiner, Art Unit 1645