Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 13-19, and 21-27 are pending in the application.
Claims 15-19 are withdrawn.
Claims 13-14 and 21-27 are pending in the application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 December 2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 December 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-14 and 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 13 and 21 are vague regarding “the surfactant” there is prior introduction of a “nonionic surfactant” but no introduction of a generic “surfactant”, as such there is insufficient antecedent basis for this limitation in the claims.
Claim 21 is vague regarding “the formula” there is prior introduction of a specific formula (2) and formula (3), but no prior introduction of a generic “formula”. As such there is insufficient antecedent basis for this limitation in the claim. Additionally, the recitation of the generic “the formula” is indefinite because it is unclear whether this refers to formula (2), formula (3), both, or neither. Clarification is required.
Dependent claims 14 and 21-27 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13-14 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al (US 2016/0069909 A1; IDS entered) in view of Zhang et al (CN 105675879 A; previously cited) and Sumida et al (WO 2017/009926 A1; previously cited).
Regarding claims 13, 21-25, and 27 Nakamura teaches a reagent kit for measuring a test substance in a biological sample (abstract), wherein the test substance may be a protein (Par. 5, 35). The kit comprising:
First particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (Abstract; Par. 48, 50), wherein the first binding substance may be an antibody (Par. 44) and the first particles may be fluorescent latex particles comprising a fluorescent dye (Par. 50) and having a diameter in a range of 70nm-500nm (Par. 52);
At least one nonionic surfactant having a molecular weight of 1000 or less (Par. 54: first particles may be blocked by a substance such as PEG to reduce nonspecific binding (wherein PEG is a nonionic surfactant with molecular weight less than 1000); and
Nakamura teaches that measurement of the test substance may be performed in the format of a sandwich immunoassay comprising antibodies (Par. 44), and teaches that the sandwich method may comprise a washing step for the purpose of removing first particles which have not been bound in the test area and the control area of the substrate (Par. 87), however, Nakamura does not specifically teach the type of wash buffer used in the washing step of the sandwich method.
Nakamura further teaches the kit comprising a substrate on which a first metal film on which a third binding substance having a property of specifically binding to the test substance or the first binding substance is formed (Par. 22).
Nakamura does not specifically teach that the first binding substance has a property of specifically binding to SAA.
Nakamura does not specifically teach the surfactant has a maltose or glucose skeleton.
Regarding claims 13, 21-25 and 27, Zhang teaches a reagent kit and measurement method for the detection of SAA in a biological sample, and teaches that SAA is a biomarker of clinical interest because of its association with inflammation and infection (Par. 2, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Nakamura such that the test substance is serum amyloid A, because Nakamura teaches that the kit can be used for measurement of a variety of different proteins, while Zhang teaches that SAA is a protein of clinical interest that can be measured by an immunoassay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Nakamura and Zhang are both directed to detection of proteins in a biological sample via an immunoassay.
Similar to Nakamura, Zhang teaches measurement of the test substance using a kit comprising first particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (SAA) (Par. 26); at least one nonionic surfactant having a molecular weight of 1000 or less (Par. 25-26) and a buffer (Par. 24-25, 56, 65, 71). Zhang also teaches that SAA is detected by a sandwich immunoassay (Par. 31, 59, 61). Zhang teaches specifically that buffers within the claimed ranges of pH are suitable for use in such an assay which uses these reagents (Par. 24-25, 56, 65, 71), wherein the buffer may be 2-(N-morpholino)ethanesulfonic acid (MES buffer) (Par. 25).
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 kit taught by Nakamura in view of Zhang to further include a buffer with a pH in the range of 5.5 to 7.0 such as the MES buffer taught by Zhang. One of ordinary skill in the art would be motivated to make this modification because Nakamura teaches a sandwich immunoassay which comprises the use of a wash buffer, but is generic regarding the specific buffer and its pH, while Zhang teaches a sandwich format immunoassay comprising similar reagents and teaches that a buffer with a pH in the range of 5.5 to 7.0 is suitable for use with these reagents in this assay format. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Nakamura and Zhang disclose sandwich immunoassays comprising fluorescent latex particles and binding substances for the detection of a test substance in a biological sample.
Sumida discloses a method for fixing a specific binding substance on a carrier (abstract). Sumida teaches that a specific binding substance and a specific membrane solubilizing agent are mixed in advance, and a mixed solution containing the specific binding substance and the membrane solubilizing agent is applied to the surface of the carrier (Abstract). Sumida teaches that membrane solubilizing agents are selected from the group consisting of n-octyl-β-D-glucoside, n-octyl-β-D thioglucoside, n-dodecyl-β-D-maltoside, and n-nonyl-β-D-thiomaltoside, and n-octanyl-N-methyl-D-glucamine (Abstract). Wherein at least n-dodecyl-β-D-maltoside is a nonionic surfactant having a molecular weight of 1000 or less and having a glucose skeleton or a maltose skeleton and which meets the surfactant limitations presented in claim 21.
Sumida teaches applying onto a surface of the carrier a liquid mixture containing the specific binding substance and the membrane solubilizing agent, thereby fixing the specific binding substance to the surface (Abstract). Sumida teaches that the disclosed membrane solubilizers (surfactants) are useful for improving immunoassay methods by decreasing nonspecific binding (Abstract). Sumida teaches that the carrier may be a latex particle (Pg. 6, Par. 5, and that the specific binding substance may be an antibody (Pg. 3, Par. 5).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the solubilizing agent of Sumida in the method and kit of Nakamura in view of Zhang for fixing/immobilization of specific binding substance with the expectation of reducing non-specific binding with a reasonable expectation of success, since both references disclose immobilization of a specific binding substance (e.g. Nakamura teaches immobilization of first binding substance to first particles).
Regarding claim 14, Nakamura further teaches the kit wherein a second metal film on which a fourth binding which has a property of specifically binding to the first binding substance and does not have a property of binding to SAA is immobilized, is further formed on the substrate (Par. 23).
Regarding claim 26, Nakamura further teaches the kit further comprising second particles which are modified with a second binding substance having no property of specifically binding to SAA and do not have a label (Par. 18, 60).
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 13-14 and 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5 and 9-10 of U.S. Patent No. 12,163,962 B2 in view of Nakamura et al (US 2016/0069909 A1; IDS entered) and Zhang et al (CN 105675879 A; previously cited).
Regarding instant claims 13, 21, and 27, reference claims 1 and 9 teach all limitations of the instant claim with the exception of the buffer.
Regarding instant claims 13, 21, and 27, Nakamura teaches a measurement kit comprising:
First particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (Abstract; Par. 48, 50), wherein the first binding substance may be an antibody (Par. 44) and the first particles may be fluorescent latex particles comprising a fluorescent dye (Par. 50) having a diameter in a range of 70nm-500nm (Par. 52);
At least one nonionic surfactant having a molecular weight of 1000 or less (Par. 54: first particles may be blocked by a substance such as PEG to reduce nonspecific binding (wherein PEG is a nonionic surfactant with molecular weight less than 1000); and
Nakamura teaches that measurement of the test substance may be performed in the format of a sandwich immunoassay comprising antibodies (Par. 44), and teaches that the sandwich method may comprise a washing step for the purpose of removing first particles which have not been bound in the test area and the control area of the substrate (Par. 87), however, Nakamura does not specifically teach the type of wash buffer used in the washing step of the sandwich method.
Nakamura further teaches the kit comprising a substrate on which a first metal film on which a third binding substance having a property of specifically binding to the test substance or the first binding substance is formed (Par. 22).
Similar to Nakamura, Zhang teaches measurement of the test substance using a kit comprising first particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (SAA) (Par. 26); at least one nonionic surfactant having a molecular weight of 1000 or less (Par. 25-26) and a buffer (Par. 24-25, 56, 65, 71). Zhang also teaches that SAA is detected by a sandwich immunoassay (Par. 31, 59, 61). Zhang teaches specifically that buffers within the claimed ranges of pH are suitable for use in such an assay which uses these reagents (Par. 24-25, 56, 65, 71), wherein the buffer may be 2-(N-morpholino)ethanesulfonic acid (MES buffer) (Par. 25).
Therefore, it would have been obvious to one of ordinary skill in the art to modified the kit of the reference claims to further include a buffer with a pH in the range of 5.5 to 7.0 such as the MES buffer taught by Zhang. One of ordinary skill in the art would be motivated to make this modification because Nakamura teaches that a kit such as the one claimed may be used for a sandwich immunoassay which comprises the use of a wash buffer to remove unbound reagents and improve assay sensitivity, but is generic regarding the specific buffer and its pH, while Zhang teaches a sandwich format immunoassay comprising similar reagents and teaches that a buffer with a pH in the range of 5.5 to 7.0 is suitable for use with these reagents in this assay format. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims and the cited prior art are directed to similar kits comprising similar reagents and materials.
All additional limitations of instant claim 14 are taught by reference claim 10.
All additional limitations of instant claim 21 are taught by reference claim 1.
Regarding instant claim 22, the reference claims teach the first particle as claimed in instant claim 13, but are generic regarding the material of the particle and do not explicitly teach that the particles are latex particles.
Nakamura teaches a measurement kit comprising:
First particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (Abstract; Par. 48, 50), wherein the first binding substance may be an antibody (Par. 44) and the first particles may be fluorescent latex particles comprising a fluorescent dye (Par. 50) having a diameter in a range of 70nm-500nm (Par. 52);
It would have been obvious to one of ordinary skill in the art to modify the reference claims such that the first particles taught by the reference claims comprise latex particles, as taught by Nakamura. One of ordinary skill in the art would be motivated to make this modification because the reference claims teach first particles but are generic regarding the material of the particles, while Nakamura teaches that latex particles are suitable for use in a similar kit for a similar immunoassay. As such, one would be motivated to include the proper reagents and materials for the claimed kit and application. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims are Nakamura are directed to similar measurement kits comprising similar reagents and materials.
Regarding instant claim 23-24, reference claims 4-5 states that the label recited in reference claim 1 is a fluorescent dye and that the first particles recited in reference claim 1 have a diameter of 70nm-500nm. Although reference claims 4, 5, and 9 are not specifically tied together in the reference claim set, it would have been obvious to one of ordinary skill in the art to modify the invention of reference claim 9 to specifically include the fluorescent label recited in reference claim 4 and to include particles of the diameter stated in reference claim 5. One of ordinary skill in the art would be motivated to make this modification because reference claim 1 recites a label but is generic regarding the type of label, while reference claim 4 teaches that a fluorescent label is appropriate to use with the kit of reference claim 1. Similarly, reference claim 1 recites first particles but is generic regarding their size, while reference claim 5 teaches that first particles may have a diameter within the range of 70-500nm. As such, one would be motivated to use a fluorescent label and a particle with a diameter of 70-500nm in the kit of reference claim 9 because one would be motivated to use the proper reagents for the claimed application. One of ordinary skill in the art would have a reasonable expectation of success because both the label type and particle size are recited to be suitable for use with the kit of reference claim 1.
Regarding instant claim 25, reference claim 1 recites a first binding substance but is generic regarding the particular species of binding substance.
Regarding instant claim 25, the teachings of Nakamura are outlined in detail above. Nakamura specifically teaches that the first binding substance may be an antibody.
It would have been obvious to one of ordinary skill in the art to modify the invention of the reference claims such that the first binding substance is specifically an antibody as taught by Nakamura. One of ordinary skill in the art would be motivated to make this modification because the reference claims are generic regarding the species of binding substance, and one would be motivated to choose the appropriate species of binding substance for the chosen application, wherein Nakamura teaches that antibodies are an appropriate binding substance. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims and Nakamura describe similar kits comprising similar materials and reagents for the detection of a target protein in a biological sample.
Regarding instant claim 26, the reference claims do not specifically teach the kit further comprising second particles which are modified with a second binding substance having no property of specifically binding to SAA and do not have a label.
Nakamura further teaches the kit further comprising second particles which are modified with a second binding substance having no property of specifically binding to SAA and do not have a label (Par. 18, 60).
It would have been obvious to one of ordinary skill in the art to modify the invention of the reference claims such that the kit further comprises second particles which are modified with a second binding substance having no property of specifically binding to SAA and do not have a label, as taught by Nakamura. One would be motivated to make this modification because Nakamura teaches that these particles can be used as a control to prevent false positives in the assay (Par. 57). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims and Nakamura are directed to similar kits comprising similar materials and reagents for the detection of a target protein in a biological sample.
Claims 13-14 and 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, and 13-19 of copending Application No. 17/390,010 in view of Nakamura et al (US 2016/0069909 A1; IDS entered) and Sumida et al (WO 2017/009926 A1; previously cited).
Regarding instant claims 13 and 21, reference claims 1 and 9 (and/or 13-19) teach all the limitations of the instant claim with the exception that the reference claims do not specifically teach that the nonionic surfactant is a compound having a glucose skeleton or a maltose skeleton.
Sumida discloses a method for fixing a specific binding substance on a carrier (abstract). Sumida teaches that a specific binding substance and a specific membrane solubilizing agent are mixed in advance, and a mixed solution containing the specific binding substance and the membrane solubilizing agent is applied to the surface of the carrier (Abstract). Sumida teaches that membrane solubilizing agents are selected from the group consisting of n-octyl-β-D-glucoside, n-octyl-β-D thioglucoside, n-dodecyl-β-D-maltoside, and n-nonyl-β-D-thiomaltoside, and n-octanyl-N-methyl-D-glucamine (Abstract). Wherein at least n-dodecyl-β-D-maltoside is a nonionic surfactant having a molecular weight of 1000 or less and having a glucose skeleton or a maltose skeleton and which meets the surfactant limitations presented in instant claim 21.
Sumida teaches applying onto a surface of the carrier a liquid mixture containing the specific binding substance and the membrane solubilizing agent, thereby fixing the specific binding substance to the surface (Abstract). Sumida teaches that the disclosed membrane solubilizers (surfactants) are useful for improving immunoassay methods by decreasing nonspecific binding (Abstract). Sumida teaches that the carrier may be a latex particle (Pg. 6, Par. 5, and that the specific binding substance may be an antibody (Pg. 3, Par. 5).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the solubilizing agent of Sumida in the reference kit for fixing/immobilization of specific binding substance with the expectation of reducing non-specific binding with a reasonable expectation of success, since both references disclose immobilization of a specific binding substance (e.g. the reference kit teaches immobilization of first binding substance to first particles).
All additional limitations of instant claim 14 are taught by reference claim 10.
Regarding instant claim 22, reference claims 1 and 9 teach the kit comprising first particles but are generic regarding the species of particles.
Nakamura teaches a measurement kit comprising:
First particles having a label and modified with a first binding substance having a property of specifically binding to the test substance (Abstract; Par. 48, 50), wherein the first binding substance may be an antibody (Par. 44) and the first particles may be fluorescent latex particles comprising a fluorescent dye (Par. 50) having a diameter in a range of 70nm-500nm (Par. 52);
At least one nonionic surfactant having a molecular weight of 1000 or less (Par. 54: first particles may be blocked by a substance such as PEG to reduce nonspecific binding (wherein PEG is a nonionic surfactant with molecular weight less than 1000); and
Nakamura teaches that measurement of the test substance may be performed in the format of a sandwich immunoassay comprising antibodies (Par. 44), and teaches that the sandwich method may comprise a washing step for the purpose of removing first particles which have not been bound in the test area and the control area of the substrate (Par. 87), however, Nakamura does not specifically teach the type of wash buffer used in the washing step of the sandwich method.
Nakamura further teaches the kit comprising a substrate on which a first metal film on which a third binding substance having a property of specifically binding to the test substance or the first binding substance is formed (Par. 22).
It would have been obvious to one of ordinary skill in the art to modify the reference claims such that the first particles taught by the reference claims comprise latex particles, as taught by Nakamura. One of ordinary skill in the art would be motivated to make this modification because the reference claims teach first particles but are generic regarding the material of the particles, while Nakamura teaches that latex particles are suitable for use in a similar kit for a similar immunoassay. As such, one would be motivated to include the proper reagents and materials for the claimed kit and application. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims are Nakamura are directed to similar measurement kits comprising similar reagents and materials.
All additional limitations of instant claim 23 are taught by reference claims 2, 4, 13, and 15.
All additional limitations of instant claim 24 are taught by reference claims 5 and 16.
All additional limitations of instant claim 25 are taught by reference claims 8 and 19.
All additional limitations of instant claim 26 are taught by reference claims 3 and 14.
All additional limitation of instant claim 27 are taught by reference claims 7 and 18.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed 31 December 2025 have been fully considered.
Regarding the 103 rejections, applicant argues that the previous 103 rejection does not address all features of the amended claims. The previous 103 rejection is withdrawn in favor of the new grounds of 103 rejection presented above which addresses the amended claims.
Regarding the double patenting rejections, the previous double patenting rejections do not address the amended claims and are withdrawn. New grounds of double patenting rejection which address the amended claims are presented above. The previous double patenting rejection over Application No. 17/021,168 is moot and is withdrawn in view of the abandonment of the application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677