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. Election/Restrictions Applicant’s election without traverse of Group I, wherein the compound having formula (1) in the claims is phenylglyoxal, in the reply filed on December 1, 2025 is acknowledged. The elected Group I is encompassed by claims 1-4, 6-10 and 12-14. Claims 5 and 11 are withdrawn from further consideration since both claims 5 and 11 recite limitations referring to when the compound recited in independent claims 1 and 7 is a benzimidazole derivative. Elected Group I covers when the compound in independent claims 1 and 7 is phenylglyoxal, not when the compound is a benzimidazole derivative. In addition, a lthough Applicant elected Group I without traverse, Applicant argues that it would not be an undue burden on the Examiner to search all of the Groups since the Groups overlap in feature. This argument is not persuasive since the number of alternatives for a compound having formula (1) in the claims or being a benzimidazole derivative having an electron-donating substituent at position 2 is very large, and thus, searching for each and every one of these alternatives would be a significant burden. It is also noted that the benzimidazole derivatives and the histidine as possibilities for the compound in the instant claims do not share any structural similarity with the compounds of formula (1). Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-4, 7-10 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1-4, 7-10 and 13-14 recite a method, a measurement reagent and a kit for measuring a component to be measured in a specimen by reacting the component to be measured with an enzyme to produce hydrogen peroxide in the presence of hydrogen peroxide derived from a component other than the component to be measured. These claims broadly include any component to be measured in a ny type of specimen. However, the written description of the invention in the specification only describes performing the method recited in the claims on a blood sample in order to determine hemoglobin A1c as the component to be measured in the sample. All of the examples in the specification describe performing the steps of the method recited in the instant claims using the reagents recited in the instant claims on a blood sample in order to determine an amount of HbA1 in the sample . See pages 31-45 of the specification where examples for measuring HbA1c in blood samples are described. The specification fails to provide evidence that the instantly claimed method can be performed on other types of samples to measure other components besides HbA1c. Therefore, it is unclear whether the use of one of the compounds recited in the claims, and specifically the elected phenylglyoxal, is able to circumvent hydrogen peroxide derived from a component other than a component to be measured in a specimen when the component to be measured is something other than HbA1c in a sample other than blood. For this reason, it is unclear that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention , as recited in claims 1-4, 7-10 and 13-14, including detecting any and all types of components in all types of samples that may be reacted with an enzyme to produce hydrogen peroxide. 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 appl icant regards as his invention. Claims 1-4, 6 and 13 -14 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. On line 2 of claim 1, the phrase “the reaction” lacks antecedent basis. Claim 1 is indefinite since it is not clear how the color change detected in step (c) of the method is used to quantify the hydrogen peroxide produced from the component to be measured in the sample. Is the color change compared to a set of reference colors that each correlate to an amount of hydrogen peroxide produced from different known amounts of the component to be measured in the specimen? Claim 13 is indefinite since it is not clear whether the at least one compound having general formula (1) which is phenylglyoxal in the first reagent of the kit is the same as the “at least one compound” recited on lines 2-3 of claim 13. Claim 13 is also indefinite since it recites on lines 1-3 that the kit comprises an enzyme that acts on a component to be measured to produce hydrogen peroxide, a coloring agent, a peroxidase, and at least one compound, and then recites that the kit comprises a first reagent comprising at least one compound and a second reagent comprising the enzyme on lines 4-10 . It is unclear whether the coloring agent and the peroxidase are located in additional, separate reagents in the kit, or whether the coloring agent and the peroxidase can be included in the first reagent or the second reagent. Claim 13 is confusing and unclear as to which reagents in the kit include which components. On line 2 of claim 14, the phrase “the influence” lacks antecedent basis. Claim 14 is indefinite since it is not clear when the specimen is contacted with the compound (i.e. phenylglyoxal) in the method. It is also not clear how the hydrogen peroxide is produced or derived from the component to be measured in the method. Claim 14 fails to specifically recite ordered steps of the method such as contacting a specimen with a reagent (i.e. an enzyme) to produce hydrogen peroxide from a component to be measured in the specimen in the presence of the compound (i.e. phenylglyoxal), reacting the produced hydrogen peroxide with a coloring agent in the presence of peroxidase to quantify an amount of the hydrogen peroxide, and correlating the amount of the hydrogen peroxide with an amount of the component to be measured. Inventorship 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 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. Claim(s) 1-4, 7-10 and 13-14 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Russell et al (WO 01/32916, submitted in the IDS filed on October 31, 2024) . With regards to claim 1, Russell et al teach of a method for measuring a component to be measured in a specimen by quantifying hydrogen peroxide produced through reaction of the component to be measured with an enzyme, wherein the component to be measured comprises one or more lysophospholipids in a sample of bodily fluid taken from a test subject. The method comprises producing hydrogen peroxide by contacting a sample of bodily fluid with enzymes comprising at least one lipase enzyme such as lysoph o spholipase and at least one cycling enzyme such as glycerol-3-phosphate oxidase in the presence of an additional compound for inhibiting the production or hydrolysis of lysophospholipids in the sample, wherein the additional compound can comprise phenylglyoxal , which has the formula (1) as recited in instant claim 1, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. The method then comprises reacting the produced hydrogen peroxide with peroxidase and a coloring agent comprising a chromogenic peroxidase substrate, and detecting a resulting color change as an indication of an amount of hydrogen peroxide produced from the component to be measured (i.e. lysophospholipids ). See the abstract, pages 6-8 and the claims in Russel et al. With regards to claim s 2-4 , Russell et al teach that in addition to the enzymes for producing hydrogen peroxide from the sample, a compound is also added to the sample for inhibiting the production or hydrolysis of lysophospholipids , wherein this additional compound can comprise phenylglyoxal, which has the formula (1) as recited in instant claim 1, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. See the abstract, pages 6-8 and the claims in Russel et al. With regards to claim 7 , Russell et al teach of a measurement reagent comprising an enzyme that acts on a component to be measured in a sample to produce hydrogen peroxide, wherein the component to be measured is one or more lysophospholipids in a sample of bodily fluid taken from a test subject and the enzyme comprises at least one lipase enzyme such as lysophospholipase and at least one cycling enzyme such as glycerol-3-phosphate oxidase, a coloring agent comprising a chromogenic peroxidase substrate, peroxidase and at least one compound having the same general formula as formula (1) recited in instant claim 7, wherein the at least one compound comprises phenylglyoxal, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. See the abstract, pages 6-8 and the claims in Russel et al. With regards to claims 8-10 , Russell et al teach that in addition to the enzymes for producing hydrogen peroxide from the sample, a compound is also added to the sample for inhibiting the production or hydrolysis of lysophospholipids , wherein this additional compound can comprise phenylglyoxal, which has the formula (1) as recited in instant claim 7, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. See the abstract, pages 6-8 and the claims in Russel et al. With regards to claim 13 , Russell et al teach of a measurement reagent kit comprising an enzyme that acts on a component to be measured in a sample to produce hydrogen peroxide, wherein the component to be measured is one or more lysophospholipids in a sample of bodily fluid taken from a test subject and the enzyme comprises at least one lipase enzyme such as lysophospholipase and at least one cycling enzyme such as glycerol-3-phosphate oxidase, a coloring agent comprising a chromogenic peroxidase substrate, peroxidase and at least one compound having the same general formula as formula (1) recited in instant claim 13, wherein the at least one compound comprises phenylglyoxal, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. See the abstract, pages 6-8 and claims 1-11 in Russel et al which specifically recite a diagnostic kit. With regards to claim 14 , Russell et al teach of a method for measuring a component to be measured in a specimen by quantifying hydrogen peroxide produced through reaction of the component to be measured with an enzyme, wherein the component to be measured comprises one or more lysophospholipids in a sample of bodily fluid taken from a test subject. The method comprises producing hydrogen peroxide by contacting a sample of bodily fluid with enzymes comprising at least one lipase enzyme such as lysophospholipase and at least one cycling enzyme such as glycerol-3-phosphate oxidase in the presence of an additional compound for inhibiting the production or hydrolysis of lysophospholipids in the sample, wherein the additional compound can comprise phenylglyoxal, which has the formula (1) as recited in instant claim 1, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen. The method then comprises reacting the produced hydrogen peroxide with peroxidase and a coloring agent comprising a chromogenic peroxidase substrate, and detecting a resulting color change as an indication of an amount of hydrogen peroxide produced from the component to be measured (i.e. lysophospholipids ). Although Russell et al do not specifically teach that the additional compound comprising phenylglyoxal added to the sample in the method serves to also circumvent the influence of hydrogen peroxide derived from a component other than the component to be measured in the sample , since the phenylglyoxal compound added to the sample in the method taught by Russell et al has the same formula as formula (1) recited in instant claim 14, wherein R1 is an aryl group (i.e. phenyl) and R2 is hydrogen, it would inherently also perform the same function as the compound having formula (1) in claim 14 of circumventing the influence of hydrogen peroxide derived from a component other than the component to be measured in the sample. See the abstract, pages 6-8 and the claims in Russel et al. Allowable Subject Matter Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims since the closest prior art of record to Russell et al (WO 01/32916, submitted in the IDS filed on October 31, 2024) fails to teach or fairly suggest a method and a reagent for measuring HbA1c in a sample comprising reacting the sample with an enzyme and a compound comprising phenylglyoxal in order to produce hydrogen peroxide from the reaction between the enzyme and the HbA1c while circumventing an influence of hydrogen peroxide derived from components in the sample other than HbA1c, reacting the produced hydrogen peroxide derived from the HbA1c with a coloring agent in the presence of peroxidase, and detecting a color change as an indication of the amount of the hydrogen peroxide derived from the HbA1c in the sample. Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims for the same reasons as set forth above. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please make note of: Murakami et al (US 2013/0171676) who teach of a method for measuring glycated hemoglobin; Sakata et al (US 5,384,248) who teach of a method for measuring an analyte with an oxidase and an oxidizable color reagent; Yonehara et al (US 2005/0042709) who teach of a method of quantifying glycated hemoglobin in a sample using a redox reaction; and Hirai (US 2007/0134754) who teach of a method for measuring a glycated amine analyte in a sample by initially adding a fructosyl amino acid oxidase (FAOD) to the sample to act on a non-analyte glycated amine that is present in the sample and different from the glycated amine as the analyte in order to remove an influence of the non-analyte glycated amine. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266 . The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander , can be reached at telephone number 571-272-1254 . 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/ InterviewPractice . /MAUREEN WALLENHORST/ Primary Examiner, Art Unit 1797 December 1 8 , 2025