Prosecution Insights
Last updated: April 19, 2026
Application No. 18/007,689

METHOD AND KIT FOR QUANTIFICATION OF LIPOPROTEIN CHOLESTEROL

Non-Final OA §102§103§112§DP
Filed
Dec 01, 2022
Examiner
XU, QING
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Denka Company Limited
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
3y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
142 granted / 282 resolved
-9.6% vs TC avg
Strong +55% interview lift
Without
With
+54.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
34 currently pending
Career history
316
Total Applications
across all art units

Statute-Specific Performance

§101
6.5%
-33.5% vs TC avg
§103
32.5%
-7.5% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
29.9%
-10.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 282 resolved cases

Office Action

§102 §103 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Status of the Application Applicant’s arguments and amendment submitted on 12/08/2025 are acknowledged. Claims 1, 3-14, 18, 23-27, 29, and 30 are pending. Claims 14, 18, and 27 are amended. Claims 2, 15-17, 19-22, and 28 are canceled. Claims 29 and 30 are new. Claims 1, 3-13, 18, 25-26, and 29-30 are withdrawn. Claims 14, 23-24, and 27 have been examined on the merits. Applicant’s election without traverse of Group II, claims 14, 18, 23-24, 27, and 29-30, drawn to a method of quantifying lipoprotein cholesterol, in the response filed on 12/08/2025, is acknowledged. Claims 1, 3-13, and 25-26 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant’s election with traverse of the species: a combination of using the peroxidase and hydrogen donor in the first step and using the coupler and iron complex in the second step, in response to the species requirement set forth in the prior office action is acknowledged. Claims 18 and 29-30 are withdrawn from further consideration by the Examiner, Per 37 CFR 1.142(b), as being drawn to a non-elected species Applicant’s traverse is on the grounds that both claims 14 and 18 involve the use of a coupler and iron complex for suppressing spontaneous color development in the assay. Applicant’s arguments have been fully considered but are not deemed persuasive. Examiner would like to point out that the steps of using the coupler and iron complex in the claim 14 are distinct from the steps of using the coupler and iron complex in the claim 18. Specifically, the method of the claim 14 requires a first step of using peroxidase for acting on hydrogen peroxide and then a second step of adding the coupler and iron complex for quantifying cholesterol. On the other hand, the method of the claim 18 does not require such steps. Rather, it requires a first step of using the coupler and iron complex before carrying out a second step of using peroxidase for acting on hydrogen peroxide. Therefore, the claim 14 and the claim 18 do not overlap in scope and they have different features which require different search in the patent and non-patent literature. The requirement is deemed proper and therefore is made FINAL. Priority This application, U.S. Application number 18/007689, is a national stage entry of International Application Number PCT/JP2021/020923, filed on 06/02/2021, which claims the foreign priority under 35 U.S.C. 119(a)-(d) to JP 2020-096248 filed on 06/02/2020. It is noted that although a certified copy of the foreign priority application is filed, no English language translation is provided for this certified priority document. According to MPEP 706.02(b)(1)(C), the filing date of the priority document is not perfected unless applicant has filed a certified priority document in the application and an English language translation when the document is not in English (see 37 CFR 1.55(g)). Therefore, the priority date 06/02/2021of foreign priority application is not granted to the instant application. The filing date 06/02/2021 of the International Application has been used for prior art purposes for the instant claims. Specification The abstract of the specification is objected to, because it exceed 150 words. Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. Appropriate correction is required. Information Disclosure Statement The information disclosure statements (IDS) submitted on 12/01/2022 and 12/18/2023 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97., and have been considered by the examiner. Drawings The drawings submitted on 12/01/2022 have been reviewed and are accepted by the Examiner for examination purposes. Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph 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 14, 23-24, and 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 pre-AIA the applicant regards as the invention. Claim 14 is indefinite due to the recitations of “the analyte to the outside of the reaction system”, “the analyte lipoprotein cholesterol”, “the coupler”, “the iron complex”, “the peroxidase”, “the hydrogen donor”, and “the surfactant”. There are no sufficient antecedent basis for these limitations in the claim. It is noted that there are multiple different types of lipoprotein cholesterols or cholesterol analytes (e.g. LDL, HDL and VLDL), couplers, iron complexes, peroxidase enzymes, hydrogen donors, and surfactants. It is unclear which specific cholesterol, analyte, coupler, iron complex, peroxidase, hydrogen donor, and surfactant these recited terms refer to. Furthermore, the claim recites the limitation “in either the step (1) or (2), at least the coupler, the iron complex, the peroxidase, the hydrogen donor, and the surfactant are used”, which requires that coupler, iron complex, peroxidase, hydrogen donor, and surfactant are used together in either step (1) or step (2). However, this limitation is conflicted with the additional limitation “the coupler and the hydrogen donor are not used in the same step” further recited in the claim. It is unclear how the step (1) or (2) can use all of coupler, iron complex, peroxidase, and hydrogen donor, and surfactant together, while the coupler and hydrogen donor are not used in the same step. For the purpose of examination, these two limitations are interpreted as two alternative limitations for defining the claimed method (i.e. the claim does not require meeting these two limitations at the same time). Furthermore, the claim is indefinite because of the term “coupler” recited in the claim. This term is not defined in the specification. In the broadest and reasonable interpretation, a hydrogen donor can be considered as a coupler because the hydrogen donor is coupled with peroxidase and reacts with hydrogen peroxide for producing a quinone product (as evidenced by Satoh et al. described below in the 103 rejection). However, the claim recites the limitation of the coupler and hydrogen donor are not used in the same step, implying they are not the same compound. It is unclear what specific compound can be considered as a coupler. Applicant is required to clarify the metes and boundary of the term “coupler”. Claim 23 is indefinite due to the recitations of “the analyte” and “the analyte lipoproteins”. There is no sufficient antecedent basis for these limitations in the claim, as indicated above. Claim 24 is indefinite due to the recitation of “the analyte lipoprotein cholesterol”. There is no sufficient antecedent basis for this limitation in the claim, as indicated above. Claim 27 is indefinite due to the recitation of “the use of the catalase”. There is no sufficient antecedent basis for this limitation in the claim, because the claim does not previously define any specific catalase or any use of this enzyme. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 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 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. Claims 14, 23-24, and 27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Itoh et al. (WO 2021/049518, published on Mar. 18, 2021, effective filing date: 9/10/2019, cited in IDS). Examiner notes that Itoh et al. (EP 4029948, 2022, cited in IDS) is an English version equivalent to Itoh et al. (WO 2021/049518). Accordingly, all citations in this rejection are made to Itoh et al. (EP 4029948). Itoh et al. teach a method of qualifying cholesterol of small, dense LDL lipoprotein in a sample in two steps, comprising: (1) a first step of guiding cholesterol in lipoprotein other than small, dense LDL to the outside of the reaction system in the presence of cholesterol esterase activity (cholesterol esterase) and cholesterol oxidase activity (cholesterol oxidase); and (2) a second step of quantifying cholesterol in lipoprotein remaining in the sample after the first step; wherein the peroxidase activity (peroxidase) and the electron donor are used in the first step, and the coupler and the iron complex are used in the second step; wherein the first step further comprises using catalase activity (catalase); wherein a surfactant acting on lipoproteins other than the small, dense LDL is used in the first step, and a surfactant acting at least on the small, dense LDL is further used in the second step; and wherein the electron donor is N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline (TOOS), N-ethyl-N-(2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline (MAOS), N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), N-(2-hydroxy-3-sulfopropyl) -3,5-dimethoxyaniline (HDAOS), or N-(3-sulfopropyl) aniline (HALPS), N-(3-sulfopropyl)-3-methoxy-5-aniline (HMMPS) (Claims 13, 18, 21, and 22, para 0036). It is noted that the electron donor (i.e. TOOS, MAOS, TOPS, HDAOS, HALPS, HMMPS) of Itoh et al. meets the requirement of the hydrogen donor recited in the instant claim 14, as evidenced by the specification of the instant application, which discloses the hydrogen donor is TOOS, MAOS, TOPS, HDAOS, HALPS, or HMMPS (see para 0036 in page 14 of the specification). Therefore, in view of the teachings of Itoh et al., the method of Claims 14, 23-24, and 27 is anticipated by the method of Itoh et al. 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 of this title, 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. 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 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. Claims 14, 23-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh et al. (WO 2019/189642, published on 10/3/2019, effective filing date: 3/28/2018, cited in IDS) in view of Arai et al. (US Patent No. 5004685, 1991). Satoh et al. (US 2021/0011036, published on Jan. 14, 2021, effective filing date: 3/28/2018, cited in IDS) is an English version equivalent to Satoh et al. (WO 2019/189642). Accordingly, the claims are also rejected over Satoh et al. (US 2021/0011036) in view of Arai et al. All citations in this rejection are made to Satoh et al. (US 2021/0011036). Satoh et al. teach a method for quantification of lipoprotein cholesterol in a sample (paras 0029-0035), comprising: Step (1) for eliminating cholesterol in the lipoproteins other than the lipoprotein cholesterol to be quantified, and a subsequent Step (2) for quantifying the lipoprotein cholesterol remaining after the Step (1); wherein in the Step (1), cholesterol in the lipoproteins other than the lipoprotein cholesterol to be quantified is selectively eliminated/decomposed such that the decomposed product is not detected in the subsequent Step (2); wherein the process of selectively eliminating cholesterol contained in the lipoproteins other than the lipoprotein to be quantified includes a process in which cholesterol oxidase and cholesterol esterase are allowed to act on the sample, and then the resulting hydrogen peroxide is removed by utilizing the reaction of peroxidase, in which, a hydrogen donor compound that reacts with hydrogen peroxide to produce a colorless quinone is converted to the colorless quinone; wherein in the Step (2) cholesterol oxidase and cholesterol esterase are allowed to act on the cholesterol remaining after the Step (1), and the resulting hydrogen peroxide is converted to a quinone pigment by using peroxidase, a hydrogen donor, and a hydrogen acceptor, followed by quantifying the pigment by measurement of the absorbance; and wherein suitable surfactant(s) are used in the Step (1) and Step (2) for promoting the enzyme reaction in each step, the step (1) involves the use of a surfactant suitable for eliminating cholesterol in the lipoproteins other than the lipoprotein to be quantified, and the step (2) involves the use of a surfactant that reacts with all lipoproteins remaining after the step (1) (paras 0045, 0048, and 0034, 0050, 0059/lines 1-3, 0060/lines 1-2). Satoh et al. further teach that the hydrogen acceptor is 4-aminoantipyrine (paras 0054, and 0060/line 4). Overall, in the method of Satoh et al., the Step (1) involves the use of cholesterol oxidase, cholesterol esterase, peroxidase, a hydrogen donor, and surfactant; and the Step (2) involves the use of a hydrogen donor, a hydrogen acceptor, and surfactant along with enzymes including peroxidase. It is noted that either the hydrogen donor or the hydrogen acceptor in the Step (2) can be considered as a “coupler” recited in the claim 14 since they are coupled with peroxidase and react with hydrogen peroxide for producing a quinone product. The method of Satoh et al. differs from the method of Claim 14 in that Satoh et al. do not teach using an iron complex in the Step (2). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modifying the method of Satoh et al. by using an iron complex, specifically a ferrocyanide compound, in the Step (2) for measuring an amount of hydrogen peroxide producing from the lipoprotein cholesterol to be quantified, thus for quantifying the lipoprotein cholesterol, because it is well known in the art that a ferrocyanide iron complex compound is effective at converting hydrogen peroxide and a chromogen (hydrogen acceptor) to a pigment product for measuring a lipoprotein cholesterol in a sample. In support, Arai et al. teach a process for determining/measuring an analyte cholesterol in a sample by measuring an amount of hydrogen peroxide produced from the interaction between the analyte cholesterol and a cholesterol oxidase, wherein the process comprises using a combination of cholesterol oxidase, hydrogen peroxide (POD), a ferrocyanide compound (iron complex), and a colorless chromogen to act on the analyte cholesterol, which generates a color/pigment product, causing an optically detectable change to be used for measuring the cholesterol (see the reaction formula in col. 2/lines 15-33; col. 3/lines 21-32; col. 4/lines 46-56; col. 8/lines 16-17, 20, and 37-38; Claim 1), wherein the chromogen is a coupling-type chromogen, preferably 4-aminoantipyrine, which is coupled with an aniline-type compound/coupler (col. 8/lines 48-49; col. 9/lines 1-2, 11-12, and 15-17) (Note: the chromogen 4-aminoantipyrine used in the method of Arai et al. is the same compound as the hydrogen acceptor 4-aminoantipyrine in the method of Satoh et al.). Regarding the claim 24, Satoh et al. teach that the lipoprotein cholesterol is a cholesterol of VLDL, LDL, HDL or VLDL remnant (page 3: paras 0032, and 0037/last 5 lines). Regarding the claim 27, Satoh et al. teach further including catalase in the Step (1) (paras 0059/lines 4 and 6). Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention. 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 14, 23-24, and 27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9-11, 13-14, and 16-28 of copending Application No. 18/007690 in view of Higuchi et al. (US 2013/0171674, 2013, cited in IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims of the ‘690 application are directed in part to a method of quantifying cholesterol in a lipoprotein other than small dense low density lipoprotein (sd LDL) in a sample, comprising: step (a) causing a first reagent composition having a cholesterol esterase activity (cholesterol esterase) and a cholesterol oxidase activity (cholesterol oxidase) to act on the sample, wherein the first reagent composition further comprises a surfactant; step (b) causing a second reagent composition to act on the sample to quantify cholesterol in a remaining lipoprotein after the step (a); wherein: (i) the first reagent composition satisfies one or two of the conditions: containing a coupler, containing an iron complex, and having peroxidase activity, and (ii) the second reagent composition does not satisfy the one or two of the conditions, but all other conditions; wherein the first reagent composition comprises at least one of peroxidase activity (peroxidase) and catalase activity (catalase); wherein the second reagent composition contains a surfactant; wherein the lipoprotein contains LDL cholesterol, HDL cholesterol, HDL3 cholesterol, remnant cholesterol, or apoE-containing HDL cholesterol; wherein the first reagent composition comprises both cholesterol esterase activity (cholesterol esterase) and cholesterol oxidase activity (cholesterol oxidase), and further comprises peroxidase activity (peroxidase); wherein the first reagent composition comprises the cholesterol esterase activity (cholesterol esterase), the cholesterol oxidase activity (cholesterol oxidase), catalase activity (catalase), and peroxidase activity (peroxidase); wherein the first reagent composition further comprises a protein having no enzymatic activity; wherein a measurement target is the HDL or the HDL3; and wherein a measurement target is the sd LDL or the apoE-containing HDL; wherein the coupler is one or more selected from 4-aminoantipyrine, an aminoantipyrine, vanillindiaminesulfonic acid, methylbenzthiazolinone hydrazone, and sulfonated methylbenzthiazolinone hydrazone. The claimed method of the ‘690 application differs from the instantly claimed method in that the claims of the ‘690 application are silent about whether a hydrogen donor is included in the first reagent composition used in the step (a) (i.e. the first step). However, it would have been obvious to include a hydrogen donor in the first reagent composition in the method of the ‘690 application for quantifying cholesterol in a lipoprotein, because it is a common practice in the art to include a hydrogen donor along with peroxidase in a reagent composition for acting on hydrogen peroxide generated from the interaction between the cholesterol and cholesterol oxidase. In support, Higuchi et al. teach a method for quantifying cholesterol in HDL3 lipoprotein in a sample, wherein the lipoprotein cholesterol (other than LDL3) is eliminated in a first step such that the cholesterol does not affect the reaction for measurement of cholesterol in a later step; and wherein cholesterol esterase and cholesterol oxidase are allowed to act on the lipoprotein cholesterol (other than LDL3) to generate hydrogen peroxide, which is then reacted with a hydrogen donor in the presence of peroxidase and converted to a colorless quinone (paras 0024, 0028, 0029/lines 1-7 and 9-11). Therefore, in view of the teachings of the cited prior art, the method of Claims 14, 23-24, and 27 of the instant application is deemed obvious over the method of Claims 9-11, 13-14, and 16-28 of the copending Application No. 18/007690. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. Claims 14, 23-24, and 27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 13, 18, and 21 of copending Application No. 17/641689. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims of the ‘689 application are directed in part to a method of quantifying cholesterol in small, dense LDL in a sample obtained from a subject in two steps, comprising: (1) a first step of leading cholesterol in lipoproteins other than small, dense LDL to outside of a reaction system in the presence of cholesterol esterase activity, cholesterol oxidase activity, and a surfactant that acts on lipoproteins other than small, dense LDL; and (2) a second step of quantifying cholesterol in lipoproteins remaining after the first step in the presence of a surfactant that acts on at least small, dense LDL, wherein,(i) in either the step (1) or (2), at least a coupler, an iron complex, peroxidase, catalase, electron donor and a surfactant are used; (ii) the coupler and the electron donor are not used simultaneously in the same step; (iii) the coupler and iron complex are used simultaneously in one of the step (1) or step (2) and the peroxidase is used in the other step; and (iv) the coupler, iron complex and peroxidase are not used simultaneously in the same step; wherein the first step involves the use of the peroxidase and an electron donor (in a first reagent), and the second step involves the use of the coupler and the iron complex (in a second reagent); and wherein the first step further involves the use of catalase (in a first reagent). Regarding the hydrogen donor used in the first step of the instant claim 14, the electron donor used in the first step of the ‘689 application appears to be an alternative term used for representing the hydrogen donor, as evidenced by the specification of the ‘689 application (see para 0030 in pages 14-15) and the specification of the instant application (see para 0036 in page 14), which disclose the same chemical compounds (i.e. TOOS, MAOS, TOPS, HDAOS, HALPS, and HMMPS) as the electron donor and the hydrogen donor, respectively. Therefore, the method of Claims 14, 23-24, and 27 of the instant application is deemed obvious over the method of over claims 13, 18, and 21 of copending Application No. 17/641689. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. Claims 14, 23-24, and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 7-12 of US Patent No. 12209270 in view of Higuchi et al. (US 2013/0171674, 2013, cited in IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims of the ‘270 patent are directed in part to a method of quantifying small dense LDL cholesterol (sdLDL-C) in a sample, comprising: (a) allowing a first reagent composition having cholesterol esterase activity and cholesterol oxidase activity to act on the sample; and (b) allowing a second reagent composition for quantifying the sdLDL-C to act to quantify cholesterol in a remaining lipoprotein, wherein the first reagent composition satisfies one or two conditions of Conditions 1 to 3, and wherein the second reagent composition does not satisfy the one or two conditions of Conditions 1 to 3 and satisfies all other conditions, wherein Condition 1 comprises a coupler, wherein Condition 2 comprises an iron complex; and wherein Condition 3 possesses a peroxidase activity; wherein the first reagent composition further has catalase activity; wherein the first reagent composition contains a surfactant that acts on lipoproteins other than the sdLDL; and wherein the second reagent composition contains a surfactant that acts on the sdLDL. The claimed method of the ‘270 patent differs from the instantly claimed method in that the claims of the ‘270 patent are silent about whether a hydrogen donor is included in the first reagent composition used in the step (a) (i.e. the first step). However, it would have been obvious to include a hydrogen donor in the first reagent composition in the method of the ‘270 patent for quantifying the sdLDL cholesterol in a sample, because it is a common practice in the art to include a hydrogen donor along with peroxidase in a reagent composition for acting on hydrogen peroxide generated from the interaction between the cholesterol and cholesterol oxidase, as supported by Higuchi et al. (described above) Therefore, in view of the teachings of the cited prior art, the method of Claims 14, 23-24, and 27 of the instant application is deemed obvious over the method of claims 7-12 of US Patent No. 12209270. Conclusion No claim is in condition for allowance. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PMR) 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). Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600. /Qing Xu/ Patent Examiner Art Unit 1656
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Prosecution Timeline

Dec 01, 2022
Application Filed
Feb 07, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
99%
With Interview (+54.8%)
3y 10m
Median Time to Grant
Low
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