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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on June 5, 2026 has been entered.
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.
Claims 1, 6, 9, 11-13, 17-18 and 21 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.
Step (2)(i) of the method recited in claim 1 which recites “(i) at least a coupler, an iron complex, peroxidase, catalase, electron donor and a surfactant are comprised in either the first reagent composition or second reagent composition” is indefinite since this limitation requires that the coupler, the iron complex, the peroxidase, the catalase, the electron donor and the surfactant are used together in either the first reagent composition or the second reagent composition. However, this conflicts with each of step (2)(ii) in claim 1 which recites that the coupler and the electron donor are not present in the same reagent composition, step (2)(iii) in claim 1 which recites that the coupler and the iron complex are present in one of the first reagent composition or the second reagent composition, and the peroxidase is present in the other of the first reagent composition or second reagent composition, and step (2)(iv) in claim 1 which recites that the coupler, iron complex and peroxidase are not present in the same reagent composition. It is unclear how all of a coupler, an iron complex, peroxidase, catalase, an electron donor and a surfactant are comprised in either the first reagent composition or second reagent composition while at the same time, either the coupler and the electron donor are not present in the same reagent composition, the coupler and the iron complex are present in one of the first reagent composition or the second reagent composition, and the peroxidase is present in the other of the first reagent composition or second reagent composition, or the coupler, the iron complex and peroxidase are not present in the same reagent composition. See this same problem on lines 9-14 of claim 13 where it recites “(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”.
Dependent claims 6, 9, 11-12, 17-18 and 21 are rejected under 35 USC 112(b) for the same reasons as set forth above in view of their dependency on either claim 1 or claim 13.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 9, 11-13, 17-18 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 10, 12-14, 18, 23, 25, 27 and 29 of copending Application No. 18/007,689 in view of Itoh et al (US 2010/0255516, submitted in the IDS filed on March 9, 2022). It is noted that application serial no. 18/007,689 has an earlier effective filing date of June 2, 2020 than the effective filing date of the instant application, which is September 9, 2020, since an English-language translation of the foreign priority document was filed in application serial no. 18/007,689, whereas no English-language translation of the foreign priority document in the instant application has been filed. Therefore, application serial no. 18/007,689 constitutes the earlier filed application in this rejection based on the ground of nonstatutory double patenting
Claims 1, 5-6, 10 and 12-13 in application no. 18/007,689 recite a kit for the quantification of cholesterol in a sample obtained from a subject comprising a first reagent composition comprising cholesterol esterase, cholesterol oxidase and a surfactant for acting on lipoproteins other than an analyte lipoprotein to be measured, wherein the first reagent composition leads lipoprotein cholesterol other that the analyte to the outside of a reaction system (see claims 1 and 10 in application no. 18/007,689 and instant claim 1), and a second reagent composition for quantifying the analyte lipoprotein cholesterol comprising a surfactant that acts on at least the analyte lipoprotein (see claims 1 and 10 in application 18/007,689, and instant claim 1), wherein the first reagent composition or the second reagent composition comprises at least a coupler, an iron complex, peroxidase, a hydrogen/electron donor, and a surfactant, provided that the coupler and the hydrogen/electron donor are not allowed to be present in the same reagent composition (see claims 1 and 5-6 in application 18/007,689 and instant claim 1), and the coupler, the iron complex, and peroxidase are not allowed to be present together in either of the first reagent composition or the second reagent composition (see claims 1 and 5-6 in application no. 18/007,689 and instant claim 1). Claims 12-13 of application no. 18/007,689 also recite that the surfactant in the first reagent composition comprises a polyoxyethylene polycyclic phenyl ether derivative such as polyoxyethylene benzyl phenyl ether, which corresponds to instant claims 11-12. Claims 14, 18, 23, 25, 27 and 29 of application serial no. 18/007,689 recite a method for quantifying lipoprotein cholesterol in a sample comprising a first step of leading lipoprotein cholesterol other than an analyte lipoprotein to an outside of a reaction system in the presence of cholesterol esterase, cholesterol oxidase and a surfactant that acts on lipoproteins other than the analyte lipoprotein (see claims 14, 18, 23 and 29 in application no. 18/007,689 and instant claim 13), and a second step of quantifying the analyte lipoprotein cholesterol remaining after the first step, wherein in the two steps of the method for quantification, collectively, a coupler, an iron complex, a peroxidase, a hydrogen/electron donor, and a surfactant are used, the coupler and the hydrogen/electron donor are not used in the same step, and the first step comprises the use of the peroxidase and the hydrogen/electron donor and the second step comprises the use of the coupler and the iron complex (see claim 14 in application no. 18/007,689 and instant claims 13 and 18), or wherein the first step involves the use of the coupler and the iron complex and the second step involves the use of the hydrogen/electron donor and the peroxidase (see claim 18 of application no. 18/007,689 and instant claims 13 and 17). Claims 25 and 27 of application serial no. 18/007,689 also recite that the first composition in the kit and the first step of the method for quantifying lipoprotein cholesterol in an analyte lipoprotein comprises catalase, which corresponds to instant claims 1, 9, 13, 17 and 21.
Claims 1, 5-6, 10, 12-14, 18, 23, 25, 27 and 29 of copending Application No. 18/007,689 fail to recite that the analyte lipoprotein measured using the kit and in the method comprises small, dense LDL, and fail to teach that the first reagent composition in the kit and the first step of the method where lipoproteins other than small, dense LDL are led to the outside of a reaction system comprises sphingomyelinase.
Itoh et al teach of a method and a kit for quantitatively determining small, dense LDL cholesterol in a sample. The kit comprises a first reagent composition for eliminating cholesterol in LDL and other lipoproteins other than small, dense LDL in a sample, and a second reagent composition for the measurement of small, dense LDL in the sample. The first reagent composition comprises cholesterol esterase (i.e. cholesterol esterase activity), cholesterol oxidase (i.e. cholesterol oxidase activity), catalase, sphingomyelinase (i.e. sphingomyelinase activity), and a surfactant that acts on lipoproteins other than small, dense LDL, wherein the surfactant comprises a polyoxyethylene polycyclic phenyl ether, specifically polyoxyethylene distyrenated phenyl ether. See Reagent composition AB in Examples 8 and 10 in Itoh et al. The second reagent composition in the kit comprises a coupler (i.e. 4-aminoantipyridine), peroxidase and a surfactant that acts on at least small, dense LDL, wherein the surfactant comprises polyoxyethylenenonyl phenyl ether. See Reagent composition C in Examples 8 and 10 in Itoh et al. The coupler and peroxidase are in the second reagent composition of the kit which are not present in the first composition. The method taught by Itoh et al comprises a first step of leading cholesterol in lipoproteins other than small, dense LDL to the outside of a reaction system in the presence of cholesterol esterase (i.e. cholesterol esterase activity), cholesterol oxidase (i.e. cholesterol oxidase activity), catalase, sphingomyelinase (i.e. sphingomyelinase activity) and a surfactant that acts on lipoproteins other than small, dense LDL, wherein the surfactant comprises a polyoxyethylene polycyclic phenyl ether, specifically polyoxyethylene distyrenated phenyl ether. The method then comprises a second step of quantifying cholesterol in lipoproteins remaining after the first step (i.e. the small, dense LDL) using the second reagent composition comprising a coupler (i.e. 4-aminoantipyridine), peroxidase and a surfactant that acts on at least small, dense LDL, wherein the surfactant comprises polyoxyethylenenonyl phenyl ether. See Examples 8 and 10, and the claims in Itoh et al. Itoh et al teach that in the second step of the method comprising quantifying cholesterol in lipoproteins remaining after the first step (i.e. the small, dense LDL), the cholesterol in the small, dense LDL is quantified by using the enzymes cholesterol esterase and cholesterol oxidase which react with cholesterol in small, dense LDL to produce hydrogen peroxide. A dye is then generated from the formed hydrogen peroxide by a coupling reaction with a hydrogen donor and a hydrogen receptor in the presence of peroxidase. The cholesterol in small, dense LDL is then quantitatively determined through measurement of the dye at a wavelength between 400 and 700 nm. See paragraph 0050 in Itoh et al. Itoh et al also teach that the specific reagents and chemicals to be used in the method for determining small, dense LD can be divided into a plurality of reagent compositions in view of their stability, including the surfactant that reacts with lipoproteins other than small, dense LDL, the enzymes for cholesterol measurement such as cholesterol esterase and cholesterol oxidase, the catalase that degrades the formed hydrogen peroxide, the peroxidase for the formation of a dye from hydrogen peroxide via a coupling reaction, the hydrogen donor and the hydrogen acceptor used in the reaction with hydrogen peroxide and peroxidase to form a dye, and a buffer. See paragraph 0060 in Itoh et al, and overall, see paragraphs 0008, 0023, 0050, 0052, 0060-0061, 0066, 0093-0094 and 0100-0101, and the claims in Itoh et al.
Based upon the combination of claims 1, 5-6, 10, 12-14, 18, 23, 25, 27 and 29 of copending Application No. 18/007,689 and Itoh et al, it would have been obvious to one of ordinary skill in the art to use the kit and method recited in the claims of application serial no. 18/007,689 to detect cholesterol in small, dense LDL as the analyte lipoprotein, and to include sphingomyelinase in the first reagent composition of the kit so that the first step of the method recited in the claims of application serial no. 18/007,689 includes a sphingomyelinase activity to lead cholesterol in lipoproteins other than small, dense LDL to the outside of a reaction system because Itoh et al teach that small, dense lipoprotein (LDL) cholesterol is a known type of analyte lipoprotein cholesterol to measure in a sample since this type of lipoprotein cholesterol is several fold more atherogenic than normal LDL and an increase of small, dense LDL in a subject is a major risk factor for arteriosclerosis (see paragraph 0002 in Itoh et al), and also teach that sphingomyelinase in a first reagent of a kit or used in a first step of a method for determining small, dense LDL in a sample allows lipoprotein cholesterol in LDL other than small, dense LDL to be efficiently eliminated (see Examples 8 and 10, and claims 1-2 in Itoh et al).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 11, 2026
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