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 Claims
The Amendment filed February 6, 2026 has been entered. Claims 1, 3, and 6-8 have been amended; claims 10-19 are new; and claims 5 and 9-11 have been cancelled. Claims 1-4, 6-8, and 10-19 are currently pending and examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have partially overcome claim objections previously set forth in the Non-Final Office Action mailed November 6, 2025.
New grounds of claim objection are necessitated by the amendment as outlined below.
New grounds of rejections for new claims 13-14 under 35 U.S.C. § 112(a) are necessitated by the amendment as outlined below.
All 35 U.S.C. § 103 rejections from the previous office action have been withdrawn in view of the amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2025 has been considered by the examiner.
Claim Objection
Claims 3, 7 and 10-19 are objected to because of the following informalities:
Claim 3: please add unit of molecular weight to “100 to 500”.
Claims 7 and 17-19: please amend “in a arrange from” to -- in a [[ar]]range from--.
Claims 10-19: Note that claims 9-11 are cancelled, thus new claims 10-19 should start from claim 12 instead of claim 10. Therefore, new claims 10-19 should be amended to new claims 12-21.
Claim 14: please amend “78.96 (s)” to --78.96 s [[(s)]] --.
Appropriate correction is required.
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 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.
Claim 13 recites “wherein a maximum absorbance of the [Symbol font/0x67]-globulin in the sample is equal to or greater than 6.31”, which is not supported by the specification. Tables 1-3 in the instant specification discloses a maximum absorbance variation of the [Symbol font/0x67]-globulin, but does not disclose that it is equal to or greater than 6.31. Furthermore, a maximum absorbance variation of the [Symbol font/0x67]-globulin in Tables 1-3 has a unit of mAbs/s. Therefore, claim 13 and its dependent claim 14 are new matters.
Claim 14 recites “wherein a peak detection time of the [Symbol font/0x67]-globulin in the sample is equal to or less than 78.96 (s)”, which is not supported by the specification. Tables 1-3 in the instant specification discloses a peak detection time of the [Symbol font/0x67]-globulin, but does not disclose that it is equal to or less than 78.96 (s). Therefore, claim 14 is a new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma (US20200011850A1), and in view of Onuma (US20140202858A1, hereinafter Onuma ’858).
Regarding claim 1, Onuma teaches a sample analysis method (an analysis method using a microchip for separating components such as albumin and γ-globulin contained in blood by capillary electrophoresis [abstract; para. 0036, 0041, 0046]), comprising:
separating components from a sample comprising the components, in an alkaline solution by capillary electrophoresis (the analysis method is used for analysis of components in a sample by capillary electrophoresis [para. 0041]; examples of a components which is contained in the blood and to be analyzed by the analysis method include hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen [para. 0046]; in the CE separation process , a voltage may be applied after the cathode is brought into contact with the second liquid stored in the sample reservoir 1, and the anode is brought into contact with the first liquid stored in the electrophoresis liquid reservoir 3, and in this case it is preferable to use an alkaline solution containing a cationic polymer for the first liquid and the second liquid [para. 0068]; the components in the sample contained in the second liquid [para. 0062]),
wherein the sample comprises a non-surfactant-type sulfobetaine (a diluent comprising 500 mM NDSB-201, and the sample was diluted 41-fold with the diluent to prepare a second liquid [para. 0105-0106]; note that the disclosed non-surfactant-type sulfobetaine of NDSB-201 is the same as that used in this instant application as evidenced by the first compound recited in instant claim 4), and
the alkaline solution comprises a cationic polymer (an alkaline solution containing a cationic polymer [para. 0068]).
Onuma teaches the components to be analyzed/separated by capillary electrophoresis include hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen [para. 0046], thus does not explicitly teach wherein the sample comprising albumin and γ-globulin to be separated.
Since the disclosed sample analysis method can be used to separate a sample containing components including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the sample analysis method that can separate components including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen to separate a sample containing albumin and γ globulin. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person of ordinary skill in the art. See MPEP § 2143(E).
Onuma teaches the sample was diluted with the diluent comprising 500 mM NDSB-201 to prepare the second liquid [para. 0105-0106], but does not explicitly teach wherein a content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample is from 0.1 mass % to 30 mass %.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A). Furthermore, “a content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample is from 0.1 mass % to 30 mass %” is rejected in view of Onuma ’858 in the following.
Onuma ’858 teaches a similar sample analysis method includes separating and/or detecting a substance to be analyzed in a sample through capillary electrophoresis (abstract), and further teaches the sample to be placed in the sample holding tank 4 can be prepared by diluting whole blood serving as a sample raw material with the solution for capillary electrophoresis of the present disclosure. The dilution ratio of the sample raw material is for example 1.2 to 100 times, 2 to 30 times, or 3 to 15 times. Further, in the case where the sample raw material contains ion components to such a degree as to influence resolution, the dilution ratio of the sample raw material is for example 2 to 1,000 times, 5 to 300 times, or 10 to 200 times [para. 0087]. Thus, the dilution ratio affects the capillary electrophoresis separation resolution.
Given the teachings of Onuma ’858 regarding the dilution ratio affects the capillary electrophoresis separation resolution, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the dilution ratio of the sample in Onuma would also affect the CE separation resolution. Thus, the dilution ratio and accordingly a content ratio of the non-surfactant-type sulfobetaine of NDSB-201 with respect to a total mass of the sample affects the CE separation resolution since the sample is diluted with the diluent comprising the NDSB-201.
As the CE separation resolution is a variable that can be modified, among others, by adjusting the content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample through adjusting the dilution ratio, the precise content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample being from 0.1 mass % to 30 mass% cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the dilution ratio and accordingly the content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample in Onuma to obtain the desired content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample in order to achieve the desired CE separation resolution. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 2, modified Onuma teaches the sample analysis method according to claim 1, and Onuma teaches wherein the non-surfactant-type sulfobetaine comprises a quaternary ammonium cation group (the disclosed NDSB-201 comprises a quaternary ammonium cation group).
Regarding claim 3, modified Onuma teaches the sample analysis method according to claim 1, and Onuma teaches wherein a molecular weight of the non-surfactant-type sulfobetaine is in a range from 100 to 500 (the molecular weight of the disclosed NDSB-201 is 201.24 g/mol, falls within the claimed range).
Regarding claim 4, modified Onuma teaches the sample analysis method according to claim 1, and Onuma teaches wherein the non-surfactant-type sulfobetaine comprises the following compound (the following compound corresponds to the disclosed NDSB-201):
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Regarding claims 10-12, modified Onuma teaches the sample analysis method according to claim 1, and Onuma is silent to: (1) wherein the content ratio of the non-surfactant-type sulfobetaine with respect to the total mass of the sample is in a range from 0.5 mass% to 20 mass% (of claim 10); (2) wherein the content ratio of the non-surfactant-type sulfobetaine with respect to the total mass of the sample is in a range from 1 mass% to 15 mass% (of claim 11); and (3) wherein the content ratio of the non-surfactant-type sulfobetaine with respect to the total mass of the sample is in a range from 1 mass% to 9 mass% (of claim 12).
As outlined in the rejection of claim 1 above, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A).
Furthermore, as the CE separation resolution is a variable that can be modified, among others, by adjusting the content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample through adjusting the dilution ratio, the precise content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample being in a range from 0.5 mass % to 20 mass% (claim 10), in a range from 1 mass % to 15 mass% (claim 11), or in a range from 1 mass % to 9 mass% (claim 12) cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the dilution ratio and accordingly the content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample in modified Onuma to obtain the desired content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample in order to achieve the desired CE separation resolution. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 13, modified Onuma teaches the sample analysis method according to claim 1, and the limitation “wherein a maximum absorbance of the [Symbol font/0x67]-globulin in the sample is equal to or greater than 6.31” is an intended result of a positively recited step. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I).
Regarding claim 14, modified Onuma teaches the sample analysis method according to claim 13, and the limitation “wherein a peak detection time of the y-globulin in the sample is equal to or less than 78.96 s” is an intended result of a positively recited step. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I).
Claims 6-8 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma and Onuma ’858, as applied to claim 1 above, and in view of Onuma et al. (JP2016136135A, English translation, hereinafter Onuma’135).
Regarding claim 6, modified Onuma teaches the sample analysis method according to claim 1, and Onuma further teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Note that Onuma’135 corresponds to the disclosure of JP 6052927 cited in Onuma.
Onuma is silent to wherein a weight average molecular weight of the cationic polymer is in a range from 15,000 g/mol to 150,000 g/mol.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). As the cationic polymer, from the viewpoint of improving analytical accuracy and shortening measurement time, polyethyleneimine, polyallylamine, polylysine, and combinations thereof are preferred, and polyallylamine is more preferred [para. 0017]. The weight-average molecular weight of the cationic polymer is 10000 or more from the viewpoint of improving the accuracy of analysis, and 500000 or less, or 300000 or less from the viewpoint of preventing an increase in solution viscosity [para. 0018]. 1.0% (W/V) polyethyleneimine (manufactured by Wako Pure Chemical Industries, Ltd., weight-average molecular weight: 70000) [para. 0060].
Since Onuma teaches a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064], and Onuma’135 of the Japanese Patent No. 6052927 teaches the use of polyethyleneimine with a weight-average molecular weight of 70000 as the cationic polymer [para. 0017, 0060], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyethyleneimine with a weight-average molecular weight of 70,000 as the cationic polymer, as taught by Onuma’135, since it would improve the accuracy of analysis and prevent an increase in solution viscosity [para. 0018 in Onuma’135]. The weight average molecular weight of the cationic polymer of polyethyleneimine falls within the claimed range from 15,000 to 150,000.
Regarding claim 7, modified Onuma teaches the sample analysis method according to claim 1, and Onuma further teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Note that Onuma’135 corresponds to the disclosure of JP 6052927 cited in Onuma.
Onuma is silent to wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.01 mass % to 10 mass %.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). In one or more embodiments, the content of the cationic polymer in the alkaline solution is 0.01% (W/V) or more, 0.05% (W/V) or more, or 0.1% (W/V) or more from the viewpoint of improving the accuracy of analysis, and 10.0% (W/V) or less, 8.0% (W/V) or less, or 5.0% (W/V) or less from the viewpoint of preventing an increase in solution viscosity [para. 0021]. Thus, Onuma’135 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.01 mass % to 10 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis.
Since Onuma teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064], and Onuma’135 of the Japanese Patent No. 6052927 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.01 mass % to 10 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis [para. 0021], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a content ratio of the cationic polymer with respect to a total mass of the alkaline solution being in a range from 0.01 mass % to 10 mass % since it would improve the accuracy of analysis and also prevent an increase in solution viscosity, as taught by Onuma’135.
Regarding claim 8, modified Onuma teaches the sample analysis method according to claim 1, and is silent to wherein a pH of the alkaline solution is in a range from 8.5 to 12.0.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). The pH of the alkaline solution is preferably 8.5 or higher, or 9.5 or higher from the viewpoint of improving the accuracy of analysis and shortening the measurement time. It is preferably 12.0 or lower, or 11.0 or lower from the viewpoint of preventing denaturation of hemoglobin [para. 0020].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pH of the alkaline solution in a range from 8.5 to 12.0, as taught by Onuma’135, since it would improve the accuracy of analysis; shorten the measurement time; and prevent denaturation of hemoglobin [para. 0020 in Onuma’135].
Regarding claim 15, modified Onuma teaches the sample analysis method according to claim 1, and is silent to wherein a pH of the alkaline solution is in a range from 9.0 to 11.0.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). The pH of the alkaline solution is preferably 8.5 or higher, or 9.5 or higher from the viewpoint of improving the accuracy of analysis and shortening the measurement time. It is preferably 12.0 or lower, or 11.0 or lower from the viewpoint of preventing denaturation of hemoglobin [para. 0020]. Thus, Onuma’135 teaches wherein a pH of the alkaline solution is in a range from 9.5 to 11.0.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pH of the alkaline solution in a range from 9.5 to 11.0, as taught by Onuma’135, since it would improve the accuracy of analysis; shorten the measurement time; and prevent denaturation of hemoglobin [para. 0020 in Onuma’135]. The disclosed pH range of from 9.5 to 11.0 falls within the claimed range from 9.0 to 11.0.
Regarding claim 16, modified Onuma teaches the sample analysis method according to claim 1, and is silent to wherein a pH of the alkaline solution is in a range from 9.0 to 10.0.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). The pH of the alkaline solution is preferably 8.5 or higher, or 9.5 or higher from the viewpoint of improving the accuracy of analysis and shortening the measurement time. It is preferably 12.0 or lower, or 11.0 or lower from the viewpoint of preventing denaturation of hemoglobin [para. 0020]. Thus, Onuma’135 teaches wherein a pH of the alkaline solution is in a range from 9.5 to 11.0.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pH of the alkaline solution in a range from 9.5 to 11.0, as taught by Onuma’135, since it would improve the accuracy of analysis; shorten the measurement time; and prevent denaturation of hemoglobin [para. 0020 in Onuma’135]. The disclosed pH range of from 9.5 to 11.0 overlaps with the claimed range from 9.0 to 10.0.
It would have been obvious to have selected and utilized a pH of the alkaline solution within the disclosed range of 9.5 to 11.0, as taught by Onuma’135, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Onuma’135 specifically teaches the pH range to be suitable for the alkaline solution for improving the accuracy of analysis and shortening the measurement time. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Regarding claim 17, modified Onuma teaches the sample analysis method according to claim 1, and Onuma further teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Note that Onuma’135 corresponds to the disclosure of JP 6052927 cited in Onuma.
Onuma is silent to wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.05 mass % to 8.0 mass %.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). In one or more embodiments, the content of the cationic polymer in the alkaline solution is 0.01% (W/V) or more, 0.05% (W/V) or more, or 0.1% (W/V) or more from the viewpoint of improving the accuracy of analysis, and 10.0% (W/V) or less, 8.0% (W/V) or less, or 5.0% (W/V) or less from the viewpoint of preventing an increase in solution viscosity [para. 0021]. Thus, Onuma’135 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.05 mass % to 8.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis .
Since Onuma teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064], and Onuma’135 of the Japanese Patent No. 6052927 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.05 mass % to 8.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis [para. 0021], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a content ratio of the cationic polymer with respect to a total mass of the alkaline solution being in a range from 0.05 mass % to 8.0 mass % since it would improve the accuracy of analysis and also prevent an increase in solution viscosity, as taught by Onuma’135.
Regarding claim 18, modified Onuma teaches the sample analysis method according to claim 1, and Onuma further teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Note that Onuma’135 corresponds to the disclosure of JP 6052927 cited in Onuma.
Onuma is silent to wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.1 mass % to 5.0 mass %.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). In one or more embodiments, the content of the cationic polymer in the alkaline solution is 0.01% (W/V) or more, 0.05% (W/V) or more, or 0.1% (W/V) or more from the viewpoint of improving the accuracy of analysis, and 10.0% (W/V) or less, 8.0% (W/V) or less, or 5.0% (W/V) or less from the viewpoint of preventing an increase in solution viscosity [para. 0021]. Thus, Onuma’135 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.1 mass % to 5.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis.
Since Onuma teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064], and Onuma’135 of the Japanese Patent No. 6052927 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.1 mass % to 5.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis [para. 0021], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a content ratio of the cationic polymer with respect to a total mass of the alkaline solution being in a range from 0.1 mass % to 5.0 mass % since it would improve the accuracy of analysis and also prevent an increase in solution viscosity, as taught by Onuma’135.
Regarding claim 19, modified Onuma teaches the sample analysis method according to claim 1, and Onuma further teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Note that Onuma’135 corresponds to the disclosure of JP 6052927 cited in Onuma.
Onuma is silent to wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 1.0 mass % to 3.0 mass %.
Onuma’135 teaches a sample analysis method that includes separating hemoglobin in a sample in an alkaline solution containing a cationic polymer by capillary electrophoresis (abstract and claim 1). In one or more embodiments, the content of the cationic polymer in the alkaline solution is 0.01% (W/V) or more, 0.05% (W/V) or more, or 0.1% (W/V) or more from the viewpoint of improving the accuracy of analysis, and 10.0% (W/V) or less, 8.0% (W/V) or less, or 5.0% (W/V) or less from the viewpoint of preventing an increase in solution viscosity [para. 0021]. Thus, Onuma’135 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.1 mass % to 5.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis.
Since Onuma teaches the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064], and Onuma’135 of the Japanese Patent No. 6052927 teaches wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is in a range from 0.1 mass % to 5.0 mass % from the viewpoint of preventing an increase in solution viscosity and improving the accuracy of analysis [para. 0021], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a content ratio of the cationic polymer with respect to a total mass of the alkaline solution being in a range from 0.1 mass % to 5.0 mass % since it would improve the accuracy of analysis and also prevent an increase in solution viscosity, as taught by Onuma’135.
The disclosed content ratio in a range from 0.1 mass % to 5.0 mass % overlaps with the claimed content ratio in a range of 1 mass % to 3.0 mass %.
It would have been obvious to have selected and utilized a content ratio of the cationic polymer with respect to a total mass of the alkaline solution within the disclosed range of 0.1 mass % to 5.0 mass %, as taught by Onuma’135, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Onuma’135 specifically teaches the content ratio of the cationic polymer with respect to a total mass of the alkaline solution to be suitable for improving the accuracy of analysis and preventing an increase in solution viscosity. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-7, filed 2/6/2026, with respect to claim objection and the 35 U.S.C. § 103 rejections have been fully considered, but are not persuasive.
Applicant’s Argument #1:
Regarding objection to claim 3, applicant argues at page 6 that a molecular weight is well known in the art as a relative molecular mass defined with reference to carbon-12, whose mass is defined as exactly 12. A molecular weight is calculated as the ratio of the mass of a molecule to one-twelfth the mass of a carbon-12 atom. As a result, the mass units cancel, and molecular weight is a dimensionless quantity. With respect to claim 6, Applicant has added unit.
Examiner’s Response #1
Applicant’s argument is not convincing since molecular weight is the total sum of the atomic weights of all atoms in a molecule. It represents the mass of one molecule, typically expressed in atomic mass units (amu) or Daltons (Da). Furthermore, applicant admitted that the molecular weight in claim 6 needs unit, which contradicts the argument regarding the molecular weight of claim 3 is a dimensionless quantity.
Applicant’s Argument #2:
Applicant argues at pages 6-7 that: (1) the combination of the cited references fails to disclose "a non surfactant-type sulfobetaine, a content ratio of which, with respect to a total mass of the sample, is in a range from 0.1 mass% to 30 mass%" as set forth in the claims; Onuma'858 does not disclose the content (concentration) of a non-surfactant-type sulfobetaine. Nowhere in the cited references disclose the recited concentration as being a result effective variable. (2) paragraph [0105] of Onuma describes a sample (diluent) adjusted to pH 6.0 that contains NDSB-201, while the alkaline solution containing the cationic polymer is disclosed separately. Onuma does not disclose or suggest that the non-surfactant-type sulfobetaine is present in the sample while separation is performed in an alkaline solution comprising a cationic polymer. Onuma '858 likewise fails to remedy this deficiency because Onuma '858 describes dilution ratios (paragraph [0087]), claim 1 of Onuma '858 specifies that the running buffer has a pH of 3.0 to 6.9. Thus, the reference does not disclose a configuration in which a sample comprising a non-surfactant-type sulfobetaine is separated in an alkaline solution comprising a cationic polymer. Accordingly, even when Onuma and Onuma '858 are combined, the references merely teach that a non-surfactant-type sulfobetaine may be used in a non-alkaline sample, and they fail to teach or suggest the claimed configuration.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. Regarding “a content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample is from 0.1 mass % to 30 mass %”, Firstly, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A). Secondly, Onuma teaches the sample was diluted with the diluent comprising 500 mM NDSB-201 to prepare the second liquid [para. 0105-0106], and Onuma ’858 teaches a similar sample analysis method wherein the sample is also diluted with a diluent and the dilution ratio affects the capillary electrophoresis separation resolution. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the dilution ratio of the sample in Onuma would also affect the CE separation resolution. Thus, the dilution ratio and accordingly a content ratio of the non-surfactant-type sulfobetaine of NDSB-201 with respect to a total mass of the sample affects the CE separation resolution since the sample is diluted with the diluent comprising the NDSB-201. Since the content ratio of the non-surfactant-type sulfobetaine with respect to a total mass of the sample affects the CE separation resolution via the dilution ratio, it is a result effect variable.
The arguments regarding “Onuma does not disclose or suggest that the non-surfactant-type sulfobetaine is present in the sample while separation is performed in an alkaline solution comprising a cationic polymer” are not convincing since Onuma teaches the sample is diluted with the diluent comprising 500 mM NDSB-201 to prepare a second liquid [para. 0051, 0105-0106]. Note that pH 6.0 is only for the diluent. Onuma does not teach that pH of the second liquid is 6.0. Onuma specifically teaches it is preferable to use an alkaline solution containing a cationic polymer for the first liquid and the second liquid. As the alkaline solution containing a cationic polymer, for example, the alkaline solution containing a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064, 0068]. Thus, the second liquid in Onuma is an alkaline solution containing a cationic polymer and components of the sample diluted with the diluent which comprises NDSB-201.
Examiner suggests applicant to remove the first compound (NDSB-201) from the list of claim 4, and further amend claim 1 by incorporating the amended claim 4 into claim 1.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/SHIZHI QIAN/Examiner, Art Unit 1795