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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 20, 2026 has been entered.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
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.
Claim(s) 1, 4-9, and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuma (US 2016/0209359) in view of Oishi (US 2010/0006436), and further in view of Breadmore (US 2019/0353614).
Regarding claims 1 and 12-14, Onuma teaches a sample analysis method ([Abstract]), comprising:
separating a protein from a sample comprising the protein ([Abstract]: separating hemoglobin in a sample), in an alkaline solution by capillary electrophoresis ([Abstract]),
wherein separation of the protein is performed (¶24: fractions of hemoglobin in a sample can be separated), and
the alkaline solution comprises a cationic polymer ([Abstract]).
Onuma fails to teach the separation is performed in a presence of a cationic low- molecular compound having two or three primary amino groups, the cationic low-molecular compound being comprised in the alkaline solution during the separating of the protein, a content ratio of the cationic low-molecular compound with respect to a total mass of the alkaline solution is from 0.01 mass% to 10 mass%, and the cationic low-molecular compound comprises 1,2-diaminopropane (claim 1) or wherein a content ratio of the cationic low-molecular compound with respect to a total mass of the alkaline solution is from 0.05 mass% to 5 mass% (claim 12) or wherein a content ratio of the cationic low-molecular compound with respect to a total mass of the alkaline solution is from 0.1 mass% to 3 mass% (claim 13) or wherein a content ratio of the cationic low-molecular compound with respect to a total mass of the alkaline solution is from 0.3 mass% to 1 mass% (claim 14).
However, Oishi teaches a method for measuring hemoglobin (¶13), using a migration path having an inner surface coated with a cationic substance to be immobilized on the inner surface (¶14). A low-molecular-weight hydrophilic compound having a cationic group is linked to the inner surface of the migration path by a covalent bond (¶26). The hydrophilic compound having a cationic group may have a repetitive structure such as dimer and trimer as long as its molecular weight is 800 or less (¶51), and an example is propylenediamine (¶54). As evidenced by PubChem, propylenediamine is 1,2-diaminopropane (PubChem: propylenediamine, p. 8, section 2.4.2). The desirable lower limit of the concentration of the solution containing the hydrophilic compound having a cationic group is 0.1% by weight, and the desirable upper limit thereof is 30% by weight (¶63), which overlaps the claimed ranges of the claims 1 and 12-14. Further, Onuma teaches the capillary channel is preferably coated with a cationic substance (¶47), which may be the cationic polymer or a silane coupler having a cationic functional group (¶48), suggesting the electrophoresis solution may include the cationic polymer only or both cationic polymer and the cationic coating substance. Breadmore teaches the separation channel or capillary may be pre-coated or coated in situ (¶101). Thus, the combined Onuma, Oishi, and Breadmore renders it obvious that a cationic substance (Onuma, ¶47), e.g., propylenediamine (Oishi, ¶54), can be used to coat the capillary channel in situ (Breadmore, ¶101), i.e., in the alkaline solution during the separating of the protein.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by incorporating the hydrophilic low-molecular-weight compound comprising a cationic group of Oishi (Oishi, ¶26; e.g., ¶54: propylenediamine) into the alkaline solution of Onuma (Onuma, ¶55) for in situ coating (Breadmore, ¶101) because the hydrophilic low-molecular-weight compound comprising a cationic group would coat the inner surface of the migration path and thus the migration path having the cationic inner surface would avoid non-specific adsorption of measurement components and enable high accuracy measurement (Oishi, ¶17). Here, Choosing from a finite number of identified, predictable solutions (i.e., pre-coated or coated in situ), with a reasonable expectation of success is prima facie obvious. MPEP 2141(III)(E). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I). Examiner notes that the hydrophilic low-molecular-weight compound having a cationic group of Oishi does not have to substitute the cationic low-molecular weight of Onuma because the former is for coating the migration path while the latter is a pH adjuster.
Regarding claim 4, Onuma, Oishi, and Breadmore disclose all limitations of claim 1, but fail to teach wherein a ratio of a content ratio of the cationic low-molecular compound to a content ratio of the cationic polymer in the alkaline solution is from 0.001 to 1000.
However, Onuma teaches the content of the cationic polymer in the alkaline solution is 0.01% (W/V) from the viewpoint of improving the accuracy of analysis, and more or 5.0% (W/V) from the viewpoint of preventing an increase in solution viscosity, rendering the content ratio of the cationic polymer in the alkaline solution a result-effective variable (¶38). Further, Oishi teaches a hydrophilic compound having a cationic group, e.g., propylenediamine, having a desirable lower and upper limits of the concentrations from 0.1% to 20% by weight (¶63). The combined Onuma and Oishi would render a ratio of the content ratio of the cationic low-molecular compound to a content ratio of the cationic polymer in the alkaline solution a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma, Oishi, and Breadmore by adjusting the ratio of the content ratio of the cationic low-molecular compound to a content ratio of the cationic polymer within the claimed range because the ratio of the content ratio of the cationic low-molecular compound to a content ratio of the cationic polymer is a result-effective variable and can be optimized through routine experimentation. MPEP 2144.05 (II)(B).
Regarding claim 5, Onuma, Oishi, and Breadmore disclose all limitations of claim 1, but fail to teach wherein the cationic low- molecular compound comprises at least one selected from the group consisting of 3,3'-diamino-N- methyldipropylamine, N,N'-bis(3-aminopropyl)ethylenediamine, 3,3'-diaminodipropylamine, and tris(2-aminoethyl)amine.
However, Oishi teaches the hydrophilic compound having a cationic group is an aminoalkanes, such as trimethylamine, triethylamine, tributylamine, and derivatives, salts, substitution products (¶54). Here, trimethylamine, triethylamine, and tributylamine are tri-amines that each of H of NH3 is substituted by methyl, ethyl, or butyl groups respectively (see PubChem documents for these three tri-amines: trimethylamine, triethylamine, and tributylamine). Each of them has similar structure to that of tris(2-aminoethyl)amine, in which each of H of NH3 is substituted by a aminoethyl group (see PubChem: tris(2-aminoethyl)amine). Further, Oishi teaches 2-aminoehtyl is a substitution group for the hydrophilic compound having a cationic group (Oishi, ¶54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma, Oishi, and Breadmore by using a tri-amine with each H substituted with an alkane group, e.g., methyl, ethyl, butyl (Oishi, ¶54), or aminoethyl as recited because tri-amines and their derivative and substitution products are suitable hydrophilic compound having a cationic group. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Further, the instant application does not provide the recited compounds show any surprising or unexpected results from the recited tri-amines and/or tetra-amines and their derivatives to show non-obviousness.
Regarding claim 6, Onuma teaches wherein the protein comprises hemoglobin ([Abstract]).
Regarding claims 7 and 15-16, Onuma, Oishi, and Breadmore disclose all limitations of claim 1, but fail to teach wherein a weight average molecular weight of the cationic polymer is from 15,000 to 150,000 (claim 7) or wherein a weight average molecular weight of the cationic polymer is from 20,000 to 130,000 (claim 15) or wherein a weight average molecular weight of the cationic polymer is from 20,000 to 100,000 (claim 16).
However, Onuma teaches the weight-average molecular weight of the cationic polymer is 10,000 or more and 300,000 or less (¶34), which overlaps the claimed ranges of the claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma, Oishi, and Breadmore by adjusting the molecular weight of the cationic polymer within the claimed range because they are suitable molecular weight of the cationic polymer for improving the accuracy while preventing an increase in solution viscosity (¶34). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 8, Onuma, Oishi, and Breadmore disclose all limitations of claim 1, but fail to teach wherein a content ratio of the cationic polymer with respect to a total mass of the alkaline solution is from 0.01 mass% to 10 mass%.
However, Onuma teaches the content of the cationic polymer in the alkaline solution is 0.01% (W/V) from the viewpoint of improving the accuracy of analysis, and more or 5.0% (W/V) from the viewpoint of preventing an increase in solution viscosity, rendering the content ratio of the cationic polymer in the alkaline solution a result-effective variable (¶38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma, Oishi, and Breadmore by adjusting the content of the cationic polymer in the alkaline solution with respect to a total mass of the alkaline solution within the claimed range because the content of the cationic polymer in the alkaline solution is a result-effective variable and can be optimized through routine experimentation to achieve both improved accuracy of analysis and prevention of an increase in the solution viscosity (¶38). MPEP 2144.05 (II)(B).
Regarding claim 9, Onuma teaches wherein a pH of the alkaline solution is from 8.5 to 12.0 (¶37: the pH of the alkaline solution is preferably 8.5 or higher and preferably 12.0 or lower).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuma in view of Oishi, or alternatively, over Onuma in view of Oishi and Breadmore.
Regarding claim 10, Onuma teaches a capillary electrophoresis solution (¶24: conducting capillary electrophoresis in an alkaline solution), comprising:
a cationic polymer (¶24: the alkaline solution containing a cationic polymer);
wherein the capillary electrophoresis solution is used for separation of a protein by capillary electrophoresis ([Abstract]: separating hemoglobin in a sample by capillary electrophoresis; further, this limitation is deemed to be functional limitation in apparatus claims regarding to intended use. MPEP 2114 (II). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), and
the cationic low-molecular compound comprises 1,2-diaminopropane (¶54: propylenediamine; as evidenced by PubChem, propylenediamine is 1,2-diaminopropane (PubChem: Propylenediamine, p. 8, section 2.4.2)).
Onuma fails to teach a cationic low-molecular compound having two or three primary amino groups, wherein a content ratio of the cationic low-molecular compound with respect to a total mass of the alkaline solution is from 0.01 mass% to 10 mass%.
However, Oishi teaches a method for measuring hemoglobin (¶13), using a migration path having an inner surface coated with a cationic substance to be immobilized on the inner surface (¶14). A low-molecular-weight hydrophilic compound having a cationic group is linked to the inner surface of the migration path by a covalent bond (¶26). The hydrophilic compound having a cationic group may have a repetitive structure such as dimer and trimer as long as its molecular weight is 800 or less (¶51), and the desirable lower limit of the concentration of the solution containing the hydrophilic compound having a cationic group is 0.1% by weight, and the desirable upper limit thereof is 30% by weight (¶63), which overlaps the claimed range. Further, Onuma teaches the capillary channel is preferably coated with a cationic substance (¶47), which may be the cationic polymer or a silane coupler having a cationic functional group (¶48), suggesting the electrophoresis solution may include the cationic polymer only or both cationic polymer and the cationic coating substance.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by incorporating the hydrophilic low-molecular-weight compound having a cationic group of Oishi (Oishi, ¶26; e.g., ¶54: propylenediamine) into the alkaline solution of Onuma (Onuma, ¶55) with a surface coating because the hydrophilic low-molecular-weight compound comprising a cationic group would coat the inner surface of the migration path and thus the migration path having the cationic inner surface would avoid non-specific adsorption of measurement components and enable high accuracy measurement (Oishi, ¶17). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I). Examiner notes that the hydrophilic low-molecular-weight compound having a cationic group of Oishi does not have to substitute the cationic low-molecular weight of Onuma because the former is for coating the migration path while the latter is a pH adjuster.
Alternatively, in response to the alleged that Onuma and Oishi do not explicitly disclose both cationic polymer and cationic low-molecular compound are in the alkaline solution, Breadmore teaches the separation channel or capillary may be pre-coated or coated in situ (¶101). Onuma teaches the capillary channel is preferably coated with a cationic substance (¶47), which may be the cationic polymer or a silane coupler having a cationic functional group (¶48), suggesting the electrophoresis solution may include the cationic polymer only or both cationic polymer and the cationic coating substance.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma and Oishi by incorporating both the low-molecular-weight compound and the cationic polymer into the alkaline solution of Onuma (Onuma, ¶¶47-48) for in situ coating (Breadmore, ¶101). Here, Choosing from a finite number of identified, predictable solutions (i.e., pre-coated or coated in situ), with a reasonable expectation of success is prima facie obvious. MPEP 2141(III)(E).
Regarding claim 11, Onuma teaches a sample analysis kit (¶15), comprising:
a container (¶15) comprising the capillary electrophoresis solution according to claim 10 (as described in claim 10); and
an electrophoresis chip (Fig. 1; ¶69) comprising a sample holding tank (Fig. 1; ¶69: a sample reservoir 11), an electrophoretic liquid holding tank (Fig. 1; ¶69: a running buffer reservoir 12), and a capillary flow path (Fig. 1; ¶69: a capillary channel 10),
wherein the sample holding tank and the electrophoretic liquid holding tank are communicated with each other via the capillary flow path (Fig. 1: indicating the sample reservoir 11 and the running buffer reservoir 12 are communicated with each other via the capillary channel 10).
Response to Arguments
Applicant’s arguments have been considered and they are unpersuasive.
Applicant argues none of the references teaches the cationic low-molecular compound is at least one of the recited groups in amended claim 1 (Response, p. 5). This argument in unpersuasive because Oishi explicitly disclose the hydrophilic compound having a cationic group is propylenediamine (Oishi, ¶54), which is recited 1,2-diaminopropane (PubChem: Propylenediamine, p. 8, section 2.4.2).
Applicant argues the combination of Onuma, Oishi, and Breadmore fails to teach or suggest the cationic low-molecular compound is comprised in the alkaline solution during the separating of the protein. This argument is unpersuasive because Breadmore teaches the separation channel or capillary may be pre-coated or coated in situ (¶101), and the cationic substance (Onuma, ¶47), e.g., propylenediamine (Oishi, ¶54), is in the alkaline solution during the separating of the protein when it is used to coat the capillary channel in situ.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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