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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11, 2026 has been entered.
Status of the Claims
Claims 1 and 10-13 have been amended; claims 22-23 are new; and claims 4 and 8-9 have been cancelled. Claims 1-3, 5-7, and 10-23 are examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(a) rejection previously set forth in the Final Office Action mailed February 11, 2026.
New grounds of claim objection are necessitated by the amendment as outlined below.
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and modified in response to the amendment.
New grounds of rejection under 35 U.S.C. § 103 for new claims 22-23 are necessitated by the amendment as outlined below.
The double patenting objection from the previous office action is maintained.
Claim Objection
Claims 22-23 are objected to because of the following informalities:
Claims 22-23: please amend “in range from” to -- in a range from--.
Appropriate correction is required.
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 1-3, 5, 7, and 10-23 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma et al. (JP2016136135A, English translation, hereinafter Onuma’135), and in view of Onuma (US20200011850A1).
Regarding claim 1, Onuma’135 teaches a sample analysis method (a method for analyzing a sample by capillary electrophoresis [abstract; Fig. 1]), comprising:
separating hemoglobin from a sample comprising the hemoglobin (separating hemoglobin in a sample by capillary electrophoresis [abstract]; the separation of hemoglobin includes separating at least one of HbS and HbA2, and preferably includes separating HbS and HbA2 [para. 0025]), in an alkaline solution by capillary electrophoresis (separating the hemoglobin in alkaline solution containing cationic polymer [abstract]),
wherein the alkaline solution comprises a cationic polymer (separating the hemoglobin in alkaline solution containing cationic polymer [abstract, para. 0033]; [para. 0016-0017] details the cationic polymer), and
the cationic polymer comprises at least one selected from the group consisting of diallylamine-acrylamide polymer (polyquaternium-7 which is copolymer of acrylamide and diallyldimethylammonium chloride [para. 0017]), dimethylamine-ammonia-epichlorohydrin polymer (cationic polymer having a quaternary ammonium base or a
group that can be ionized to a quaternary ammonium base includes dimethylamine-epichlorohydrin copolymer [para. 0017]), and diallyldimethylammonium chloride polymer (polyquaternium-6 which is poly(diallyldimethylammonium chloride) [para. 0017]).
Onuma’135 teaches separating hemoglobin from the sample containing the hemoglobin in the alkaline solution comprising the cationic polymer by capillary electrophoresis, thus is silent to: an amount of the alkaline solution is in a range from 1 µL to 70 µL; and separating albumin and γ-globulin from a sample comprising the albumin and the γ-globulin.
Onuma’135 further teaches from the viewpoint of improving separation accuracy, the sample is preferably a sample prepared using an alkaline solution containing a cationic polymer. The sample analysis method of the present disclosure includes
preparing a sample by diluting a sample raw material with an alkaline solution containing a cationic polymer. In one or more embodiments, the dilution ratio is 1.2 to 100 times, 2 to 60 times, or 3 to 50 times. When the sample raw material contains ionic components to an extent that may affect the resolution, the dilution ratio is, in one or more embodiments, 2 to 1000 times, 5 to 300 times, or 10 to 200 times [para. 0033]. Thus, Onuma’135 teaches diluting the sample raw material with the alkaline solution containing the cationic polymer for improving separation accuracy, thus the amount of the alkaline solution affects the dilution ratio, which further affects the separation accuracy and resolution, therefore, the amount of the alkaline solution is a result effective variable.
As the separation accuracy and resolution, and the dilution ratio are variables that can be modified, among others, by adjusting the amount of the alkaline solution which dilutes the sample raw material, the precise amount of the alkaline solution 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 amount of the alkaline solution being in a range from 1 µL to 70 µL 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 amount of the alkaline solution being in a range from 1 µL to 70 µL to obtain the desired dilution ratio and accordingly the desired separation accuracy and 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.).
Onuma’135 is silent to: separating albumin and γ-globulin from a sample comprising the albumin and the γ-globulin.
Onuma teaches a sample analysis method (a sample analysis method by capillary electrophoresis [abstract; Figs. 4-5]) for separating components contained in blood including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen [para. 0046], in an alkaline solution by capillary electrophoresis (in the separation process [S5], a voltage may be applied after the anode is brought into contact with the second liquid stored in the sample reservoir 1, and the cathode is brought into contact with the first liquid stored in the electrophoresis liquid reservoir 3. It is preferable to use an alkaline solution containing a cationic polymer for the first liquid and the second liquid [para. 0068]). Onuma further teaches a cationic polymer described in Japanese Patent No. 6052927 may be used [para. 0064]. Onuma’135 is the Japanese Patent No. 6052927. Thus, Onuma teaches an analysis method for separating components including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen contained in the blood, in an alkaline solution comprising a cationic polymer by capillary electrophoresis, and the cationic polymer is the same as that of Onuma’135. Therefore, the sample analysis methods in both Onuma’135 and Onuma are essentially the same, but are used to separate different components in the sample.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take sample analysis method of Onuma’135 to separate components including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen contained in blood, as taught by Onuma, since Onuma teaches the same sample analysis method for separating and analyzing components including hemoglobin (Hb), albumin (A1b), globulin (α1, α2, β, and γ globulins), and fibrinogen contain in blood [para. 0046].
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 [para. 0046 in Onuma], 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).
Regarding claim 2, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein a weight average molecular weight of the cationic polymer is from 10,000 to 500,000 (the weight-average molecular weight of the cationic polymer is 10,000 or more from the viewpoint of improving the accuracy of analysis, and 500,000 or less from the viewpoint of preventing an increase in solution viscosity [para. 0018]).
Regarding claim 3, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein a weight average molecular weight of the cationic polymer is from 10,000 to 500,000 (the weight-average molecular weight of the cationic polymer is 10,000 or more from the viewpoint of improving the accuracy of analysis, and 500,000 or less from the viewpoint of preventing an increase in solution viscosity [para. 0018]).
Onuma’135 is silent to wherein a weight average molecular weight of the cationic polymer is from 15,000 to 150,000, but the disclosed molecular weight range of 10,000 to 500,000 overlaps with the claimed range.
It would have been obvious to have selected and utilized a cationic polymer with a weight average molecular weight within the disclosed range, 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 range to be suitable for the cationic polymer from the viewpoint of improving the accuracy of analysis and preventing an increase in solution viscosity [para. 0018]. 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 5, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches 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 % (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]).
Regarding claim 7, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein a pH of the alkaline solution is from 8.5 to 12.0 (the pH of the alkaline solution is preferably 8.5 or higher, or 9.5 or higher and it is preferably 12.0 or lower, or 11.0 or lower [para. 0020]).
Regarding claim 10, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein the cationic polymer comprises the diallylamine-acrylamide polymer (polyquaternium-7 which is copolymer of acrylamide and diallyldimethylammonium chloride [para. 0017]).
Regarding claim 11, modified Onuma’135 teaches the sample analysis method according to claim 1, wherein the cationic polymer comprises the dimethylamine-ammonia-epichlorohydrin polymer (cationic polymer having a quaternary ammonium base or a group that can be ionized to a quaternary ammonium base includes dimethylamine-epichlorohydrin copolymer [para. 0017]).
Regarding claim 12, modified Onuma’135 teaches the sample analysis method according to claim 1, and is silent to wherein the cationic polymer comprises the allylamine-diallylamine polymer.
Onuma’135 does teach wherein examples of cationic polymers having primary to tertiary amino groups or groups that can be ionized to primary to tertiary amino groups include polyallylamine, polyvinylamine, polylysine, polyarginine, polyhistidine, polyornithine, polydiallylamine, and polymethyldiallylamine [para. 0017]. The cationic polymers can be used alone or in combination of two or more kinds [para. 0016].
Since Onuma’135 teaches that the polymer of allylamine and the polymer of diallyalamine are both suitable as the cationic polymer, and the cationic polymers can be used alone or in combination of two or more kinds, the skilled artisan would have been motivated to use the mixture of allylamine and diallyamine to form allylamine-diallylamine polymer since it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. Furthermore, the formed allylamine-diallylamine polymer is also a cationic polymer carrying a positive charge, and would perform the functions of the cationic polymers of the allylamine and the diallyamine.
Regarding claim 13, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein the cationic polymer comprises the diallyldimethylammonium chloride polymer (polyquaternium-6 which is poly(diallyldimethylammonium chloride) [para. 0017]).
Regarding claim 14, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein the separating is performed in an electrophoresis chip (capillary electrophoresis chip in Fig.1 [para. 0013, 0046]) comprising a sample holding tank (sample reservoir 11 in Fig.1A [para. 0046]), an electrophoretic liquid holding tank (an electrophoresis buffer reservoir 12 in Fig.1A [para. 0046]), and a capillary flow path (capillary channel 10 in Fig.1A [para. 0046]), wherein the sample holding tank and the electrophoretic liquid holding tank are communicated with each other via the capillary flow path (see Fig.1A).
Regarding claim 15, modified Onuma’135 teaches the sample analysis method according to claim 14, and Onuma’135 teaches wherein a cross section of the capillary flow path is rectangular or circular (the cross-sectional shape of the capillary channel is not particularly limited and may be circular or rectangular [para. 0027]).
Regarding claim 16, modified Onuma’135 teaches the sample analysis method according to claim 14, and Onuma’135 teaches wherein a cross section of the capillary flow path is rectangular (the cross-sectional shape of the capillary channel is not particularly limited and may be circular or rectangular [para. 0027]).
Onuma’135 is silent to wherein the rectangular capillary flow path having a width and a height in a range of 1 µm to 1000 µm.
Onuma teaches capillary flow path having depth 0.04 mm×width 0.04 mm×length 30 mm [para. 0102]. Thus, Onuma teaches wherein the rectangular capillary flow path having a width and a height in a range of 1 µm to 1000 µm (depth 0.04 mm×width 0.04 mm; 0.04 mm is 40 µm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the capillary flow path of modified Onuma’135 to a rectangular capillary flow path having a width of 40 µm and a height of 40 µm, as taught by Onuma, since Onuma teaches the dimensions of the width and the height of the capillary flow path suitable for sample analysis by capillary electrophoresis [para. 0102].
Regarding claim 17, modified Onuma’135 teaches the sample analysis method according to claim 14, and Onuma’135 teaches wherein a cross section of the capillary flow path is circular (capillary channel is a tube having an inner diameter of 100 µm or less [para. 0027]), a radius of which is in a range of 10 µm to 100 µm (the inner diameter of the capillary channel is 25 μm or more, and 100 μm or less [para. 0027]; thus the radius is in a range of 12.5 μm to 50 μm, falling within the claimed radius range).
Regarding claim 18, modified Onuma’135 teaches the sample analysis method according to claim 14, and Onuma’135 teaches wherein a length of the capillary flow path is in a range of 20 mm to 150 mm (the length of the capillary channel is 20 mm or more and 150 mm or less [para. 0027]).
Onuma’135 is silent to wherein the length of the capillary channel is in a range of 100 mm to 150 mm, but the disclose range of the length overlaps with the claimed length range.
It would have been obvious to have selected and utilized a capillary channel with a length within the disclosed length range, 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 range to be suitable for the length of the capillary channel [para. 0027]. 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 19, modified Onuma’135 teaches the sample analysis method according to claim 14, wherein the separating includes applying an electric voltage in a range of 500 V to 10000 V to the electrophoresis chip (Onuma’135 teaches the applied voltage is 1500 V [para. 0064]; Onuma also teaches the applied voltage is about 1500 V [para. 0114]).
Regarding claim 20, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein the cationic polymer is a polymer having a quaternary ammonium base (the cationic group may be a polymer having a quaternary ammonium base [para. 0016]; the cationic polymer having a quaternary ammonium base or a group that can be ionized to a quaternary ammonium base includes polyquaternium, dimethylamine-epichlorohydrin copolymer [para. 0017]).
Regarding claim 21, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein the alkaline solution has a pH in a range of 8.5 to 12.0 (the pH of the alkaline solution is preferably 8.5 or higher, or 9.5 or higher and it is preferably 12.0 or lower, or 11.0 or lower [para. 0020]).
Regarding claim 22, modified Onuma’135 teaches the sample analysis method according to claim 1, and does not explicitly teach wherein an amount of the sample is in a range from 1 µL to 70 µL.
As outlined in the rejection of claim 1 above, Onuma’135 teaches from the viewpoint of improving separation accuracy, the sample is preferably a sample prepared using an alkaline solution containing a cationic polymer. The sample analysis method of the present disclosure includes preparing a sample by diluting a sample raw material with an alkaline solution containing a cationic polymer. In one or more embodiments, the dilution ratio is 1.2 to 100 times, 2 to 60 times, or 3 to 50 times. When the sample raw material contains ionic components to an extent that may affect the resolution, the dilution ratio is, in one or more embodiments, 2 to 1000 times, 5 to 300 times, or 10 to 200 times [para. 0033]. Thus, Onuma’135 teaches diluting the sample raw material with the alkaline solution for improving separation accuracy, and the amount of the sample containing ionic components affects the separation accuracy and resolution, therefore, is a result effective variable.
As the separation accuracy and resolution, and the dilution ratio are variables that can be modified, among others, by adjusting the amount of the sample, the precise amount 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 amount of the sample being in a range from 1 µL to 70 µL 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 amount of the sample being in a range from 1 µL to 70 µL to obtain the desired dilution ratio and accordingly the desired separation accuracy and 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 23, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma’135 teaches wherein a volume of at least one of a sample holding tank configured to hold the sample or an electrophoretic liquid holding tank configured to hold the alkaline solution is in range from 1 mm3 to 1000 mm3 (the volume of the sample holding tank 11 are 1 mm3 to 1000 mm3 [para. 0047]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Onuma’135 and Onuma, as applied to claim 1 above, and further in view of Shigemitsu et al. (JP2018072330A, English translation).
Regarding claim 6, modified Onuma’135 teaches the sample analysis method according to claim 1, and Onuma teaches wherein an electrophoresis time of the capillary electrophoresis in the separation is 35 sec [para. 0115].
Modified Onuma’135 is silent to wherein an electrophoresis time of the capillary electrophoresis in the separation is from 50 seconds to less than 250 seconds.
Shigemitsu teaches a sample analysis method for separating and analyzing components including hemoglobin (Hb), albumin (Alb), globulins (α1, α2, β, γ globulins), and fibrinogen contained in blood by a capillary electrophoresis [para. 0018-0019], wherein a cationic polymer is immobilized on inner walls of the sample section and the analysis section (claim 1), and examples of the cationic polymers include polyquaternium-6 (poly(diallyldimethylammonium chloride)) and polyquaternium-7 (copolymer of acrylamide and diallyldimethylammonium chloride) [para. 0043]. Shigemitsu further teaches electrophoresis was carried out for 60 seconds [para. 0087]. Note that polyquaternium-6 and polyquaternium-7 are, respectively, the diallyldimethylammonium chloride polymer and the diallylamine-acrylamide polymer of instant claim 1 above. Thus, Shigemitsu teaches a sample analysis method that can be used to separate albumin and γ globulin by capillary electrophoresis using the same cationic polymer and the electrophoresis time in the separation is 60 sec.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the electrophoresis time in modified Onuma’135 to 60 seconds, as taught by Shigemitsu, since Shigemitsu teaches a suitable alternative electrophoresis time of 60 seconds that can be used to separate albumin and γ globulin by capillary electrophoresis [para. 0018-0019, 0087].
Double Patenting Objection
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
Applicant is advised that should claim 7 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the instant case, the limitation of claim 21 is essentially the same as that recited in claim 7.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 5-6, filed 5/11/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered.
Applicant’s Argument #1:
Applicant argues that the amended claim 1 recites “an amount of the alkaline solution is in a range from 1 μL to 70 μL”. Neither Onuma’135, Onuma nor Shigemitsu teach or suggest this feature.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the modified rejection for claim 1 above.
Conclusion
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/SHIZHI QIAN/Examiner, Art Unit 1795
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