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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4th, 2026 has been entered.
Status of the Claims
Claim 1 has been amended; Claims 3, 10, 12, 18, 20-21, 23-26, 30-31, and 33-71 have been previously cancelled; Claims 27-29 and 32 have previously been withdrawn. Claims 1-2, 4-9, 11, 13-17, 19, and 22 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome the 35 U.S.C. § 103 rejections previously set forth in the Final Office Action mailed February 6th, 2026.
New grounds of claim objection and rejection under 35 U.S.C. § 112(b) and 35 U.S.C. § 103 are necessitated by Applicant’s amendments.
Claim Objections
Claims 14-15 is objected to because of the following informalities:
Claim 14-15, please amend “ranging from between” to “ranging from .
Appropriate correction is required.
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 1-2, 4-9, 11, 13-17, 19, and 22 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.
Regarding Claim 1, for the limitations “wherein the at least one sample loading chamber is in communication with at least one first electrode, the at least one waste collection chamber is in communication with at least one second electrode, and the at least one sample collection chamber is in communication with at least one third electrode”, it is unclear if “the at least one sample loading chamber”, “the at least one waste collection chamber”, “the at least one sample collection chamber” refers to, respectively, each of the at least one sample loading chamber, the at least one waste collection chamber, and the at least one sample collection chamber, or one of (then which one) of the at least one sample loading chambers, the at least one waste collection chambers, and the at least one sample collection chambers. Note that each of the one or more independently operable separation conduits comprise at least one sample loading chamber, at least one waste collection chamber, and at least one sample collection chamber. Claims 2, 4-9, 11, 13-17, 19, and 22 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding Claim 9, the limitation “the at least one sample loading chamber” is unclear if “the at least one sample loading chamber” refers to each of the at least one sample loading chambers, or one of (then which one) the at least one sample loading chambers. Claim 11 is further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 9.
Regarding Claim 11, the limitation “the at least one sample loading chamber” is unclear if “the at least one sample loading chamber” refers to each of the at least one sample loading chambers, or one of (then which one) the at least one sample loading chambers.
Regarding Claim 14, the limitation “the at least one sample loading chamber” is unclear if “the at least one sample loading chamber” refers to each of the at least one sample loading chambers, or one of (then which one) the at least one sample loading chambers. Claim 15 is further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 14.
Regarding Claim 16, “the branched transfer conduit” lacks antecedent basis.
Regarding Claim 19, the limitations “the at least one waste collection chamber” and “the at least one sample collection chamber” are unclear if “the at least one waste collection chamber” and “the at least one sample collection chamber” refers to, respectively, each of the at least one waste collection chambers and the at least one sample collection chambers, or one of (then which one) of the at least one waste collection chambers, and the at least one sample collection chambers. Claim 22 is further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 19.
Regarding Claim 22, the limitation “the at least one sample loading chamber” is unclear if “the at least one sample loading chamber” refers to each of the at least one sample loading chambers, or one of (then which one) the at least one sample loading chambers.
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 1-2, 4-6, 8, 13-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Meller (US 2020/0171489 A1) in view of Misawa (WO2008041718A1, provided in IDS submitted 01/16/2026; English translation provided) and Smejkal (Microfluidic isotachophoresis: A review. Electrophoresis 2013; 34, 1493-1509).
Regarding Claim 1, Meller teaches an electrophoretic device (ITP device in Figure 1A to 1C [para. 0105], with Figure 3 providing overhead views of the ITP device embodiments [para. 0137]) comprising: one or more independently operable separation conduits (one independently operable separation conduit is used: an isotachophoresis conduit by applying an electric field between electrodes 107 and electrode 110 [para. 0090], and applying an electric field between electrode 107 and electrode 120 [para. 0103]); wherein the independently operable separation conduit comprises at least one sample loading chamber (left reservoir 105 in Figure 1A [para. 0106]),- at least one waste collection chamber (right reservoir 108 in Figure 1A [para. 0106]), and at least one sample collection chamber (lower reservoir 121 in Figure 1B [para. 0103]), wherein each of the at least one sample loading chamber, the at least one waste collection chamber, and the at least one sample collection chambers are fluidically coupled to each other through a branched transfer channel (as illustrated in Figure 1B, left reservoir 105, right reservoir 108, and lower reservoir 121 are connect via a branched transfer channel and in fluid contact [para. 0090, 0103]; Figure 3B gives an alternate view also illustrating the fluid connection as well as the branched channel); and wherein the at least one sample loading channel is in communication with at least one first electrode (left reservoir 105 is filled with terminating electrolyte 106 electrically connected to electrode [also called separation cathode] 107 [para. 0106]), the at least one waste collection chamber is in communication with at least one second electrode (right reservoir 108 is filled with leading electrolyte and electrically contacted by electrode [also called separation anode] 110 [para. 0106]), and the at least one sample collection chamber is in communication with at least one third electrode (electrode 120 is configured to contact the fluid in lower reservoir 121 [para. 0103]).
Meller is silent on wherein each of the at least one sample loading chamber, the at least one waste collection chamber, and the at least one sample collection chamber, are (i) within the same layer of the electrophoretic device (ii) arranged within the same plane, and the branched transfer channel comprising a primary channel in communication with the at least one sample loading chamber and first and second secondary channels branching from the primary channel, the first secondary channel being in communication with the at least one waste collection chamber and the second secondary channel being in communication with the at least one sample collection chamber.
Misawa teaches a microchip electrophoresis device (abstract), and teaches wherein each of the at least one sample loading chamber, the at least one waste collection chamber, and the at least one sample collection chamber are within the same layer of the electrophoretic device (as illustrated in Figure 2A, all channels and chambers including sample reservoir 110, sample discharge reservoir 112, and collection reservoir 118 [para. 0046-0047]).
Meller and Misawa are considered analogous art to the claimed inventions because they are in the same field of electrophoretic devices. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the at least one sample collection chamber of Meller to be within the same layer of the electrophoretic device as the at least one sample loading chamber and the at least one waste collection chamber, as taught by Misawa, as an electrophoresis platform with this setup allows for successful capture of the sample (Misawa, [paras. 0013 and 0045]).
Modified Meller is silent on wherein each of the at least one sample loading chamber, the at least one waste collection chamber, and the at least one sample collection chamber are (ii) arranged within the same plane, and the branched transfer channel comprising a primary channel in communication with the at least one sample loading chamber and first and second secondary channels branching from the primary channel, the first secondary channel being in communication with the at least one waste collection chamber and the second secondary channel being in communication with the at least one sample collection chamber.
Smejkal teaches electromigration methods including CE and ITP (abstract), and teaches wherein each of the at least one sample loading chamber, the at least one sample collection chamber, and the at least one sample collection chamber are (ii) arranged within the same plane (as shown in Figure 6 on page 1502, an ITP chip with five reservoirs has a sample loading chamber at 1, a waste collection chamber at 4, and a sample collection chamber at 5 are arranged in the same plane; Note that waste collection chamber can be either side reservoirs 2,3, and 4 [first para. col. 2, page 1501] and that sample collection chamber can be located at the end of separation chamber 5 [first para. col. 1, page 1506]. Other examples include Figure 3A on page 1500 where all chambers are located in the same plane), and the branched transfer channel comprising a primary channel (primary channel can be the green horizontal channel in f connected to reservoir 1 in Fig. 6 on page 1502) in communication with the at least one sample loading chamber (sample is loaded in reservoir 1 in Fig. 6 on page 1502) and first and second secondary channels branching from the primary channel (first secondary branching channel can be channel connecting reservoir 4 to green channel, and the second secondary channel is the horizontal channel from 4 to 5 in Fig. 6 on page 1502), the first secondary channel being in communication with the at least one waste collection chamber (waste collection chamber corresponds to reservoir 4 in Fig. 6 on page 1502) and the second secondary channel being in communication with the at least one sample collection chamber (sample collection chamber corresponds to reservoir 5 in Fig. 6 on page 1502).
Smejkal and modified Meller are considered analogous art to the claimed inventions because they are in the same field of electrophoretic devices. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the at least one sample loading chamber, the at least one sample collection chamber, and the at least one waste collection chamber of modified Meller to be (ii) arranged within the same plane, and to modify the branched transfer channel of modified Meller to comprise a primary channel in communication with the at least one sample loading chamber and first and second secondary channels branching from the primary channel, the first secondary channel being in communication with the at least one waste collection chamber and the second secondary channel being in communication with the at least one sample collection chamber, as taught by Smejkal, as this configuration allows for separating analytes using ITP in a microchip setup (Smejkal, [Figure 6]).
Regarding Claim 2, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches further comprising at least two wires (Figure 3A illustrates a wire connecting the left reservoir and right reservoir; Figure 3C teaches a second wire connecting the left reservoir with the lower reservoir), wherein a first of the at least two electrical wires couple the at least one first electrode to the at least one second electrode (as illustrated in Figure 3A, a wire connects electrode 107 in the left reservoir 105 and electrode 110 in the right reservoir 108 are configured to generate an electric field [para. 0090]).
Regarding Claim 4, modified Meller teaches the electrophoretic device of claim 2.
Meller teaches wherein a second of the at least two electrical wires couple the at least one first electrode to the at least one third electrode (as illustrated in Figure 3C, a wire connects electrodes 107 and 120 [para. 0103]).
Regarding Claim 5, modified Meller teaches the electrical device of claim 1.
Meller teaches further comprising a control system (the system further comprises a control unit or computer [para. 0147]).
Regarding Claim 6, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches further comprising one or more feedback control devices (automated feedback control can be used to remove the separation voltage to align the focused sample zone 119 in the channel [para. 0110]).
Regarding Claim 8, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches wherein a first portion of a wall of each of the at least one sample loading chambers comprises a first aperture in communication with an inlet of the branched transfer channel (as illustrated in Figure 1A, left reservoir 105 is round so that the walls of left reservoir 105 forms an opening with first channel section 102 [para. 0106]).
Regarding Claim 13, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches wherein the electrophoretic device comprises no mechanically moving parts (the device as shown in Figs.1 and 3 comprises no mechanically moving parts since the sample is driven by electric field only through electrokinetic [para. 0008]).
Regarding Claim 14, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches wherein the at least one sample loading chamber comprises a volume ranging from between about 0.1µL to about 5mL (reservoir 105 is configured to hold at least 1 µL to 500 µL of fluid [para. 0089], which is within the disclosed range).
Regarding Claim 15, modified Meller teaches the electrophoretic device of claim 14.
Meller does not explicitly teach wherein the volume of the at least one sample loading chamber ranges from between about 0.1 mL to about 1 mL.
However, Meller teaches wherein the volume of the at least one sample loading chamber ranges from 1 µL to 500 µL of fluid [para. 0089].
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the volume of the sample loading chamber of Meller to have a volume between 1 µL to 500 µL to provide external access to the microchannel [para. 0089]. 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 22, modified Meller teaches the electrophoretic device of claim 19.
Meller teaches wherein the at least one sample loading chamber includes one or more trailing electrolytes (left reservoir 105 is initially filled with a terminating electrolyte 106 [para. 0106]).
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Meller, Misawa, and Smejkal, as applied to claim 1 above, and in view of Marshall (Designing Automated Systems for Sample Preparation of Nucleic Acids Using Isotachophoresis, 2013. PhD thesis of Stanford University, pages 1-115).
Regarding Claim 7, modified Meller teaches the electrophoretic device of claim 1.
Meller is silent on further comprising one or more heating and/or cooling modules.
Marshall teaches optimization techniques for ITP (abstract), and teaches one or more heating modules (a heating package is applied below the under the microchannel [page 91-93; Figure 5-1 on page 92]).
Modified Meller and Marshall are considered analogous art to the claimed inventions because they are in the same field of ITP devices. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the ITP device of modified Meller to include a heating module, as taught by Marshall, as adding heating allows for the integration of benchtop preparation techniques, such as cell lysis, into the microfluidic platform (Marshall, [second para., page 91]).
Regarding Claim 19, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches wherein the at least one waste collection chamber and the at least one sample collection chamber are each pre-loaded with one or more electrolytes (right reservoir 108 and the remainder of the microchannel are filled with leading electrolyte 109 [para. 0106]; reservoir 121 is filled with an electrolyte solution [para. 0117]), wherein the one or more electrolytes are one or more leading electrolytes (right reservoir 108 and the remainder of the microchannel are filled with leading electrolyte 109 [para. 0106]).
Meller does not explicitly teach wherein the one or more electrolytes in the sample collection chamber are one or more leading electrolytes.
Marshall teaches wherein the one or more electrolytes in the sample collection chamber are one or more leading electrolytes (as illustrated in Figure 2-1, the ITP device is initially filled with LE buffer in the extraction reservoir [Figure 2-1 on page 40]). It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrolyte in the sample collection chamber of modified Meller to include one or more leading electrolytes, as taught by Marshall, as adding leading electrolyte in the sample collection chamber allows to successful operation of an ITP electrophoretic device (Marshall, [Figure 2-1, page 40]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Meller, Misawa, and Smejkal, as applied to claim 8 above, and in view of Snider (A Microfluidics Workflow for Sample Preparation for Next-Generation DNA Sequencing SLAS Technology 2019; 24(2), pages 196-208) and Guzman 2008 (Immunoaffinity capillary electrophoresis as a powerful strategy for the quantification of low-abundance biomarkers, drugs, and metabolites in biological matrices Electrophoresis 2008; 29(16), pages 3259-3278).
Regarding Claim 9, modified Meller teaches the electrophoretic device of claim 8.
Meller is silent on wherein the at least one sample loading chamber includes a plurality of beads, and wherein the first aperture is smaller than an average diameter of the plurality of beads within the at least one sample loading chamber.
Snider teaches a microfluidic device for amplifying DNA fragments (abstract), and teaches a plurality of beads (beads [second para. col. 2, page 198; second and third paras. page 200]) in the sample loading chamber (beads are initially added to sample loading chamber W1 [Figure 1, page 197]).
Modified Meller and Snider are considered analogous art to the claimed inventions because they are in the same field of electrophoresis devices. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sample loading chamber of modified Meller by adding beads to the sample loading chamber, as taught by Snider, as beads, such as magnetic beads, can be used to immobilize and release biomolecules like DNA for processing (Snider, [col. 2 para. 2, page 198]).
Modified Meller is silent on wherein the first aperture is smaller than an average diameter of the plurality of beads within the at least one sample loading chamber.
Guzman 2008 teaches a capillary electrophoresis instrument and analyte concentrator (abstract), and wherein the first aperture is smaller than an average diameter of the plurality of beads (beads used are smaller than the inner diameter of the capillary used to generate the analyte concentrator device, but larger than the separation capillary, trapping the beads [last para. page 10; also illustrated in Figure 1B]).
Modified Meller and Guzman 2008 are considered analogous art to the claimed inventions because they are in the same field of electrophoresis devices. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the aperture of modified Meller to be pinched so that the first aperture is smaller than an average diameter of the plurality of beads, as taught by Guzman 2008, as trapping the beads prior to the separation channel allows for sample concentration prior to the electrophoretic separation channel (Guzman 2008, [third and fourth paras., page 10; Figure 1, page 20]). In addition, as the beads of modified Meller are located in the sample collection well prior to the electrophoretic separation channel, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have the first aperture smaller than an average diameter of the plurality of beads within the at least one sample loading chamber, as this apparatus setup keeps the beads located prior to the electrophoresis separation region (see Figure 1B of Guzman 2008, page 20).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Meller, Misawa, Smejkal, Snider, and Guzman 2008, as applied to claim 9 above, and in view of Kim (Fabrication of microfluidic devices incorporating bead-based reaction and microarray-based detection system for enzymatic assay. Sensors and Actuators B 2009; 137, pages 305-312).
Regarding Claim 11, modified Meller teaches the electrophoretic device of claim 9.
Meller is silent on wherein a second portion of the wall comprises a ductal opening, and wherein the ductal opening is larger than the average diameter of the plurality of beads within the at least one sample loading chamber.
Kim teaches a microfluidic device for enzyme-based assays (abstract), and teaches a second portion of the wall comprises a ductal opening (top of the inlet port corresponds to a ductal opening [col. 1 fourth para., page 306]), and wherein the ductal opening is larger than the average diameter of the plurality of beads within the at least one sample loading chamber (70 µm microbeads were injected into the microfluidic device [col. 1 fourth para., page 306]; as illustrated in Figure 3a, glass beads are added to via inlet opening to later get trapped in reaction chamber [page 309]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sample loading chamber of modified Meller to include a second portion of the wall comprises a ductal opening, and wherein the ductal opening is larger than the average diameter of the plurality of beads within the at least one sample loading chamber, as taught by Kim, as an opening in the microfluidic device allow for beads to be added to the microfluidic device for experimental use (Kim, [as shown in Figure 3a], and the beads allow for immobilized enzyme to detect compounds, such as glucose [col. 2 fourth para., page 306]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Meller, Misawa, and Smejkal, as applied to claim 1 above, and in view of Guzman 2019 (US 2019/0331637 A1).
Regarding Claim 16, modified Meller teaches the electrophoretic device of claim 1.
Meller teaches wherein the first of the two sample collection chambers is in communication with the branched transfer conduit (as illustrated in Figure 1B, lower reservoir 121 is in communication with the branched transfer conduit).
Meller is silent on further comprising two sample collection chambers, wherein the first of the two sample collection chambers is in further communication with a second of the two sample collection chambers through an intermediate channel.
Guzman 2019 teaches an electrophoresis apparatus for analyzing multiple samples in varying concentrations (abstract), and teaches two sample collection chambers (concentrator 36 and concentrator 38 in Figure 9 [para. 0093]), wherein the first of the two sample collection chambers is in further communication with a second of the two sample collection chambers through an intermediate channel (as illustrated in Figure 9, an intermediate channel along with valve 106 to connect concentrator 36 and concentrator 38).
Modified Meller and Guzman 2019 are considered analogous art to the claimed inventions because they are in the same field of electrophoresis devices. It would have been obvious to one of ordinary skill in the art prior to modify the electrophoresis device of modified Meller by adding a second sample collection chamber, wherein the first of the two sample collection chambers is in further communication with a second of the two sample collection chambers through an intermediate channel, as taught by Guzman 2019, as adding multiple sample or concentrators allows for the collection of specific samples or controlling the microenvironment of each chamber (Guzman 2019, [para. 0093]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Meller, Misawa, and Smejkal, as applied to claim 1 above, and in view of Han (Simultaneous RNA purification and size selection using on-chip isotachophoresis with an ionic spacer. Lab Chip August 2019; 19(16), pages 2741-2749).
Regarding Claim 17, modified Meller teaches the electrophoretic device of claim 1.
Meller is silent on wherein the branched transfer channel is pre-loaded with a gel.
Han teaches a gel electrophoresis, ITP-based size-selection for extracting RNA (abstract), and teaches wherein the branched transfer channel is pre-loaded with a gel (in the TE, LE, and branch reservoirs, thermal-responsive gel is used to eliminate pressure during loading [last para. page 3]).
Modified Meller and Han are considered analogous art to the claimed inventions because they are in the same field of electrophoresis devices using ITP. It would have been obvious to one of ordinary skill in the art prior to modify the branched transfer channel of modified Meller by pre-loading with a gel, as taught by Han, as adding gel initially helps to eliminate pressure driven flow during loading (Han, [last para. page 3]).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-12, filed 05/04/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered.
Applicant’s Argument #1
Applicant argues that as independent claim 1 has been amended so that the electrophoresis device has a specific conduit geometry, not merely a generic rearrangement of reservoirs. As amended claim 1 requires that the sample loading chamber, waste collection chamber, and sample collection chamber are not only within the same layer, but are also arranged within the same plane and fluidically coupled through a branched transfer channel having a primary channel and first and second secondary channels, the single integrated topology is not taught or suggested by Meller and Misawa.
Examiner’s Response #1
Applicant argues have been fully considered, but are moot in terms of the new grounds of rejection above.
Applicant’s Argument #2
Applicant argues on pages 8-11 that the addition cited references for dependent claims 7, 9, 11, 16, 17, and 19 do not teaches the not amended claim 1 limitations.
Examiner’s Response #2
Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection above.
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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