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 .
Response to Amendment
Applicant amendments filed 12/10/2025 have been entered. Applicant amendments overcomes the previous 112(b) rejection set forth in the Office Action mailed 06/10/2025, the previous 112(b) rejection is withdrawn.
Status of Claims
Claims 1, 4-6, 8-9, and 11-12 remain pending in the application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 8-9, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuhr (US-2002/0076714-A1) and as evidenced by Karger (US-4898658-A).
Regarding claim 1, Kuhr teaches a capillary tube, comprising:
a first section located within the capillary tube, the first section comprising a first material (Figure 1);
a first plurality of species-binding entities (probe 1) attached to the first material ([0025], Figure 1);
[0007] recites that “this invention provides a flow-through microfluidic (e.g., capillary) biosensor for detecting different target analytes (e.g., nucleic acids) in a sample after binding to their cognate “binding partners” (e.g. nucleic acids, antibodies, lectins, etc.). In general, binding partner “probes”, specific to various analytes are immobilized in different sections of a capillary channel, e.g., using photolabile biotin/avidin technology.” It is described by [0025] that Figure 1 shows a capillary based DNA-biosensor with electrochemical detection, where there are two different probe sections, where the first probe is the probe labeled on the left and the second probe is the probe on the right. It is described by [0060] that channel material is capable of binding, or being derivatized to bind, to the binding partner or a linker to the binding partner, and that the material is selected and/or modified so that it does not substantially bind to the analyte, where preferred materials also do not bind, or otherwise interact with probes in regions other than where it is desired to affix the probes. [0061] provides examples of the materials for the channel being glass, silicon, quartz or other minerals, plastic(s), ceramics, metals, paper, metalloids, semiconductive materials, cements, and the like. [0065] states that the one or more channels are provided as a capillary tube.
Therefore, there is a capillary tube that has a first section that comprises a first material (the materials listed by [0061]), where there is a plurality of species binding entities (probe 1) attached to the first material (materials listed by [0061]). The first section of the capillary tube will be defined where the first probe is.
a second section located within the capillary tube, the second section comprising a second material, wherein the second material is configured to prevent attachment of the first plurality of species-binding entities;
The capillary tube is made of a first material (materials listed from [0061]) where there is a first section that is designated by the first probe. There is a second probe within the capillary tube seen in Figure 1, where the second probe will define a second section that comprises a second material (materials listed from [0061]). The second probe (seen in Figure 1 labeled on the right) will define a second section of the capillary tube. [0108] describes the attachment of binding partners to the channel, where in the case of covalent bonding, a surface is blocked with a second compound to prevent nonspecific binding of labeled assay components. [0108] recites “Alternatively, the surface is designed such that it nonspecifically binds one component but does not significantly bind another. For example, a surface bearing a lectin such as concanavalin A will bind a carbohydrate containing compound but not a labeled protein that lacks glycosylation.” Therefore, the second probe area can be blocked to prevent binding of certain compounds such as the first probes.
a sensor (copper electrode) adjacent to at least some of the first plurality of species-binding entities (probe 1).
The copper electrode (sensor) seen Figure 1 is located at the outlet of the capillary, and will therefore be adjacent to all of the probes within the capillary tube, including the first probe (plurality of species-binding entities).
[0125] describes where the channel used in the device is a tube (e.g. a capillary electrophoresis tube), a conventional capillary electrophoresis device contains much of the ancillary plumbing, sample handing, delivery, and computer controller(s) for an “integrated” assay device, where [0153] describes that the capillary is mounted in a commercial capillary electrophoresis instrument which was used for its pressure flow and autosampler capabilities.
It is evidenced by Karger that a basic capillary electrophoretic apparatus 10 comprises a capillary tube or column 12 having ends 14 disposed in buffer solution reservoirs 16, where electrodes 18, 20 electrically connect the buffer solution reservoirs to apply a voltage across the electrodes to provide the motive force for electrophoretic migration of an analyte, and where the capillary column 12 is mounted as a constituent of the apparatus 10 (Karger; column 4 line 68, column 5 lines 1-10). As seen in Figure 1, the ends of the capillary column 12 are within their respective buffer solution reservoir 16 where inside each reservoir 16 there is either electrode 18 or 20, as such the capillary column 12 is attached to the electrodes 18 and 20.
Therefore, a conventional capillary electrophoresis device has electrodes as evidenced by Karger. Therefore, there will be electrodes attached to the capillary tube of Kuhr when it is loaded into the capillary electrophoresis instrument.
Note that the limitation “configured to apply a static electric field in the capillary tube” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kuhr and the apparatus of Kuhr is capable of applying a static electric field in the capillary tube. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kuhr (see MPEP §2114).
Regarding claim 4, Kuhr further teaches wherein the first plurality of species- binding entities comprises antibodies ([0007] see ““binding partners” (e.g. nucleic acids, antibodies, lectins, etc.)” and [0025] that describes Figure 1 where there is probe 1 for TB-specific probe and probe 2 an HIV-specific probe).
Regarding claim 5, Kuhr further teaches wherein the sensor (copper electrode) is arranged and configured to detect a change in an electric field different than the static electric field and proximate the first plurality of species-binding entities (probe 1) ([0007] see where complexed (bound) analyte is released along the length of the channel, where target-analytes are detected at a copper electrode poised downstream using sinusoidal voltammetry).
Note that the limitation “configured to detect a change in an electric field proximate the first plurality of species-binding entities.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kuhr and the apparatus of Kuhr is capable of detecting a change in an electric field different than the static electric field and proximate the first plurality of species-binding entities. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kuhr (see MPEP §2114).
The copper electrode of Kuhr is capable of detecting a change in an electric field different than the static electric field and proximate to the plurality of species-binding entities because it uses sinusoidal voltammetry, where sinusoidal voltammetry is an electrochemical detection method as stated by [0140] of Kuhr.
Regarding claim 6, Kuhr further teaches further comprising a sample, wherein the sample comprises at least one species configured to bind to the first plurality of species-binding entities (probe 1) ([0010] see preferred sample fluids for the detection of analytes, [0016] see “target analyte” is any molecule or molecules that are to be detected and/or quantified, [0078] see binding partners are selected based on targets).
Regarding claim 8, Kuhr further teaches wherein the first material is configured to release at least some of the first plurality of species-binding entities (probe 1) ([0042] see “The bound analytes are subsequently released from the binding partner, or the binding partner/analyte complex is released from the wall of the channel, into a fluid flowing through the channel.” Therefore materials [0060]-[0061] for the capillary are configured to release at least some of the species-binding entities).
Note the limitation “configured to release at least some of the first plurality of species-binding entities.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kuhr and the apparatus of Kuhr is capable of releasing at least some of the first plurality of species-binding entities. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kuhr (see MPEP §2114).
Regarding claim 9, Kuhr further teaches wherein binding of a species to the first plurality of species-binding entities (probe 1) results in release of at least some of the first plurality of species-binding entities (probe 1) from the first section ([0042] see “The bound analytes are subsequently released from the binding partner, or the binding partner/analyte complex is released from the wall of the channel, into a fluid flowing through the channel.”, [0136] see after analyte(s) in the sample are bound to the binding partner attached to the channel, they are released).
Regarding claim 11, Kuhr further teaches further comprising a third section within the capillary tube, the third section comprising a third material.
As described for claim 1 supra, the capillary tube is made of a first material (materials listed from [0061]) where there is a first section that is designated by probe 1 (probe to the left seen in Figure 1). Figure 1 further shows a second probe on the right side, where the second probe defines a second section of the capillary tube that comprises a second material (material listed from [0061]). It is described by [0008] that the invention is for detecting two or more analytes in a sample, where the device has a channel having a binding partner for each of the two or more analytes where binding partners for each of the two or more analytes are located in different regions of the channel. Further, [0009] recites “In particularly preferred devices the two or more target analytes comprise at least three, preferably at least 4, more preferably at least 5, most preferably at least 10, at least 50, at least 100, or at least 500 different analytes (and hence that many different binding partners).”
As such, the number of different analytes to be detected will dictate how many binding partner areas there will be that correspond to each of the desired analytes. Therefore, in the instance where there are three analytes to be detected, there will be three different probe areas/binding partners. Each probe area will define a section, where each of the sections will comprise a material listed by [0061] as that is the material that makes up the capillary tube.
Regarding claim 12, Kuhr further teaches comprising a second plurality of species-binding entities.
It is seen in Figure 1 that there are two probes, where each probe has binding partners. It is understood that in Figure 1 there is a second plurality of species-binding entities (probe/binding partner) on the right side.
Response to Arguments
Applicant arguments filed 12/10/2025 have been fully considered. Due to amendments filed 12/10/2025 to the claims, changing it so instead of the electrodes being associated with the capillary tube to the electrodes being attached to the capillary tube, the rejections in view of Kuhr as evidenced by Karger have been modified to address this amendment.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Young (US-5290587-A) teaches an electrophoresis system that has a control structure for affecting the rate of electroosmotic flow through a capillary tube that includes third and fourth high voltage power supplies 88 and 90 that has electrode leads 89 and 91 attached to the resistive coating of the capillary tube on either end (Young; column 4 lines 18-21, column 6 lines 6-17, Figure 1).
Ensing (US-5741639-A) teaches a device for combined bioaffinity assay and electrophoretic separation, where a capillary system has a first stage 1 for bioaffinity interaction and preconcentration of analyte molecules and a second stage 2 in which electrophoretic separation of the preconcentrated analyte molecules and subsequent detection of the separated species is accomplished, where there are electrodes for building up an electric field along the longitudinal extension of the second stage where the electrodes include thin metal rings on the inside wall of the capillary tube connected with a thin wire that extends through the capillary wall and ends in an electric coupling provided outside of the capillary tube (Ensing; abstract, column 3 lines 54-67).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796