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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2025 and 05/14/2026 have been considered by the examiner.
Claim Objections
Claims 1 and 25-26 are objected to because of the following informalities:
Claim 1, please amend “movement from the hybridization portion” to “movement from the one or more hybridization portions”.
Claim 25, please amend “wherein the magnetic sources” to “wherein the multitude of magnetic sources”.
Claim 26, please amend “wherein the magnetic sources” to “wherein the multitude of magnetic sources”.
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, 4-7, 9-14, 16, 18-19, 21-22, and 24-26 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, the limitation “the one or more hybridization chambers” lacks antecedent basis. In addition, the scope of the limitation “optionally beyond” is unclear as it is unclear how far the multitude of magnetic sources can move the magnetic bead past the hybridization portion and the redox portion. Claims 2, 4-7, 9-14, 16, 18-19, 21-22, and 24-26 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-6, 10-14, 16, 18-19, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe (US 2011/0053289 A1, provided in IDS submitted 05/14/2026).
Regarding Claim 1, Lowe teaches a system (meter 400 along with assay device 500 in Figure 2 [para. 0605]) for detecting a target analyte in a test sample (device is provided to detect an analyte in a liquid sample [para. 0422]), the system comprising:
a test sample receiving portion (inlet 510 receives a sample [para. 0607]; illustrated in Fig. 38C);
one or more hybridization portions (first channel portion 4302 contains deposited reagents including antibodies [paras. 0560-0561, 0645]; illustrated in Fig. 38C) interconnected to the test sample receiving portion (as illustrated in Fig. 38C, inlet 510 is connected to first channel portion 4302), wherein the one or more hybridization portions comprise or are capable of being loaded with:
a first antibody coupled to a magnetic bead (first reagent may comprise magnetically susceptible particles comprising a binding agent, such as an antibody, to bind to an analyte [paras. 0023, 0556]), the first antibody capable of specifically binding to the target analyte (analyte is bound to the antibody:magnetic particle complex [para. 0645]), and
a second antibody (second reagent may be another antibody capable of binding to an analyte [para. 0024]) coupled to an enzyme (second reagent may be conjugated to a second particle via an enzyme label [para. 0025]), the second antibody capable of specifically binding to the target analyte (second reagent may be another antibody capable of binding to an analyte [para. 0024]), wherein the enzyme is capable of converting a redox active molecule (as an example, glucose is a redox active enzyme substrate that serves as the redox active molecule for glucose oxidase [para. 0808]);
a redox portion (second channel 4304 contacts liquid in the second channel; second channel includes substrate for redox enzyme and a redox mediator [paras. 0570 and 0765]) interconnected to the one or more hybridization chambers (first channel portion 4302 is connected to second channel portion 4304 at a junction 4305 [para. 0528]), wherein the redox portion comprises or is capable of being loaded with a developing solution (a buffer can be used to resuspend dry reagents [para. 0765]) having the redox active molecule (second channel includes one or more reagent zones such as substrate for redox [para. 0765]);
an electrode set (electrode set includes working electrode 516w, counter electrode 516c, and reference electrode 516r [paras. 0497 and 0576]);
a potentiostat (electrochemical detector 412 [para. 0708]) for performing amperometry to obtain an electrochemical measurement based on conversion of the redox active molecule (signal may be detected amperometrically at the electrodes due to electrochemical signal from oxidation/reduction of a compound [para. 0447]).
This embodiment of Lowe does not explicitly teach a multitude of magnetic sources positioned for moving the magnetic bead in a sequential movement from the hybridization portion to the redox portion, wherein different magnetic sources of the multitude of magnetic sources are capable of being turned on and off in a desired sequence to achieve the sequential movement of the magnetic bead.
In a different embodiment, Lowe teaches a multitude of magnetic sources (multiple magnets, such as magnets 5201, 5202, and 5203 can be used to apply a magnetic field to different parts of the channel network in assay device 500 [para. 0623]; as illustrated in Fig. 47, magnets 5201, 5202, and 5203 would be attached to meter 400) positioned for moving the magnetic bead in a sequential movement from the hybridization portion to the redox portion (magnets move magnetic particles from reagent zone 512 to detection zone [paras. 0623-0624]), wherein different magnetic sources of the multitude of magnetic sources are capable of being turned on and off in a desired sequence to achieve the sequential movement of the magnetic bead (magnets can be switched on/off in sequence to control the positioning of the magnetic particles [para. 0862]).
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 system of Lowe to include a multitude of magnetic sources positioned for moving the magnetic bead in a sequential movement from the hybridization portion to the redox portion, wherein different magnetic sources of the multitude of magnetic sources are capable of being turned on and off in a desired sequence to achieve the sequential movement of the magnetic bead, as taught by Lowe, as movable magnetic sources can be reoriented to allow the magnetic particles to travel in the system (Lowe, [para. 0624]).
Regarding Claim 2, Lowe teaches the system of claim 1.
Lowe teaches comprising: a cartridge or a strip (assay device includes a cartridge or test strip [para. 0330]) that is insertable and removable from a device (as illustrated in Fig. 2, assay device 500 can be inserted or removed into meter 400 [para. 0605]), the cartridge or strip comprising the test sample receiving portion, the one or more hybridization portions, the redox portion, and the electrode set (cartridge or strip includes the microfluidic network, which includes the test sample receiving portion, the one or more hybridization portions, and the redox portion, along with the electrode set [para. 0606]; illustrated in the plan view in Figs. 39 and 40); and
the device comprising the potentiostat (meter 400 includes an electrochemical detector 412 [para. 0708]) and the multitude of magnetic sources (as outlined in the Claim 1 rejection above, magnets 5201, 5202, and 5203 are attached to meter 400).
Regarding Claim 4, Lowe teaches the system of claim 2.
teaches comprising the cartridge, wherein the cartridge comprises:
a port or receptacle as the test sample receiving portion (test strip 201 includes base 213, lid 214, and spacers 215 that form a port [para. 0816]);
one or more hybridization chambers as the one or more hybridization portions (first channel portion 4302 contains deposited reagents including antibodies [paras. 0560-0561, 0645]), interconnected to the port or receptacle by a first passage (liquid sample is drawn into the reagent zone 512 [para. 0645]);
a redox chamber (second channel 4304 contacts liquid in the second channel; second channel includes substrate for redox enzyme and a redox mediator [paras. 0570 and 0765]) as the redox portion interconnected to the one or more hybridization chambers by a second passage (first channel portion 4302 is connected to second channel portion 4304 at a junction 4305 [para. 0528]); and
the electrode set (electrode set 516 is positioned in the second channel portion 4304 [para. 0576]).
Regarding Claim 5, Lowe teaches the system of claim 4.
In this embodiment, Lowe does not explicitly teach wherein the cartridge further comprises one or more valves capable of being opened and closed, the one or more valves located within the first passage, the second passage, or both.
In another embodiment, Lowe teaches wherein the cartridge further comprises one or more valves (fusable vent 110 [para. 0807]) capable of being opened and closed (vent acts to prevent or promote the flow of fluid [para. 0807]), the one or more valves located within the first passage, the second passage, or both (fusable vent 110 is coupled between the first channel 104 and the second channel 105 [para. 0807]).
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 cartridge of Lowe to include one or more valves capable of being opened and closed, the one or more valves located within the first passage, the second passage, or both, as taught by Lowe, as vents may prevent or promote fluid flow across the microfluidic channels (Lowe, [para. 0807]).
Regarding Claim 6, Lowe teaches the system of claim 4.
Lowe teaches wherein the first passage, the second passage, or both, is a microchannel (a device may be a microfluidic device [para. 0057], first channel and second channel are microchannels).
Regarding Claim 10, Lowe teaches the system of claim 1.
Lowe teaches wherein the one or more hybridization portions comprise:
a first hybridization portion (first hybridization portion corresponds to a first reagent deposit 4601 of first channel portion 4302 [para. 0561]) interconnected to the test sample receiving portion (as illustrated in Figure 41, first channel portion 4302 is connected to the sample receiving portion) and comprising or capable of being loaded with the first antibody (first reagent deposit 4601 may include the first antibody attached to the magnetic particle [para. 0561]); and
a second hybridization portion (second hybridization portion corresponds to a second reagent deposit 4602 [para. 0561]) interconnected downstream to the first hybridization portion (second reagent deposit 4602 is deposited after the first reagent deposit 4601 [para. 0561]) and comprising or capable of being loaded with the second antibody (second reagent deposit 4602 may be loaded with the enzyme-label [para. 0562]).
Regarding Claim 11, Lowe teaches the system of claim 1.
Lowe teaches further comprises a washing portion (interface zone 522 includes corner 536 along with overflow channel 524 to form a washing portion [paras. 0509, 0656]; illustrated in Figure 38C) positioned between the one or more hybridization portions and the redox portion (interface zone 522 is located between the first and second channels to wash non-magnetic material away [para. 0656]; illustrated in Figure 38C), the washing portion comprising or capable of being loaded with a washing solution (washing portion is loaded with a buffer solution used in washing [paras. 0656 and 0697]).
Regarding Claim 12, Lowe teaches the system of claim 4.
Lowe teaches further comprises a washing portion (interface zone 522 includes corner 536 along with overflow channel 524 to form a washing portion [paras. 0509, 0656]; illustrated in Figure 38C) positioned along the second passage between the one or more hybridization portions and the redox (interface zone 522 is located between the first and second channels to wash non-magnetic material away [para. 0656]; illustrated in Figure 38C), the washing portion comprising or capable of being loaded with a washing solution (washing portion is loaded with a buffer solution used in washing [paras. 0656 and 0697]).
Regarding Claim 13, Lowe teaches the system of claim 12.
Lowe teaches wherein the washing portion is a washing chamber (as illustrated in Figure 38C, the interface of corner 536 and overflow channel 524 forms a chamber for washing).
Regarding Claim 14, Lowe teaches the system of claim 11.
Lowe teaches wherein the washing solution is contained in a washing pouch or blister (a reservoir, such as reservoir 507, contains a buffer liquid [para. 0647]) capable of being pierced to release the washing solution into or onto the washing portion (reservoir 507 is punctured to allow buffer liquid to flow to the junction between the first and second channel [para. 0647]).
Regarding Claim 16, Lowe teaches the system of claim 1.
Lowe teaches wherein the developing solution is contained in a developing pouch or blister (a reservoir, such as reservoir 507, contains a buffer liquid [para. 0647]; the Examiner notes that the buffer solution serves as both the developing solution and the washing solution) capable of being pierced to release the developing solution into or onto the redox portion (reservoir 507 is punctured to allow buffer liquid to flow to the junction between the first channel 4302 and second channel 4304 [para. 0647]).
Regarding Claim 18, Lowe teaches the system of claim 2.
Lowe teaches wherein the device comprises one or more piercing components (sharp projection 3506 punctures a wall [para. 0647]).
Regarding Claim 19, Lowe teaches the system of claim 1.
Lowe teaches wherein the test sample receiving portion comprises a size selective mesh for capturing cells or molecules larger than a defined size (assay device can be supplied with a blood separation membrane arranged between the sample inlet and detection zone [para. 0342]).
Regarding Claim 22, Lowe teaches the system of claim 1.
Lowe teaches wherein the electrode set comprises a three-electrode cell (electrode set comprises three electrodes 516w, 516c, and 516r [para. 0576]), and the three-electrode cell comprises a reference electrode (reference electrode 516r [para. 0576]), a counter electrode (counter electrode is 516c [para. 0576]), and a working electrode (working electrode is 516w [para. 0576]).
Regarding Claim 24, Lowe teaches the system of claim 22.
Lowe teaches wherein the working electrode and the counter electrode are comprised of a carbon ink (electrode can be screen-printed with carbon ink [para. 0884]), the reference electrode is comprised of Ag or AgCl (reference electrode is an Ag/AgCl reference electrode [para. 0576]).
Regarding Claim 25, Lowe teaches the system of claim 1.
This embodiment of Lowe does not explicitly teach wherein the magnetic sources are electromagnets.
In a different embodiment, Lowe teaches wherein the magnetic sources are electromagnets (in an embodiment, electromagnets may be used instead of permanent magnets [para. 0862]).
It would be obvious to one or ordinary skill in the art prior to the effective filing date of the claimed invention to modify the magnetic sources of Lowe to be electromagnets, as taught by Lowe, as electromagnets can be used instead of permanent magnets to control the positioning of the magnetic particles.
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe, as applied to claims 1 and 2 above, and in view of Moyana (Magnetic Lateral Flow Immunoassays Diagnostics 2020; 10 (288), 1-22).
Regarding Claim 7, Lowe teaches the system of claim 2.
Lowe is silent on wherein the strip comprises an absorbent pad as the test sample receiving portion.
Moyana teaches the strip comprises an absorbent pad as the test sample receiving portion (sample pad [first para. page 2]; also illustrated in Fig. 1 on page 2).
Lowe and Moyana are considered analogous to the claimed invention because they are in the same field of magnetic nanoparticle immunoassays. 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 strip of Lowe to comprise an absorbent pad as the test strip receiving portion, as taught by Moyana, as using absorbent pads enables the flow of sample and get robustness (Moyana, [first para. page 2]).
Regarding Claim 21, Lowe teaches the system of claim 1.
Lowe is silent on wherein the test sample receiving portion or the one or more hybridization portions comprise an absorbent pad for absorbing a fluid and transferring it into the one or more hybridization portions.
Moyana teaches wherein the test sample receiving portion comprise an absorbent pad for absorbing a fluid and transferring it into the one or more hybridization portions (sample pad [first para. page 2]; as illustrated in Figure 1, sample pad takes fluid and transfers the fluid to the hybridization portion).
Lowe and Moyana are considered analogous to the claimed invention because they are in the same field of magnetic nanoparticle immunoassays. 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 strip of Lowe wherein the test sample receiving portion comprise an absorbent pad for absorbing a fluid and transferring it into the one or more hybridization portions, as taught by Moyana, as using absorbent pads enables the flow of sample and get robustness (Moyana, [first para. page 2]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe, as applied to claim 1 above, and in view of Battrell (US 2009/0181411 A1).
Regarding Claim 9, Lowe teaches the system of claim 1.
Lowe is silent on wherein the first antibody and/or the second antibody are in a hybridization solution, and the hybridization solution is contained in a hybridization pouch or blister capable of being pierced to release the hybridization solution into or onto the one or more hybridization portions.
Battrell teaches microfluidic methods and devices for heterogeneous binding and agglutination assays (abstract), and teaches wherein the first antibody and/or the second antibody are in a hybridization solution (reagent is premeasured into a blister pouch [para. 0124], such as antibody reagents, may be safely stored in on-board blister pouches [para. 0125]), and the hybridization solution is contained in a hybridization pouch or blister capable of being pierced to release the hybridization solution into or onto the one or more hybridization portions (a sharp located near the blister pouch is contacted with the blister pouch to release the blister pouch’s contents into the microchannel [para. 0124]).
Lowe and Battrell are considered analogous art to the claimed invention because they are in the same field of microfluidic binding assays. 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 first antibody and/or the second antibody of Lowe to be in a hybridization solution, and the hybridization solution is contained in a hybridization pouch or blister capable of being pierced to release the hybridization solution into or onto the one or more hybridization portions, as taught by Battrell, as blister packs allows for reagents to be premeasured and to be safely stored on the device (Battrell, [paras. 0124-0125]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe, as applied to claim 1 above, and in view of Monticelli (On-Chip Magnetic Platform for Single-Particle Manipulation with Integrated Electrical Feedback. Small 2016; 12(7), 921-929).
Regarding Claim 26, Lowe teaches the system of claim 1.
Lowe is silent on wherein the magnetic sources are positioned in a zig zag pattern along a path of the sequential movement.
Monticelli teaches an apparatus of moving magnetic particles (abstract), and teaches wherein the magnetic sources are positioned in a zig zag pattern along a path of the sequential movement (a zig zag magnetic conduit geometry [Figure 1d on page 923] is used to move a magnetic particle along a path [first para. col. 2, page 922]).
Lowe and Monticelli are considered analogous art to the claimed invention because they are in the same field of magnetic nanoparticle immunoassays. 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 magnetic sources of Lowe to be positioned in a zig zag pattern along a path of the sequential movement, as taught by Monticelli, as using magnets in
various pattens allows for movement of magnetic particles in biosensors (Monticelli, [first para. col. 2, page 921]).
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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