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 .
Detailed Action
Summary
This is the Non-Final Office Action based on application 18/027393 election response filed 10/07/2025.
Claims 1-43 have been elected, examined and fully considered.
Election/Restrictions
Applicant’s election without traverse of Claims 1-43 in the reply filed on 03/21/2023 is acknowledged.
Claims 44-49 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/07/2025.
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 5, 7, 8, 11-15, 17-21, 25-26, 28, 31-32, & 42 and those claims dependent therefrom 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 5 recites the broad recitation “at least less than 10 nm,”, and the claim also recites, “at least less than 1nm,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. This also applies to the10%-90% limitations claimed as 10% is much broader than 90%, so it is unclear what scope applicant intends the claim to have.
For Claim 7, the same also applies to the “at least one of less than,” “5ns, 10ns, 20ns, 50ns, 100ns,” so it is unclear what scope applicant intends the claim to have.
For Claim 8, the same also applies to the “less than,” “10ns or 100ns,” so it is unclear what scope applicant intends the claim to have.
For Claims 11-13, the same also applies to the “at least one of,” “2x, 10x, 50x, or 250x,” so it is unclear what scope applicant intends the claim to have.
For Claims 14-15, the same also applies to the “at least,” “50%, 10%, 2 % , or .4%,” so it is unclear what scope applicant intends the claim to have.
For Claim 19, the same also applies to the “less than an amount selected from” “10nm, 1um, 10um, and 100um,” so it is unclear what scope applicant intends the claim to have.
For Claim 20, the same also applies to the “greater than an amount” “2x, 5x, 10x, 20x,” so it is unclear what scope applicant intends the claim to have. Further—rententivity and molecular weight are not the same thing- therefore it is unclear why they are used with a “/” to indicate that they mean the same thing.
For Claim 21, the same also applies to the “period of time selected from,” “> 16 months, > 8 months, >4 months, > 2 months, >1 month, > 2 weeks, and > 1 week,” so it is unclear what scope applicant intends the claim to have.
For Claim 25, the same also applies to the “> 15kDa, > 30kDa, >60kDa, > 120kDa,” so it is unclear what scope applicant intends the claim to have.
For Claim 26, the same also applies to the “period of time selected from,” “> 20kDa, > 10kDa, >5kDa,” so it is unclear what scope applicant intends the claim to have.
For Claim 28, the same also applies to the “> 1 nm, > 3nm, > 10nm, > 30 nm, > 100nm” so it is unclear what scope applicant intends the claim to have.
For Claim 31, the same also applies to the, “at least less than,” “180 min, 60 min, 20 min, 5 min, 2min” so it is unclear what scope applicant intends the claim to have.
For Claim 32, the same also applies to the, “at least one of less than,” “100um, 10um, 1um, 0.1um, and 0.01um” so it is unclear what scope applicant intends the claim to have.
For Claim 42, the same also applies to the, “at least,” “> 1nm, > 3nm, >10nm, > 30nm, or >100nm,” so it is unclear what scope applicant intends the claim to have.
With respect to Claim 9, “the substrate,” and “the optical detector,” fail to have proper antecedent basis as substrate and optical detector were not referred to priorly in the claims.
With respect to Claim 17, it is unclear what a fluid being “adapted to,” means. Does this means a process changes the fluid? If so- it is noted that methodical limitations are not limiting for the claimed device.
With respect to Claim 18, applicant has claimed a formula to describe a membrane, but hasn’t claimed what Deff/triangle x means. Therefore, the claim is unclear. Further--- the claimed group is unclear, since it is unclear what is any of the values mean or if they are alternatives to one another.
Claim Rejections - 35 USC § 103
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 non-obviousness.
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 1-36 & 38-43 are rejected under 35 U.S.C. 103 as being obvious over WEI in US 20190276828 in view of FRENZ in US 20200277664.
With respect to Claim 1, WEI teaches of a device for detecting the presence of, or measuring the concentration or amount of, at least one analyte in a sample fluid (para 0023-0027), the device comprising: a sensor fluid (para 0048, 0054; a plurality of aptamers disposed in the sensor fluid, one or more aptamers of the plurality of aptamers configured to bind to an analyte (para 0034, 0049, 0055), each of the one or more aptamers comprising: at least one optical tag (Fig. 1c; para 0034, 0043, 0048, fluorescent dye molecule.), wherein the optical tag is configured to provide a change in at least one optical property of the aptamer between a first state in which the aptamer is bound to the analyte and a second state in which the aptamer is not bound to the analyte, the first state and the second state differing in the shape of the aptamer (Fig. 2; para 0043, 0048, 0060-0061, aptamer binding causes a colour change in the dye as the signaling molecules undergoes a conformational change, as shown.); an optical source configured to emit light, the optical - source in communication with the sensor fluid (para 0048, 0060, 0061, dye changes color from pale yellow to bright yellow.); and an optical detector configured to detect a change in at least one optical property of the aptamers (para 0027, 0055, 0064, fluorescent measurements). WEI does not specifically disclose at least one isolation element retaining the aptamer in the sensor fluid.
However, FRENZ teaches of an aptamer sensing device (para 0007, 0894, detecting probes.), comprising a sensor substrate (para 0466), aptamer (para 0360, 0437), an optical tag (para 0177, 0391, 0617), a binding feature (para 0365, 0650, 065, 1102), and at least one isolation element retaining the aptamer in the sensor fluid (para 0292, 0293, 0466, porous membrane for attachment of capture probes).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to substitute the isolation element as taught by FRENZ and it would have been obvious for use in the sensing electrode as in WEI in order to facilitate transfer of analytes out of the sample with permeabilization of the biological samples using reagents (FRENZ para 0271, 0272), because FRENZ and WEI are directed towards sensing electrodes.
With respect to Claim 2, WEI teaches the device of claim 1 wherein, a first optical tag is a fluorescent tag configured to emit an amount of light (para 0034, 0063), and a second optical tag is a quencher configured to quench at least a portion of the light emitted by the first optical tag (para 0028, 0034, 0060, metal surface used to quench the fluorescent tag and metal- enhanced fluorescence used to detect emittance of a signal from the signaling molecules).
With respect to Claim 3, WEI teaches of the above, but not of the isolation element. FRENZ teaches the device of claim 1, wherein the isolation element is a membrane (para 0292, 0293, 0466). See reason for combination from Claim 1.
With respect to Claim 4, WEI teaches of the above, but not of the isolation element. FRENZ teaches the device of claim 1, wherein the isolation element is a hydrogel, wherein the one or more aptamers are bound to the hydrogel (para 0292, 0759). See reason for combination from Claim 1.
With respect to Claim 5, WEI teaches the device of claim 2, wherein varying distance between quencher and tag (para 0028, 0029, 0034); and teaches that the quencher is at least less than one of 10 nm, 5 nm, 2 nm, or 1 nm (it is held 1 nm, 2 nm, 3 nm, 4 nm, 5nm). WEI does not teach of the time it is held there, specifically for at least one of 10%, 20%, 40%, or 90% of the time during the operation of the device. WEI further teaches operation of the device includes switching to generate a fluorescent signal (Fig. 2; para 0060, 0061).
Further, FRENZ teaches activating and inactivating the detectable label a plurality of times (para 1348).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the distance and time would have been obvious through routine experimentation to optimize fluorescent detection for efficient and rapid detection (FRENZ, para 0365).
With respect to Claim 6, WEI teaches of the invention as shown above, but does not teach of detection of “fluorescence lifetime”. WEI does teach though of monitoring fluorescence intensity lifetime (See figure 3-4). FRENZ also teaches the device of claim 2, wherein the optical detector is configured to detect a fluorescence lifetime/cycles from the fluorescence of the light emitted by the fluorescent tag (para 0019, 0177-0178, 0392). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect fluorescence l as is done in FRENZ in the device of WEI due to (FRENZ, para 0365).
With respect to Claim 7, WEI teaches FRENZ teaches the device of claim 6, wherein a lifetime is nanoseconds (para 0365); but does not specifically disclose the fluorescence lifetime is at least one of less than 5 ns, 10 ns, 20 ns, 50 ns, and 100 ns.
However, FRENZ teaches photo-cleavable linkers that can be cleaved in nanoseconds (para 0365). To a person of ordinary skill in the art, selecting among photo-cleavable linkers would have been obvious to optimize the detection of a fluorescence (para 03414, 0366). See reason for combination from Claim 6.
With respect to Claim 8, FRENZ teaches the device of claim 6, wherein a lifetime is nanoseconds (para 0365); but does not specifically disclose that the optical detector has a response time that is less than 10 ns or less than 100 ns. Further, FRENZ teaches activating and inactivating the detectable label a plurality of times (para 1348). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the distance and time would have been obvious through routine experimentation to optimize fluorescent detection for efficient and rapid detection (WEI: para 0365).
With respect to Claim 9, FRENZ teaches the device of claim 1, wherein one or more surfaces of the optical device (para 0539), the optical detector, or the substrate that are in communication with the sensor fluid (para 0611); but does not specifically disclose that said surfaces are >50% reflective. However, FRENZ teaches of reflectivity for detection (para 0611). To a person of ordinary skill in the art, varying the reflectivity would have been obvious in order to optimize probe detection.
With respect to Claim 10, FRENZ teaches the device of claim 1, further comprising a reservoir fluid that is in fluidic communication with the sensor fluid (para 0954, 0963).
With respect to Claim 11, FRENZ teaches the device of claim 10, wherein a volume of the sensor fluid (para 0967); but does not specifically disclose a volume of the reservoir fluid is at least one of 2X, 10X, 50X, or 250X greater than a volume of the sensor fluid. However, FRENZ teaches reservoirs for use in dispensing sample fluid (para 0834, 0837) and operation use of days, months, or years (para 1332). To a person of ordinary skill in the art, varying the size of the reservoir fluid would have been obvious through routine experimentation in order to improve efficiency of analyte capture (para 0806).
With respect to Claim 12, FRENZ teaches the device of claim 10, wherein a first mass flow of aptamer through the isolation element and a second mass flow of aptamer through the fluidic connection between the sensor fluid and the reservoir fluid (para 0889, 0952, 1195); but does not specifically disclose that the first mass flow is at least 2X, 10X, 50X, or 250X less than the second mass flow. However, FRENZ teaches varying volume from two flows for use with forming droplets (para 0962, 0967).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the mass flow rates of two flows would have been obvious through routine experimentation to optimize depositing features on the substrate (para 0510). Further, “mass flow,” seems to be a methodical limitation, and this is not limiting in the claimed device.
With respect to Claim 13, FRENZ teaches the device of claim 10, wherein there is a first mass flow of analyte through the isolation element and a second mass flow of analyte through the fluidic connection between the sensor fluid and the reservoir fluid (para 0889, 0952, 1195); but does not specifically disclose that the first mass flow is at least 2X, 10X, 50X, or 250X greater than the second mass flow. However, FRENZ further teaches varying volume from two flows for use with forming droplets (para 0962, 0967). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the mass flow rates of two flows would have been obvious through routine experimentation to optimize depositing features on the substrate (para 0510). Further, “mass flow,” seems to be a methodical limitation, and this is not limiting in the claimed device.
With respect to Claim 14, FRENZ teaches the device of claim 1, further comprising a reservoir fluid that is in fluidic communication with the sensor fluid (para [0954], (0963]); but does not specifically disclose a concentration of the plurality of aptamers in the sensor fluid is within at least 50%, 10%, 2%, or 0.4% of a concentration of the plurality of aptamers in a reservoir fluid. However, FRENZ further teaches a concentration gradient of aptamers applied to the substrate (para [0545], (0548]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the concentration of aptamers would have been obvious in order to optimize the detection in regions of interest (para 0715).
With respect to Claim 15, FRENZ teaches the device of claim 1, wherein a concentration of analyte in the sensor fluid is varies (para 0952, 1195); but does not specifically disclose within at least 50%, 10%, 2%, or 0.4% of a concentration of analyte in the sample fluid. However, FRENZ further teaches droplet formation using the analyte and sample fluid (para 0962). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the amount of analyte in the sensor fluid would have been obvious to deposit features on the substrate (para 0510).
With respect to Claim 16, FRENZ teaches the device of claim 3, wherein the membrane has a backing material, and the backing material is in communication with the sample fluid (para 0292, 0293, permeable hydrogel porous membrane with probes attached on one side and sample on one side.).
With respect to Claim 17, FRENZ further teaches the device of claim 10, wherein the reservoir fluid is adapted to absorb from the sensor fluid one or more aptamers of the plurality of aptamers that have degraded or absorb from the sensor fluid any optical tag that has degraded (para 0568-0570, 0605, 0645, 0771, 0803, water and reagents are absorbed to rehydrate shrunken beads with capture agents whose outer shell comprises a dehydrated volume... degradable bead release capture agent.).
With respect to Claim 18, FRENZ further teaches the device of claim 3, wherein the membrane has diffusion permeability (para 0513, 0589); but does not specifically disclose a Deff/.delta.x that is greater than an amount selected from the group consisting of 5 m s- 1x 10-3, 0.5, 0.05 m s-1 x 10-3, and 0.005 m s-1 x 10-3. However, FRENZ further teaches varying a tunable pore volume to produce diffusion permeability and retention of entrained species (para 0589, 0986). To a person of ordinary skill in the art, varying the Deff/.delta.x would have been obvious through routine experimentation to optimize the permeability and retention of entrained species.
With respect to Claim 19, FRENZ further teaches the device of claim 3, wherein the membrane has a thickness that is less than an amount selected from the group consisting of 100 nm, 1 micrometer, 10 micrometer, and 100 micrometer (para 0291).
With respect to Claim 20, FRENZ further teaches the device of claim 3, wherein the membrane has retentivity and molecular weight (para 0291,0513, 0569, 0580); but does not specifically disclose retentitivity / molecular weight that is greater than an amount selected from the group consisting of 2X, 5X, 10X, and 20X. However, FRENZ further teaches varying a tunable pore volume to produce diffusion permeability and retention of entrained species (para 0589, 0986). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the retention and molecular weight would have been obvious through routine experimentation to optimize the permeability and retention of entrained species.
With respect to Claim 21, FRENZ further teaches the device of claim 10, wherein the initial amount of aptamers in the plurality of aptamers disposed in the sensor fluid provides an initial aptamer concentration in the sensor fluid (para 0545, 0548, 0604, [0952}); but does not specifically disclose that wherein the device is configured to retain 90% of the initial aptamer concentration in the sensor fluid for a period of time selected from the group consisting of >16 months, >8 months, >4 months, >2 months, >1 month, >2 weeks, and >1 week. However, FRENZ further teaches a period of time selected from the group consisting of >16 months, >8 months, >4 months, >2 months, >1 month, >2 weeks, and >1 week (para 1332). To a person of ordinary skill in the art, varying the initial concentration would have been obvious in order to optimize the accuracy and cost of the device according to the desired period of time (para 1065, 1361).
With respect to Claim 22, WEI further teaches the device of claim 1, wherein one or more aptamers of the plurality of aptamers each includes an active portion and an inactive portion (para 0019, 0052, 0054, metal nanoparticles attached to aptamer), but does that the inactive portion increases the total aptamer molecular weight by at least 50%. However, WEI further teaches aptamer molecular weight varies from 20 kDa to 160 kDa (para 0003) and an inactive portion of about 410 nm (para 0052). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the molecular weight of the active and inactive portions would have been obvious in order to detect target analytes (para 0021) using desired wavelengths of interest (para 0019).
With respect to Claim 23, WEI further teaches the device of claim 22, wherein the inactive portion is rigid (para 0019, 0052, 0054, Ag nanoparticles).
With respect to Claim 24, FRENZ further teaches the device of claim 22, wherein the inactive portion includes at least one-fold (para 0577, probes are folded to produce shapes that are optically detected.); but does not specifically disclose that said fold is a permanent fold. However, FRENZ further teaches permanent bonds (para 0238, 0595). To a person of ordinary skill in the art, forming a permanent fold would have been obvious to optimize the detection for multiple rounds of analysis (para 0238).
With respect to Claim 25, WEI further teaches the device of claim 3, wherein the molecular weight of aptamers is >15 kDa (para 0003); but does not specifically disclose that each aptamer of the plurality of aptamers is an amount selected from the group consisting of >15 kDa, >30 kDa, >60 kDa and >120 kDa. However, WEI further teaches aptamer molecular weight varies from 20 kDa to 160 kDa (para 0003). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the molecular weight of the aptamer would have been obvious in order to detect target analytes (para 0021).
With respect to Claim 26, WEI further teaches the device of claim 22, wherein the molecular weight of aptmers is 20 kDa (para 0003); but does not specifically disclose that the active portion has a molecular weight that is selected from the group consisting of <20 kDa, < 10 kDa, and <5 kDa. However, WEI further teaches aptamer molecular weight varies from 20 kDa to 160 kDa (para 0003). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to the molecular weight of the aptamer would have been obvious in order to detect target analytes (para 0021).
With respect to Claim 27, WEI further teaches the device of claim 3, wherein a majority of the plurality of aptamers are bound to a plurality of particles (para 0034).
With respect to Claim 28, WEI further teaches the device of claim 27, wherein the size of the particles is selected from the group consisting of >1 nm (para (0052), >3 nM, >10 nM, >30 nM (para 0052), and >100 nM in diameter.
With respect to Claim 29, WEI further teaches the device of claim 1, wherein the analyte is a small molecule (para 0021, 0028, 0059).
With respect to Claim 30, WEI further teaches the device of claim 1, wherein the analyte is a protein (para 0021).
With respect to Claim 31, FRENZ further teaches the device of claim 1, wherein the device has a use time and duration (para 1128, 1332); but does not specifically disclose a lag time and the lag times to reach 90% of sensor response is less than at least one of 180 min, 60 min, 20 min, 5 min, and 2 min. However, FRENZ further teaches repeating the detection process (para 1348). To a person of ordinary skill, in the art, varying the lag time would have been obvious through routine experimentation to optimize the amount of time between the detection process for sensing accuracy (para 1065).
With respect to Claim 32, FRENZ further teaches the device of claim 1, wherein the device further comprising a surface opposite of the isolation element that defines the sensor fluid volume and the distance between said surface and said element is at least one of less than 100 micrometer, 10 micrometer, 1 micrometer, 0.1 micrometer (para 0236), and 0.01 micrometer.
With respect to Claim 33, WEI further teaches the device of claim 1, wherein one or more aptamers of the plurality of aptamers are folded aptamers (Fig. 2; para 0043, 0060, aptamer folded on left hand side, as shown.).
With respect to Claim 34, WEI further teaches the device of claim 1, wherein one or more aptamers of the plurality of aptamers are unfolded aptamers (Fig. 2; para 0043, 0060, aptamer unfolded on right hand side, as shown.).
With respect to Claim 35, WEI further teaches the device of claim 2, wherein one or more aptamers of the plurality of aptamers are configured to bind to the analyte such that the analyte separates the fluorescent tag and a quencher (Fig. 2; para 0043, 0060, aptamer bound on right hand side with quench disrupted with large conformational change and fluorescent tag emits light.).
With respect to Claim 36, WEI further teaches the device of claim 2, wherein the fluorescent tag is an excimer dye (para 0042, 0055, fluorescent dye with excitation wavelength).
With respect to Claim 38, WEI further teaches the device of claim 1, wherein the aptamer and analyte have a size (par 0062); but does not specifically disclose that the aptamer is 10X-100X larger than the analyte. However, WEI further teaches varying the distance between aptamer and substrate (para 0029). To a person of ordinary skill in the art, varying the size of the aptamer and analyte would have been obvious in order to optimize the positioning of the dye for detection (para 0062).
With respect to Claim 39, FRENZ further teaches the device of claim 3, wherein the membrane comprises a feature (para 1179, 1213, 1218), the feature sized to permit a mass transport therethrough a surface area of the membrane (para 1179, 1213, 1218); but does not specifically disclose an area 20X smaller than a surface area of the membrane. However, FRENZ further teaches varying a tunable pore volume to produce diffusion permeability and retention of entrained species (para 0589, 0986). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the feature size would have been obvious through routine experimentation to optimize the permeability and retention of entrained species.
With respect to Claim 40, FRENZ further teaches the device of claim 3, wherein the device is configured to measure the sample fluid concentration (para 0545, 0548); but does not specifically disclose to measure 90% of the sample fluid concentration in at least <15 min. However, FRENZ further teaches a time frame and pulse duration (para 1128, 1332) and increasing signal intensity (para 0271, 0519). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to vary the measure time with increase signal intensity would have been obvious through routine experimentation in order to optimize the accuracy and cost of the device according to the desired period of time (para 1065, 1361).
With respect to Claim 41, WEI further teaches the device of claim 27, wherein the particles are selected from a group consisting of a polymer, a metal (para 0034, 0052), a carbon, and an iron-oxide.
With respect to Claim 42, WEI further teaches the device of claim 41, wherein each particle is at least >1 nm (para 0052), >3 nm, >10 nm, >30 nm (para 0052), or >100 nm in diameter.
With respect to Claim 43, FRENZ further teaches the device of claim 41, wherein the particle is a magnetic nanoparticle and the isolation element is a magnet (para 0817, 0884, 0929, 1314-1315).
Claim 37 is rejected under 35 U.S.C. 103 as being obvious over WEI in US 20190276828 in view of FRENZ in US 20200277664 and further in view of BARANOV in US 20080176334.
With respect to Claim 37, WEI and FRENZ teach of the invention as shown above. FRENZ further teaches the device of claim 3, wherein the membrane is a filter (para [0826]); but does not specifically disclose a dialysis membrane.
However, Baranov further teaches a device for detecting the presence of, or measuring the concentration or amount of (para 0025, 0132, at least one analyte in a sample fluid (para 0027, 0160), comprising an aptamer (para 0046, 0071, 0141) for use as a dialysis membrane (para 0164-0166). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the membrane as taught by BARANOV for use in the device in WEI, in view of FRENZ, due to the advantage it would offer to separate desired analytes (para 0023), improve sensitivity using simultaneous detection (para 0023), or for use with sample biopsy (para 0146), because WEI, FRENZ, and BARANOV are directed towards sensing electrodes (Baranov: para 0106, 0114, 01301).
Conclusion
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758