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 Final Office Action based on application 18/027393 response filed 04/20/2026.
Claims 1-16 & 28-43 have been elected, examined and fully considered.
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, 14, 15 & 21 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.
With respect to Claim 5, it remains unclear. For the claimed “period of time,” it is unclear if applicant is selecting the period of time, since only the distance is claimed a “selected from.” The claimed period of time cannot be all of the claim options for the period of time, so it is not clear which the claim is limited to. Correction is required.
With respect to Claim 14, it depends on Claim 1, and mentions “the reservoir fluid,” which was not mentioned in Claim 1. Therefore, it is unclear what “the,” refers back to. Further as claimed in Claim 1, it is not required that aptamers be in the sensor fluid and reservoir fluid, so what applicant is referring to is confusing and unclear.
With respect to Claim 15 it is unclear what applicant means by the concentration of analyte in the sensor fluid is “selected from,” a “% concentration of analyte in the sample fluid.” It is unclear what one fluid has to do with the other in the claims, and this claiming in Claim 15 is very unclear.
With respect to Claim 21, it is unclear how a device can be “configured to retain,” over long periods of time. What is claimed in claim 1, seems to be an attempt at claiming a material property of a device, however it is not clear what if any structural or apparatus part would give the claimed functionality if so. Therefore, this claim is unclear.
Any claims that are dependent on these claims are rejected by virtue of their dependency on a rejected claim.
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 1-16, 18-36 & 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/sample fluid (para 0023-0027). WEI teaches that the sample/test sample has an unknown analyte concentration (paragraph 0056).
The device in WEI comprising aptamer-binding partner conjugate; and a binding partner for conjugating to an aptamer to generate an aptamer-binding partner conjugate(abstract).
Aptamers are synthetic receptors that adopt conformations that enable them to bind molecular analytes with high affinity and are biopolymers which are made from natural or unnatural oligonucleotides, amino acids, or hybrid structures (paragraph 0002). WEI teaches that the substrate of the instant invention is a film or nanoparticle (paragraph 0020), and that the substrate can be a plurality of nanoparticles (paragraph 0022) and further teaches that a plurality of aptamers can be used (paragraph 0034). The claimed term, “sensor fluid,” is so broad it can read on anything including aqueous buffer (paragraph 0005, 0048, 0051, 0054), which is in communication with the aptamers.
WEI teaches that the binding partner is attached to the aptamer and comprises a signaling molecules (paragraph 0010) and upon conjugation of the aptamer to the binding partner, modulates optical properties of the signaling molecule, which is further modulated when analyte is present/bound (paragraph 0011). The signaling molecule emits energy in the visible spectrum, preferably a fluorescent optical signal in the near-infrared range of 450 to 600nm or 650 to 900nm (paragraph 0017). This reads on the claimed optical tag and the configurations claimed for change of state and shape (Also see Fig. 2; para 0043, 0048, 0060-0061).
WEI further teaches of an optical source configured to emit light, the optical – source, for example can use excitation wavelength of 460 nm, and emission is detected by an optical detector from 500 to 650 nm – by a Cary Varian Eclipse fluorophotometer (paragraph 0055, 0037, 0064). WEI teaches that the detector detects a change in at least one optical property of the aptamers (para 0055, 0064, fluorescent measurements, 0027).
WEI does not specifically disclose at least one isolation element retaining the aptamer in a/the sensor fluid. It is also claimed that the optical source is in communication with the sensor fluid, though WEI makes this obvious because of the sample analytes uses and measurements taught (paragraph 0044-0045 & 0088-0055), since sensor fluid is so broad it can read on anything including aqueous buffer (paragraph 0005, 0048, 0051, 0054), in case communication in a sensor fluid is unclear, FRENZ is also used to remedy this.
FRENZ teaches of an aptamer sensing device (para 0437-0438, 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).
Specifically, FRENZ teaches of contacting the biological sample with a substrate and that in some instances the analytes diffuse through a liquid layer between a biological sample and the substrate (paragraph 0086). Here--- the liquid layer between the substrate and the sample is a liquid layer, which can read on the claimed sensor fluid, and the biological sample itself is the sample fluid which can be something like blood (paragraphs 0209-0210, 0086).
FRENZ further teaches that there is a light source 2252 which can generates light in any one or more of the ultraviolet, visible, and/or infrared regions of the electromagnetic spectrum. A variety of different light source elements can be used to generate the light, including (but not limited to) light emitting diodes, laser diodes, laser sources, fluorescent sources, incandescent sources, and glow-discharge sources (paragraph 1298), and that the light is directed on the sample (paragraph 1301). This reads on the optical source in “communication” with a sensor fluid (which is in contact with the sample fluid, through broadest reasonable interpretation, since again--- analytes in the sample fluid can diffuse through a liquid layer between a biological sample and the substrate (paragraph 0086), and the biological sample can be mixed with many other fluids such as SDS among others all, of which can be considered to the be “sensor fluid,” through broadest reasonable interpretation (paragraph 1317).
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.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to have the optical source in “communication” with a sensor fluid as taught by FRENZ in the invention of WEI due to the advantage this would have for identifying the sample components on the sensor/in the sensor fluid (FRENZ para 1242, 1297, 1304).
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). It is noted that the operation of the device, is a method limitation, so the time of operation of the device is not limiting for the claimed device.
However, 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). Further—the device as taught by WEI And FRENZ is “configured to,” detect fluorescence lifetime as claimed, however as what is instantly claimed is not a method, the actual lifetime of the detection is a methodical limitation so not limiting for the claimed device. 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). Further—the device as taught by WEI And FRENZ is “configured to,” detect response time as claimed, however as what is instantly claimed is not a method, the response time is a methodical limitation so not limiting for the claimed device
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 18, FRENZ further teaches the device of claim 3, wherein the membrane has diffusion permeability (para 0513, 0589); but does not specifically disclose an effective diffusion coefficient 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 effective diffusion 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).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). 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 adjust 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).
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
With respect to the 112 rejections, applicant has overcome most of them, however a few remain for the claims as shown in the rejections above.
With respect to the 103 rejection, it is maintained. With respect to the prior art, applicant argues that the prior art does not teach of the claimed sensor fluid, the aptamers being disposed in the senor fluid, at least one isolation element retaining the aptamer in the sensor fluid, and an optical source configured to emit light, the optical source in communication with the sensor fluid.
The examiner notes that the prior art rejection was made clearer as shown above to point out where these elements are taught as shown in the rejection above.
Specifically, it is noted that the term, “sensor fluid,” is very broad in the claim and can read on any fluid contained in or surrounding or interacting with the claimed device. It is so broad that it can read on anything including aqueous buffer (paragraph 0005, 0048, 0051, 0054), taught by WEI, which is in communication with the aptamers. WEI does not specifically disclose at least one isolation element retaining the aptamer in a/the sensor fluid. It is also claimed that the optical source is in communication with the sensor fluid, though WEI makes this obvious because of the sample analytes uses and measurements taught (paragraph 0044-0045 & 0088-0055), since sensor fluid is so broad it can read on anything including aqueous buffer (paragraph 0005, 0048, 0051, 0054), in case communication in a sensor fluid is unclear, FRENZ is also used to remedy this.
FRENZ teaches of an aptamer sensing device (para 0437-0438, 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).
Specifically, FRENZ teaches of contacting the biological sample with a substrate and that in some instances the analytes diffuse through a liquid layer between a biological sample and the substrate (paragraph 0086). Here--- the liquid layer between the substrate and the sample is a liquid layer, which can read on the claimed sensor fluid, and the biological sample itself is the sample fluid which can be something like blood (paragraphs 0209-0210, 0086).
FRENZ further teaches that there is a light source 2252 which generates light in any one or more of the ultraviolet, visible, and/or infrared regions of the electromagnetic spectrum. A variety of different light source elements can be used to generate the light, including (but not limited to) light emitting diodes, laser diodes, laser sources, fluorescent sources, incandescent sources, and glow-discharge sources (paragraph 1298), and that the light is directed on the sample (paragraph 1301). This reads on the optical source in “communication” with a sensor fluid (which is in contact with the sample fluid, through broadest reasonable interpretation, since again--- analytes in the sample fluid can diffuse through a liquid layer between a biological sample and the substrate (paragraph 0086), and the biological sample can be mixed with many other fluids such as SDS among others all, of which can be considered to the be “sensor fluid,” through broadest reasonable interpretation (paragraph 1317).
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.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to have the optical source in “communication” with a sensor fluid as taught by FRENZ in the invention of WEI due to the advantage this would have for identifying the sample components on the sensor/in the sensor fluid (FRENZ para 1242, 1297, 1304).
In response to applicant's arguments against the references individually and specifically with respect to WEI individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that WEI does not teach of an optical source. The examiner disagrees- however notes again that the rejection was made by WEI in view of FRENZ.
WEI specifically teaches of an optical source configured to emit light, the optical – source, for example can use excitation wavelength of 460 nm, and emission is detected by an optical detector from 500 to 650 nm – by a Cary Varian Eclipse fluorophotometer (paragraph 0055, 0037, 0064). WEI teaches that the detector detects a change in at least one optical property of the aptamers (para 0055, 0064, fluorescent measurements, 0027).
Applicant does not make substantive arguments about the BARANOV reference.
All claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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