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 17/880676 RCE response filed 05/25/2026.
Claims 1-20 have been examined and fully considered.
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 1-15 are rejected under 35 U.S.C. 103 as being obvious over RIEDO in US 20250208090 in view of in view of HUANG in US 20180203006.
With respect to Claims 1, 9 RIEDO teaches of a method of detecting the presence of an analyte (target material),
comprising providing a field effect transistor (FET)(abstract). RIEDO teaches that a plurality of FETS are provided in a sensor array as part of an integrated circuit (paragraph 0008, 0139-0142).
More specifically RIEDO teaches of provided the integrated devices so that it is functionalized with a plurality of different capture molecules (different probes as claimed), so that the device can/could be configured for the detection of a plurality of different analytes (as claimed, target molecules).
RIEDO teaches that some of the FETS, do not comprise capture molecules/probes and instead are configured for differential (or calibration detection) (paragraph 0008, 0014, 0048, 0134).
Though RIEDO teaches that the device can be configured to detect a plurality of different analytes (target molecules) (paragraph 0008)--- the sample itself, which can be a fluid or air (paragraph 0011), but the analyte (target molecule), will be whatever is detected by the device--- which depends on what is in the sample. RIEDO teaches that the target analyte can be coronavirus, influenza, or Ebola among other things (paragraph 0012), but even if there are different probes for all of these analytes on the FETS, if there is only one of the targets, present, only one will be detection and then the sample fluid will have “only one type of target material,” as instantly claimed. )--- however would still would only detect 1 if one is present. For example, RIEDO teaches that the device can detect SARS-COV-2 (paragraphs 0115-0116), and or could detect influenza (paragraph 0112), however the device would only detect what is actually present, which could be one or both or more than one type of viral particle (paragraph 0112, 0111).
RIEDO teaches that the device is formed by producing surface activated functional groups, which are put on the surface by a stimulus(paragraph 0009, 0005, 0007, 0009, 0010, 0046, 0047).
More specifically with respect to the claimed steps--- RIEDO teaches of providing the multiple 1st to Nth, bioFETS that are coated with different probes (paragraph 0011, 0012) (paragraph 0008, 0014, 0048, 0134, 0139-0142),
Performing differential/calibrative measurements to the 1st to Nth assay (paragraph 0008, 0014, 0048, 0134),
Applying the sample—which in this case can be air or saliva and will have whichever type or amount of targets the sample has (paragraph 0011),
performing the biosensing using the biosensing integrated circuit(paragraph 0011, 0012),
comparing the biosensing test to the differential tests (paragraph 0008, 0014, 0048, 0134), and marking/diagnosing the patient as having a specific analyte(one target)/associated disease, for example when a SARS/Cov2 antigen specific aptamer of the bioFET binds to it (paragraph 0115-0116), thereby identifying the only one type of target material, as claimed.
Though RIEDO teaches of calibrating as shown above, they do not specifically point out that calibration is performed distinctly for all of the 1st to Nth assays/FET circuit sensors, HUANG is used to remedy this. Further for Claim 16, RIEDO does not teach of coating the probes onto the detection/pixel surface, since RIEDO does not teach that the bioFET comprises a pixel. HUANG is also used to remedy this. RIEDO also does not teach of, “at least one of the 1st to the Nth assay is not marked as the binding assay,” though this is made obvious.
HUANG teaches of a sensor array and that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total). HUANG even further teaches that each FET sensor is arranged as an array of pixels (paragraph 0067), and that DNA probes (which are an example of capture reagent used on the FETs) are bound/coated to the interface layer on the FET (paragraph 0127, 0124, 0122).
HUANG further teaches that the capture reagent can be more than one type of thing which reads on first probe and second probe (paragraph 0033, 0078). HUANG teaches that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total), and that the plurality of FETS may be functionalized with the same or different capture reagents to perform the biosensing of various analytes (paragraph 0078). Even further—HUANG teaches that that the “detection,” of the instant invention can be either determining the presence OR the absence of a target analyte or analytes based on binding or lack of binding to one of the plurality of FETS (paragraph 0038, 0035-0037, 0006). Therefore, this reads on “marking,”/determining/detecting of one of the plurality of assays as not a binding assay when there is an absences of the target analyte, and marking/detecting other assays as binding--- through broadest reasonable interpretation of the term “marking.”
HUANG also teaches of a method of using a fluidic cartridge. The fluidic cartridge includes a substrate having a plurality of contact pads designed to electrically couple with an analyzer and a semiconductor chip having a sensor array, and a reference electrode (abstract).
HUANG even further teaches of needing to calibrate specifically the sensor, “array,” meaning the plurality of sensors are calibrated (paragraph 0115). HUANG teaches that the FETS are biofunctionalized (paragraph 0057), and that each FET in the array can be functionalized differently to perform biosensing for different analytes (paragraph 0078, 0101, 0110) and further that many different assays can be performed and used with these FET sensors (paragraph 0031-0034). Therefore- the teaching of calibration of the “sensor array,” in paragraph 0115 reads on calibrating the 1st -Nth assay as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of calibrate all assays and sensors of the sensor array as is done in HUANG in the method of RIEDO due to the advantage calibrating all sensors/assays has for achieving a clearer detection signal (HUANG, paragraph 0115). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of use(ing) a pixelated sensor with probes bound to the FET due to the advantage pixels have for sensing/detecting in that each pixel is individually addressable for detection/sensing and the advantage the capture reagents/probes have for performing biosensing of various analytes (HUANG, paragraphs 0066-0067, 0078). When there is absence, there is no binding.
Even further--- it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success in “marking,” as assay as “not,” “binding,”/detecting the absence of biomarkers as is done in HUANG in the method of SINHA due to the advantage the FETS in HUANG offer for label-free operation/detection of absence or presence of analytes and due to the advantage that this has for the identification of presence of diseases such as cancer (HUANG, paragraph 0058, 0027, 0038, 0034, 0044).
With respect to Claim 2, RIEDO teaches that the circuit contains bioFETS (paragraph 0002, 0044) and also sensing pixels (paragraph 014), however does not make clear pixels in an array on the bioFET.
HUANG is used to remedy this. HUANG teaches of the invention as shown above and further teaches that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total). HUANG even further teaches that each FET sensor is arranged as an array of pixels (paragraph 0067). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a pixelated sensor with the FET of HUANG in the device of RIEDO due to the advantage pixels have for sensing/detecting in that each pixel is individually addressable for detection/sensing (HUANG, paragraphs 0066-0067).
With respect to Claim 3, RIEDO teaches of the invention as shown above, but not the coating of probe/pixel association.
HUANG teaches of the probe sensors utilizing probe DNA (paragraphs 0122, 0124) and further of the FETS being arranged in pixels, reads on “coated,” in pixels through broadest reasonable interpretation (paragraph 0066, 0069, Figure 4).
It would have been obvious to one of ordinary skill in the art to coat in pixels as is done in HUANG in the method of RIEDO FET due to the advantage pixels have for sensing/detecting in that each pixel is individually addressable for detection/sensing (HUANG, paragraphs 0066-0067).
With respect to Claims 4-6, 10-12, RIEDO teaches of the device containing multiple including 4 bioFETs (paragraph 0008) and that they contain source, drain and gate electrodes (paragraph 0046). RIEDO teaches of applying voltage to a source and also to a drain electrode and when the test solution is placed on the sensor as a gate pulse is turned on, measuring potential drop in the solution and the changing conductivity and of recording the signals with a semiconductor analyzer (paragraph 0130, 0140). SINHA further teaches of measuring and applying currents (paragraph 0136). RIEDO does not teach that the bioFET, and specifically that all of the measurements are of currents between the source and drain, or at each pixel.
HUANG is used to remedy this. HUANG teaches of the invention as shown above and further teaches that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total). HUANG further teaches of making measurements for all 4 FETS/assays and the calibration between the source/drain (paragraph 0059-0061, 0057, 0070-0072, 0076) and of comparing measured and calibrated source and drain current (paragraph 0120). It would have been obvious to measure current between the source and drain as in HUANG in the method of RIEDO as this is shown to be able to aid in biorecognition (HUANG, paragraph 0057).
With respect to Claim 7, 14, RIEDO teaches of making sequential measurements (paragraph 0126).
With respect to Claim 8, 15, RIEDO teaches of having parallel sensors for simultaneous measurements (paragraph 0126).
With respect to Claim 13, RIEDO teaches that the FETS are integrated on the same chip /cartridges (paragraph 0008, 0048).
Claims 16 & 19-20 are rejected under 35 U.S.C. 103 as being obvious over RIEDO in US 20250208090 in view of in view of HUANG in US 20180203006 and further in view of LEE in US 20200182864.
With respect to Claim 16, RIEDO teaches of a method of detecting the presence of an analyte (target material),
comprising providing a field effect transistor (FET)(abstract). RIEDO teaches that a plurality of FETS are provided in a sensor array as part of an integrated circuit (paragraph 0008, 0139-0142).
More specifically RIEDO teaches of provided the integrated devices so that it is functionalized with a plurality of different capture molecules (different probes as claimed), so that the device can/could be configured for the detection of a plurality of different analytes (as claimed, target molecules).
RIEDO teaches that some of the FETS, do not comprise capture molecules/probes and instead are configured for differential (or calibration detection) (paragraph 0008, 0014, 0048, 0134).
Though RIEDO teaches that the device can be configured to detect a plurality of different analytes (target molecules) (paragraph 0008)--- the sample itself, which can be a fluid or air (paragraph 0011), but the analyte (target molecule), will be whatever is detected by the device--- which depends on what is in the sample. RIEDO teaches that the target analyte can be coronavirus, influenza, or Ebola among other things (paragraph 0012), but even if there are different probes for all of these analytes on the FETS, if there is only one of the targets, present, only one will be detection and then the sample fluid will have “only one type of target material,” as instantly claimed. )--- however would still would only detect 1 if one is present. For example, RIEDO teaches that the device can detect SARS-COV-2 (paragraphs 0115-0116), and or could detect influenza (paragraph 0112), however the device would only detect what is actually present, which could be one or both or more than one type of viral particle (paragraph 0112, 0111).
RIEDO teaches that the device is formed by producing surface activated functional groups, which are put on the surface by a stimulus(paragraph 0009, 0005, 0007, 0009, 0010, 0046, 0047).
More specifically with respect to the claimed steps--- RIEDO teaches of providing the multiple 1st to Nth, bioFETS that are coated with different probes (paragraph 0011, 0012) (paragraph 0008, 0014, 0048, 0134, 0139-0142),
Performing differential/calibrative measurements to the 1st to Nth assay (paragraph 0008, 0014, 0048, 0134),
Applying the sample—which in this case can be air or saliva and will have whichever type or amount of targets the sample has (paragraph 0011),
performing the biosensing using the biosensing integrated circuit(paragraph 0011, 0012),
comparing the biosensing test to the differential tests (paragraph 0008, 0014, 0048, 0134), and marking/diagnosing the patient as having a specific analyte(one target)/associated disease, for example when a SARS/Cov2 antigen specific aptamer of the bioFET binds to it (paragraph 0115-0116), thereby identifying the only one type of target material, as claimed.
Though RIEDO teaches of calibrating as shown above, they do not specifically point out that calibration is performed distinctly for all of the 1st to Nth assays/FET circuit sensors, HUANG is used to remedy this. Further for Claim 16, RIEDO does not teach of coating the probes onto the detection/pixel surface, since RIEDO does not teach that the bioFET comprises a pixel. HUANG is also used to remedy this. RIEDO also does not teach of, “at least one of the 1st to the Nth assay is not marked as the binding assay,” though this is made obvious.
HUANG teaches of a sensor array and that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total). HUANG even further teaches that each FET sensor is arranged as an array of pixels (paragraph 0067), and that DNA probes (which are an example of capture reagent used on the FETs) are bound/coated to the interface layer on the FET (paragraph 0127, 0124, 0122).
HUANG further teaches that the capture reagent can be more than one type of thing which reads on first probe and second probe (paragraph 0033, 0078). HUANG teaches that the sensor array is a plurality of bioFETS (paragraph 0027, 0064 and see Figure 3, FETs 302 and 304- there are 4 total), and that the plurality of FETS may be functionalized with the same or different capture reagents to perform the biosensing of various analytes (paragraph 0078). Even further—HUANG teaches that that the “detection,” of the instant invention can be either determining the presence OR the absence of a target analyte or analytes based on binding or lack of binding to one of the plurality of FETS (paragraph 0038, 0035-0037, 0006). Therefore, this reads on “marking,”/determining/detecting of one of the plurality of assays as not a binding assay when there is an absences of the target analyte, and marking/detecting other assays as binding--- through broadest reasonable interpretation of the term “marking.”
HUANG also teaches of a method of using a fluidic cartridge. The fluidic cartridge includes a substrate having a plurality of contact pads designed to electrically couple with an analyzer and a semiconductor chip having a sensor array, and a reference electrode (abstract).
HUANG even further teaches of needing to calibrate specifically the sensor, “array,” meaning the plurality of sensors are calibrated (paragraph 0115). HUANG teaches that the FETS are biofunctionalized (paragraph 0057), and that each FET in the array can be functionalized differently to perform biosensing for different analytes (paragraph 0078, 0101, 0110) and further that many different assays can be performed and used with these FET sensors (paragraph 0031-0034). Therefore- the teaching of calibration of the “sensor array,” in paragraph 0115 reads on calibrating the 1st -Nth assay as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of calibrate all assays and sensors of the sensor array as is done in HUANG in the method of RIEDO due to the advantage calibrating all sensors/assays has for achieving a clearer detection signal (HUANG, paragraph 0115). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of use(ing) a pixelated sensor with probes bound to the FET due to the advantage pixels have for sensing/detecting in that each pixel is individually addressable for detection/sensing and the advantage the capture reagents/probes have for performing biosensing of various analytes (HUANG, paragraphs 0066-0067, 0078). When there is absence, there is no binding.
Even further--- it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success in “marking,” as assay as “not,” “binding,”/detecting the absence of biomarkers as is done in HUANG in the method of SINHA due to the advantage the FETS in HUANG offer for label-free operation/detection of absence or presence of analytes and due to the advantage that this has for the identification of presence of diseases such as cancer (HUANG, paragraph 0058, 0027, 0038, 0034, 0044).
RIEDO and HUANG do not teach of coating the surface with a probe using a surface activation gas for Claim 16.
LEE is used to remedy this and teaches of a diagnostic biochip with sensors(abstract). LEE more specifically teaches that the sensors on the device (which electrical probes) are surface activated using nitrogen gas (paragraph 0111, 0117).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to surface activate with a surface activation gas as is done in LEE in the methods of RIEDO and HUANG due to the advantage that this offers in activating the surface of the sensor (LEE, paragraphs 0111, 0117).
With respect to Claim 19, RIEDO teaches of the above, but does not teach of the calibration as claimed in Claim 19. HUANG is used to remedy this and teaches of needing to calibrate specifically the sensor, “array,” meaning the plurality of sensors (paragraph 0115). HUANG teaches that the FETS are biofunctionalized (paragraph 0057), and that each FET in the array can be functionalized differently to perform biosensing for different analytes (paragraph 0078, 0101, 0110) and further that many different assays can be performed and used with these FET sensors (paragraph 0031-0034). Therefore- the teaching of calibration of the “sensor array,” in paragraph 0115 reads on calibrating the 1st -Nth assay as claimed, at the same time and reads on performing calibration of multiple assays at once. See reason for combination from Claim 1.
Further it would be obvious to instead perform operations of calibrating one by one for the multiple sensors and obtain measurements in a sequential order, since this is just a change of order of process steps while still making the same measurements/performing the same analysis. See MPEP 2144, Change in size, shape, or sequence of adding ingredients- In re Burnhans--selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results.
With respect to Claim 20, RIEDO teaches of the above, but does not teach of the calibration as claimed in Claim 20. HUANG is used to remedy this and teaches of needing to calibrate specifically the sensor, “array,” meaning the plurality of sensors (paragraph 0115). HUANG teaches that the FETS are biofunctionalized (paragraph 0057), and that each FET in the array can be functionalized differently to perform biosensing for different analytes (paragraph 0078, 0101, 0110) and further that many different assays can be performed and used with these FET sensors (paragraph 0031-0034). Therefore- the teaching of calibration of the “sensor array,” in paragraph 0115 reads on calibrating the 1st -Nth assay as claimed, at the same time and reads on performing calibration of multiple assays at once. See reason for combination from Claim 1 & 19.
Claims 17-18 are rejected under 35 U.S.C. 103 as being obvious over RIEDO in US 20250208090 in view of HUANG in US 20180203006 and further in view of LEE in US 20200182864 and further in view of RAM in US 20160290957.
With respect to Claim 17, RIEDO and HUANG and LEE teach of the claimed invention as shown above. HUANG further teaches of activating the gates of the sensors (performing surface activation) the FET sensors in the array (paragraph 0107).
RIEDO and HUANG and LEE do not teach of the claimed placing of a first and second mask layer.
RAM is used to remedy this. RAM teaches of nanoelectronic devices (paragraph 0001), which are FET sensors (paragraphs 0085-0097). RAM further teaches that each electrical circuit element is defined as a “pixel” (abstract). Even further, RAM teaches of using masks on multiple sensor elements/pixels (so this reads on the claimed first and second masking) (paragraph 0121, Figure 6, paragraph 0120). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of use(ing) the masking process as is done in RAM in the methods of RIEDO and HUANG and LEE due to the advantage it has for growing self-aligned regions of SINW (RAM, paragraph 0084).
With respect to Claim 18, RIEDO and HUANG teach of the claimed invention as shown above. HUANG teaches of activating the gates of the sensors (performing surface activation) the FET sensors in the array (paragraph 0107). This is a teaching of performing multiple activations at once, simultaneously or globally as claimed. See reason for combination from Claim 17.
Response to Arguments
Applicant's arguments filed 01/19/2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the grounds of rejection and most notably the primary reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that with respect to applicant’s argument that the sample fluid, has “only one type of target material,” that some times sample fluids only have one type, sometimes they have more than one. Though a device is capable of detecting multiple target materials still allows it to detect “only one type,” as instantly claimed, so this instant claims are made obvious.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SINHA in An integrated microfluidic system with field-effect transistor sensor arrays for detecting multiple cardiovascular biomarkers from clinical samples
SINHA teaches of a method of identifying a target material, which is multiple cardiovascular biomarkers (title).
SINHA teaches that four cardiovascular disease (CVDs) biomarkers, C-reactive protein (CRP), N-terminal pro b-type natriuretic peptide (NTproBNP), cardiac troponin I (cTnI), and fibrinogen- were analyzed from clinical samples on an integrated microfluidic platform (integrated circuit) (equipped with 1) immobilized highly specific aptamer probes and 2) field-effect transistor (FET)-based sensor arrays (abstract).
SINHA teach that they system uses four highly specific aptamers as probes (Page 161, column 2, lines 5-6) and specifically that the probes are specific to biomarkers that are diagnostic for life-threatening illnesses (Page 161, column 2, last 2 lines & Table 1).
SINHA further teaches that the microfluidic chip consists of several microfluidic devices and four field-effect transistor (FET)/detection chambers (these four FETS are the claimed “sensor array,” “divided into a 1st to Nth assay”) (FET # A, B, C, D are four aptamer probes specific to each of the four protein biomarkers, so the four probes for assays 1-4, which reads on 1st to Nth assay are coated with different aptamer probes as claimed) (See Figure 1, description- c.).
SINHA further teaches that a calibration curve is developed/formed through analysis from the FET sensor arrays, and which is specific to CRP, NT-proBNP, cTnl, and fibrinogen (abstract & Page 157, column 1, paragraph 1, line 2). SINHA teaches of comparing the test results to a pre-calibrated chip (that has the same FET sensors), and thereby interpreting concentration values of the biomarkers (Page 161, Figure 5, bottom description, & Column 1, last line). This reads on the instant claiming of “performing calibration on the 1st to Nth assay to obtain a...pretest measurement.”
SINHA even further teaches of selecting of FET detection units (FET# A, B, C, D) (j-k) by the controller ( in that more than one FET of A, B, C, and D can be selected, “FET detection units,”) (Figure 5 description) and initiating the fluidic transport/applying a sample fluid containing the protein analytes to the FET integrated microfluidic chip at step c-1 of the process, capturing the protein analytes by the surface immobilized aptamers on the FET surface at step d-1, and then elution at step e-1 (Page 159, Figure 2 description). SINHA even further teaches that the FET device is used to “quantify CVS biomarkers from markedly more complex patient clinical samples (Page 159, 3.4), and further that the instant device “detects four CVDs protein biomarkers (on the 4 differently labeled FETS,) from a single clinical sample (Page 161, column 2, 4. 8 & 9 lines from the bottom). SINHA further teaches that the FET sensor arrays and aptamers as capture probes detect four CVD protein biomarkers (CRP, NT-proBNP, cTnI, and fibrinogen) from untreated clinical samples (Page 157, column 1, paragraph 1, lines 1-3).
SINHA further teaches that using the device and analyzing the current gain from a calibrated chip shows an unknown analyte concentration (Page 161, column 1, last line).
SINHA further teaches of performing a biosensing operation and displaying the corresponding gain of the FETs (post-test measurements) (Page 161, Figure 5, bottom description, & Column 1, last 2 lines).
SINHA even further teaches of SINHA teaches of comparing the test results (post- test measurement) to pre-calibrated chip values (pre-test) (that have the same 4 FET sensors), thereby interpreting concentration values of the biomarkers (Page 161, Figure 5, bottom description, & Column 1, last line).
The FET signal readings are recorded to estimate the amount of protein bound to the aptamers (Page 157, column 2, 2.5, first paragraph lines 8-14).
SINHA teaches that detecting and identifying (reads on “marking,” the assay) having the target material bind to the probe (See Figure 4 and Figure 4 description).
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.
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.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights