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 17/880676 RCE filed 01/19/2026.
Claims 1-20 have been examined and fully considered.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/19/2026 has been entered.
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 & 19-20 are rejected under 35 U.S.C. 103 as being obvious over SINHA in An integrated microfluidic system with field-effect transistor sensor arrays for detecting multiple cardiovascular biomarkers from clinical samples in view of HUANG in US 20180203006.
With respect to Claims 1, 9, 16, 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).
Though SINHA teaches of calibrating as shown above, since 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, SINHA does not teach of coating the probes onto the detection/pixel surface, since SINHA does not teach that the bioFET comprises a pixel. HUANG is also used to remedy this. SINHA also does not teach of, “at least one of the 1st to the Nth assay is not marked as the binding assay.”
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 SINHA 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, SINHA teaches that the microfluidic chip consists of several microfluidic devices and four field-effect transistor (FET)/detection chambers (FET # A, B, C, D for aptamer probes specific to each of the hour protein biomarkers) (See Figure 1, description- c.). Since the FETS detect biological molecules they can be considered bioFETS as claimed. SINHA does not teach that the bioFET comprises a 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 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 to use a pixelated sensor with the 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 Claim 3, SIHNA teaches of the invention as shown above.
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 SINHA 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, SINHA teaches that the microfluidic chip consists of several microfluidic devices and four field-effect transistor (FET)/detection chambers (FET # A, B, C, D for aptamer probes specific to each of the hour protein biomarkers) (See Figure 1, description- c.). Since the FETS detect biological molecules they can be considered bioFETS as claimed. SINHA further teaches that each FET sensor has a source, a drain, and a gate (Figure 1, description, b.). SINHA 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 (Page 157, column 1, last paragraph, column 2, first paragraph). SINHA further teaches of measuring the average of the currents (Figure 4). SINHA 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 SINHA as this is shown to be able to aid in biorecognition (HUANG, paragraph 0057).
With respect to Claim 7, 14, SINHA teaches of selecting of FET detection units (FET# A, B, C, D) (j-k) the controller, and initiating the fluidic transport/applying a sample fluid on the FET integrated microfluidic chip of (Page 161, Figure 5, bottom description, & Column 1, last line & also Figure 2 description).
SINHA further teaches of performing a biosensing operation and displaying the corresponding gain of the FETs (Page 161, Figure 5, bottom description, & Column 1, last line). Though SINHA teaches of calibrating as claimed, they do not make clear that they are performing calibrating specifically for all of the 1st to Nth assays/FET circuit sensors. Further, SINHA does not teach that the bioFET comprises a 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 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 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 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 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.
It would have been obvious to one of ordinary skill in the art to calibrate all assays and sensors of the sensor array as is done in HUANG in the method of SINHA due to the advantage calibrating all sensors/assays has for achieving a clearer detection signal (HUANG, paragraph 0115). The detection in both HUANG and SINHA are taught for multiple sensors at the same time, so this is simultaneous measurement, however it would be obvious to instead perform operations of sensing 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 8, 15, SINHA teaches of selecting of FET detection units (FET# A, B, C, D) (j-k) the controller, and initiating the fluidic transport/applying a sample fluid on the FET integrated microfluidic chip of (Page 161, Figure 5, bottom description, & Column 1, last line & also Figure 2 description).
SINHA further teaches of performing a biosensing operation and displaying the corresponding gain of the FETs (Page 161, Figure 5, bottom description, & Column 1, last line). Though SINHA teaches of calibrating as claimed, they do not make clear that they are performing calibrating specifically for all of the 1st to Nth assays/FET circuit sensors. Further, SINHA does not teach that the bioFET comprises a 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 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 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 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 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.
It would have been obvious to one of ordinary skill in the art to calibrate all assays and sensors of the sensor array as is done in HUANG in the method of SINHA due to the advantage calibrating all sensors/assays has for achieving a clearer detection signal (HUANG, paragraph 0115). The detection in both HUANG and SINHA are taught for multiple sensors at the same time, so this rads on the claimed, “simultaneously,” measurement.
With respect to Claim 13, SINHA teaches that the microfluidic chip (cartridge) consists of several microfluidic devices and four field-effect transistor (FET)/detection chambers (FET # A, B, C, D for aptamer probes specific to each of the hour protein biomarkers) (See Figure 1, description- c.) (this reads on 1st to Nth integrated circuit being all placed into the same cartridge).
With respect to Claim 19, HUANG 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.
However, 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, HUANG 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.
Claims 17-18 are rejected under 35 U.S.C. 103 as being obvious over SINHA in An integrated microfluidic system with field-effect transistor sensor arrays for detecting multiple cardiovascular biomarkers from clinical samples in view of HUANG in US 20180203006 and further in view of RAM in US 20160290957.
With respect to Claim 17, SINHA and HUANG 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).
SINHA and HUANG 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 SINHA and HUANG due to the advantage it has for growing self-aligned regions of SINW (RAM, paragraph 0084).
With respect to Claim 18, SINHA 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.
Response to Arguments
Applicant's arguments filed 01/19/2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the primary reference of SINHA that, “SIHNA seeks to verify the validity of it’s proposed FET sensors,” while the instant invention is drawn to a “method for identifying a target material,” and that all of the four biomarkers looked for in SINHA would be detected and therefore that SINHA doesn’t team of the claimed marking of one of the assays as not binding, which was newly amended 01/19/2025.
With respect to this, the examiner notes that a 103 rejection was made and therefore the HUANG reference teaches of the newly amended claim subject matter of “marking,” an assay as “not,” “binding.”
In response to applicant's arguments against the references individually, one cannot show non-obviousness 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).
HUANG 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.”
With respect to HUANG and RAM however, applicant argues that that they cannot cure any purported deficiencies of SINHA, since they would, “destroy the intended purpose,” of SINHA. Applicant argues that this is the case because SINHA seeks for evaluating the CVD risk in the blood of a patient and four biomarkers that intrinsically exist in human blood and one would not modify SINHA with other biomarkers that do not naturally exist in human blood.
The examiner disagrees with applicant’s argument however also notes that they find this argument confusing, as nothing is claimed about any biomarkers which do not exist in human blood. Further--- SINHA and HUANG and RAM teach of detecting biomarkers/analytes in human blood so they are all analogous prior art and therefore would not destroy the intended purpose of SINHA (See SINHA, abstract, HUANG, paragraph 0033, RAM, paragraph 0150, 0173).Combining methods or parts of methods for detecting compounds in human blood, as was instantly done--- is in fact obvious and the intended purposed of SINHA would not be destroyed.
Further, the examiner notes that the test for obviousness is not whether the features of a secondary reference/s may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
All claims remain rejected.
Conclusion
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758