DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amendments filed 01/21/2026 have been entered. Applicant amendments do not overcome each and every 112(b) rejection set forth in the Office Action mailed 07/28/2025, please see 112(b) section below.
Status of Claims
Claims 1-10, 12-14, and 38 remain pending in the application.
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.
Claim 14 is 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.
Claim 14 recites “wherein the one or more heat management elements include insulating layers or spacers…, or wherein the one or more heat management elements include passive or active conduits to move heat away from the cassette, wherein the one or more heat management elements comprise one or more of…”
However, it is still unclear if the one or more heat elements comprising one or more of radiating surfaces, cooling fins, liquid cooling, Peltier modules, air ducts, or fans are alternatives to the previous two listed.
In the remarks filed 01/21/2026 applicants state that the features recited are alternative features.
Therefore, for examination it will be interpreted that the radiating surfaces and other associated devices are alternatives as well.
It is suggested to amend claim 14 to recite “to move heat away from the cassette, or wherein the one or more heat management elements”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-10, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US-2010/0099094-A1) in view of Federer (US-2009/0120104-A1) and Kobayashi (US-2014/0087455-A1).
Regarding claim 1, Okada teaches a device, comprising:
a cassette (measurement substrate 40) having first and second surfaces, the cassette (40) configured to engage with a microtiter plate (microtiter plate 30) and comprising a plurality of electrodes (measurement electrodes 45) extending from the first surface in the direction of the microtiter plate (30) when the cassette (40) is engaged with the microtiter plate (30) ([0056], Figure 6); and
The limitations “for measuring electrical properties of cell cultures” and “the cassette configured to engage with a microtiter plate” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okada and the apparatus of Okada is capable of measuring electrical properties of cell cultures and engaging with a microtiter plate. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okada (see MPEP §2114).
Please note that the cell cultures nor microtiter plate has not been positively recited in the claim and is thus not part of the device.
[0050]-[0053] describe a first measurement apparatus 20 used in the first embodiment where an amplification reaction of a sample nucleic acid and the measurement of a reduction current are conducted in a container with an electrode, where there is a solution in container 10 that is heated by amplification apparatus 20, where after heating the reduction current of the solution is measured. Figure 6 shows a second measurement apparatus 50 used in the first embodiment that describes where a plurality of sample nucleic acids are simultaneously subjected to amplification reaction and reduction currents that are then measured, where therefore the second measurement apparatus 50 will be heated during the amplification method ([0055], [0056]).
Okada does not teach how the heating operation is conducted.
In the same problem solving area of thermal treatment of samples, Federer teaches a system comprising a thermal block for thermal treatment of samples (Federer; abstract, [0002]).
Specifically, Federer teaches a system 100 comprising an instrument 30 and a thermal block unit 10 that also includes a control processor 40 for processing digital signals 22 received from the thermal block unit 10 via thermal block interface 18, an optical detection 50 and loading unit (not shown in Figure 2), as well as a system processor 60 for control of the system 100 (Federer; [0060], [0061], [0066], [0067], Figure 2). Figure 1 shows the thermal block 10 that comprises temperature regulating units as one or more Peltier elements 11 and one or more heat sinks 12 (Federer; [0056]). There is a sample block 13 in contact with the Peltier elements 11 made of metal for receiving a multiwell plate 15, and there is a heatable cover 16 that is pressed on top of the multiwell plate 15 (Federer; [0056], Figure 1). The thermal block interface is part of an electronic system comprised within the thermal block unit by which electronic communication between the thermal block and instrument is established where the thermal block interface sends digital signals relating to temperature sensors and other measured parameters like electric potential differences, currents, resistances, and the like (Federer; [0030]). The thermal block also comprises a thermal block processor for processing digital signals within the thermal block unit, where processing allows the restoration of the condition of homogeneity and guarantee reproducibility (Federer; [0034], [0035]). The thermal treatment of samples can subject samples to different temperatures varying with times, such as temperature profiles including temperature cycles for example during PCR (Federer; [0023]).
It would have been obvious to one skilled in the art to use the heatable cover and thermal block of Federer with the device comprising cassette and measurement apparatus of Okada because Federer teaches that the system allows for small inhomogeneities to be detected and temperature regulating units can be controlled to restore the condition of homogeneity and guarantee reproducibility (Federer; [0019]).
Okada is silent with regards to specific way the heating operation is conducted, therefore, it would have been necessary and thus obvious to look to the prior art for conventional heating operations. Federer provides this conventional teaching showing that it is known in the art to use a system with a thermal block to thermal cycle samples in a multiwell plate. Therefore, it would have been obvious to one having ordinary skill in the art to make the heating operation be conducted by the system of Federer because Federer teaches that the system is effective for thermal cycling a sample for PCR.
The system of Federer is a housing where the heatable cover 16 will be detachably attached to the measurement substrate 40 of Okada. Further, the system processor 60 of Federer is a data processing module, where the lead wire 13 of Okada that connects terminals of electrodes to the reduction current-measuring apparatus (seen in Figure 5 of Okada, but will also be in Figure 6) is a data acquisition module. The system processor 60 of Federer will be processing the reduction current of the electrodes of Okada
While the system of Federer does teach components such as the heatable cover 16, Peltier elements 11, and heat sink 12 that are understood to be heat management elements, it is unclear if these are capable of minimizing unwanted transfer to the cassette (measurement substrate 40 of Okada) of heat generated by electronics (system processor and lead wire of Federer) comprised in the housing (system of Federer).
In the analogous art of cell culture devices, Kobayashi teaches a cell culture device that includes a control unit (Kobayashi; [0044], [0047]).
Specifically, Kobayashi teaches where the culture device 10 comprises four sections: a cell culture chamber 13, refrigerator 14, control unit 15, and intermediate chamber 16 (Kobayashi; [0048], Figure 1). The control unit 15 is independent of the other sections and is shielded from the temperature, humidity, and carbon dioxide in the cell culture chamber to protect the inside electric devices (Kobayashi; [0049]). Further, the control unit 15 is provided with a fan 52 to aseptically release the inside heat to the outside (Kobayashi; [0049], Figure 1). It is described in [0056] that components such as a computer and power supply provided in the control unit generate heat, where this heat needs to be released.
It would have been obvious to one skilled in the art to modify the system of Federer such that it includes a fan for the system processor because it is taught by Kobayashi that components of a control unit need to have their heat released to the outside of the device (Kobayashi; [0049], [0056]).
The limitations “the housing comprising one or more heat management elements configured to protect the viability of the cell cultures being measured in the microtiter plate, wherein the one or more heat management elements comprise elements configured to minimize unwanted transfer to the cassette of heat generated by electronics comprised in the housing,” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Okada and the apparatus of modified Okada is capable of protecting the viability of cell cultures in the microtiter plate and minimizing unwanted heat transfer to the cassette. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Okada (see MPEP §2114).
Please note that the cell cultures nor microtiter plate have been positively recited, and are thus not a part of the claimed device. Further, by releasing the heat generated by the system processor of Federer to the outside, this will prevent this heat from interfering with samples, as well as minimizing heat transfer to the cassette (measurement substrate of Okada).
Regarding claim 2, modified Okada teaches the device according to claim 1. Okada further teaches wherein the device is configured for potentiometry, voltammetry.
Please see Okada [0048] which describes electrochemical measurement can be conducted using a potentiostat, where the method includes CV, LSV, DPV, CC, CA, and impedance measurement. These electrochemical measurements are being processed by the system processor 60 of Federer. Therefore, the electrodes of Okada and the system processor of Federer will be capable of potentiometry and voltammetry.
The limitations of claim 2 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Okada and the apparatus of modified Okada is capable of potentiometry, voltammetry. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Okada (see MPEP §2114).
Regarding claim 3, modified Okada teaches the device according to claim 1.
The limitations of claim 3 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Okada and the apparatus of modified Okada is capable of measuring transepithelial or transendothelial electrical resistance (TEER). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Okada (see MPEP §2114).
The electrochemical measurement described in [0048] of Okada would be capable of measuring transepithelial or transendothelial electrical resistance, where the measurements are being processed by the system processor 60 of Federer.
Regarding claim 5, modified Okada teaches the device according to claim 1. Okada further teaches wherein the plurality of electrodes (45) are disposed in a predetermined configuration corresponding to the configuration of at least two or more wells of the microtiter plate (30) (Okada; Figure 6).
Please note that the microtiter plate has not been positively recited in the claim, and is therefore not a part of the device. Thus, the limitation “wherein the microtiter plate comprises 96 microfluidic chips and wherein the microtiter plate is a 384 well plate complying to the ANSI SLAS standards 1 to 4-2004.” is not required.
Regarding claim 6, modified Okada teaches the device according to claim 5.
The limitations of claim 6 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okada and the electrodes of Okada are capable of corresponding to at least one subset of wells of the at least two or more wells that are microfluidically connected in the microtiter plate. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okada (see MPEP §2114).
Further, the microtiter plate has not been positively recited in the claim, and is therefore not part of the device.
Regarding claim 7, modified Okada teaches the device according to claim 5.
Please see Figure 6 of Okada that shows the electrodes immersed in a fluid held by the wells 35.
The limitations of claim 7 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okada and the electrodes of Okada are capable of being immersed in fluid inside the wells to incorporate the fluid in an electrical circuit. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okada (see MPEP §2114).
The microtiter plate, wells, and fluid inside the wells have not been positively recited in the claim and therefore is not part of the device.
Regarding claim 8, modified Okada teaches the device according to claim 6. Okada further teaches wherein each subset of the electrodes contains at least a load, sense and reference electrode (Okada; [0056], [0068]-[0069] see working electrode, counter electrode, and reference electrode which are a load, sense, and reference electrode respectively).
Please see [00056] of the instant specification that recites “In some examples, each subset of electrodes contains at least a load or working electrode…”
Regarding claim 9, modified Okada teaches the device according to claim 6. Okada further teaches wherein each subset of the electrodes contains two or more of the electrodes that are directly connected in an electrical circuit (Okada; Figure 6).
The limitations “wherein said two or more electrodes are connected to one or more of the wells of a microfluidic channel to reduce the effective electrical resistance of the channel, wherein two or more of said subset of electrodes are configured such that the electrical circuit, formed when the cassette is engaged with the microtiter plate, has similar electrical resistance across the electrodes that are directly connected in the electrical circuit, minimizing the effect of the position of local differences in electrical characteristics on the apparent electrical characteristics of the electrical circuit.” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okada and the electrodes of Okada are capable of being connected to one or more of the wells of a microfluidic channel to reduce the effect of electrical resistance of the channel, forming an electrical circuit when the cassette is engaged with a microtiter plate, minimizing the effect of the position of local differences in electrical characteristics on the apparent electrical characteristics of the electrical circuit. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okada (see MPEP §2114).
The wells of a microfluidic channel and microtiter plate are not positively recited in the claims, and are therefore not part of the device.
Regarding claim 10, modified Okada teaches the device according to claim 1. Okada teaches wherein two or more electrodes of the plurality of electrodes are immersed into a single well (Okada; Figure 6).
The limitation “thereby allowing for a 4- point electrical measurement which enables better electrical characterization of an electrical circuit and/or device under test (DUT).” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okada and the electrodes of Okada are capable of allowing for a 4-point electrical measurement to enable better electrical characterization of an electrical circuit and/or device under test. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okada (see MPEP §2114).
Regarding claim 12, modified Okada teaches the device according to claim 1. Okada further teaches wherein the electrodes comprise a biocompatible material, wherein the biocompatible material is one or more of platinum (Okada; [0031] see sample nucleic acids are extracted from various samples such as blood, serum, leukocyte, urine, [0052] see material of the electrode is platinum).
Regarding claim 13, modified Okada teaches the device according to claim 1. Okada further teaches wherein the electrodes (45) comprise one or more of a biofunctionalized electrode (Okada; [0052] see electrode subjected to molecular modification to improve sensitivity where the listed modifications are understood to biofunctionalized the electrode).
Regarding claim 14, modified Okada teaches the device according to claim 1. Kobayashi further teaches wherein the one or more heat management elements comprise one or more of fans improving airflow through or around the device (Kobayashi; [0049]).
Please note that the heat management elements include insulating layer or spacers between the housing and cassette, passive or active heat conduits, radiating surfaces, cooling fins, liquid cooling, Peltier modules, air ducts, are not required as they are alternatives of the heat management elements.
Additionally, please note that the fan 52 seen in Figure 3 of Kobayashi directs air out an exhaust filter, and therefore may also be considered an active heat conduit or an air duct.
Claim(s) 4, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US-2010/0099094-A1), Federer (US-2009/0120104-A1), and Kobayashi (US-2014/0087455-A1), and in further view of Gourishankar (US-2011/0108439-A1).
Regarding claim 4, modified Okada teaches the device according to claim 1. The system of Federer does have an optical detection unit that detects the result of the effect of thermal treatment. Further the system processor 60 of Federer will be processing the measurements of the electrodes of Okada. However, Federer does not teach AC frequency sweeps.
In the analogous art of determining electrochemical impedance, Gourishankar teaches a sensor comprising a potentiostat and frequency response analyzer (Gourishankar; abstract, [0036]).
Specifically, Gourishankar teaches where the sensor 100 includes an electrochemical impedance analyzer shown at 136 that comprises the potentiostat and the frequency response analyzer (Gourishankar; [0036], Figure 3). The analyzer 136 is electrically connected to electrodes 116 and 124 to provide an input perturbation signal and to measure an output impedance signal of sensor 100, where the input perturbation signal is a sinusoidal current or voltage waveform sweeping in a frequency range between 0.001 Hz and 10 MHz (Gourishankar; [0036]).
Okada and Federer are silent with regards to specific frequency sweep, therefore, it would have been necessary and thus obvious to look to the prior art for conventional frequency sweeps. Gourishankar provides this conventional teaching showing that it is known in the art to use a sweeping frequency in the range of 0.001 Hz and 10 MHz. Therefore, it would have been obvious to one having ordinary skill in the art to make the processor of Federer use sweeping frequencies in the range of 0.001 Hz and 10 MHz because it is taught by Gourishankar that this range is effective for measuring electrochemical impedance.
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the sweeping frequency in the range that corresponds to the claimed range. See MPEP 2144.05(I).
The lead wire that connects the electrodes of Okada to the system processor 60 of Federer is the data acquisition module where the lead wire and the frequency sweep of the system processor will be adaptable in a manual, automated or iterative fashion. It is understood that the frequency of Gourishankar is optimized to characteristics being measured.
Regarding claim 38, modified Okada teaches the device according to claim 4. Gourishankar further teaches wherein the processor is configured to perform AC frequency sweeps in a range of from 10 Hz to 10 Mhz, please see claim 4 supra.
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 6, filed 01/21/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Okada (US-2010/0099094-A1), Federer (US-2009/0120104-A1), and Kobayashi (US-2014/0087455-A1).
In response to applicant's argument that Okada nor Federer teach that protecting cells from unwanted heat transfer is a problem in need of a solution or that stable temperature should be maintained over a prolonged period, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Further, please note that Kobayashi is now being used to teach a heat management element.
Additionally, in response to applicant's argument regarding protecting cells from unwanted heat transfer is not taught or is addressed as a problem in need of a solution, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., maintaining a stable temperature for prolonged period of time over the course of days, weeks, or months [for] performing measurements [of samples] at intervals of hours, days, weeks, or months) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further, as noted above, the cell cultures nor microtiter plate are positively recited in the claim, and is therefore not a part of the claimed device.
Applicant argues on page 8 that Okada in view of Federer would be incapable of minimizing unwanted transfer of heat generated by electronics comprised in a housing, at least because the heatable cover 16 can only provide additional heat to the top side of the measurement block 40 and cannot minimize heat from being transferred through it. Applicant also argues on page 9 that attempting to control the temperature using Peltier elements would not minimize heat generated by the electronics of measuring block 40 or heatable cover from being transferred into a sample.
Please note that the electronics within the housing are being mapped to the system processor of Federer and lead wire of Okada, not electronics within the measuring block or heatable cover. Additionally, Kobayashi is now being used to teach the heat management element.
Applicant arguments on page 9 that Federer teaches away from the claimed invention because Federer is specific for transferring heat to and from a sample rather than what the claimed invention is doing (minimizing transfer of heat from electronics in a housing to a sample to maintain its thermal stability).
Examiner does agree that Federer teaches that the heatable cover which will be applied to the measurement substrate of Okada. However, currently the claim requires that the heat management elements are configured to minimize unwanted transfer to the cassette of heat generated by electronics comprised in the housing. In this case, the heatable cover would be applying “wanted” heat transfer, and with the modification of Kobayashi to include fans for the processor this will be minimizing unwanted transfer to the measurement substrate from heat generated by the processor and lead wire. In other words, the claim is not limiting the cassette to have no heat transferred to it whatsoever, just that unwanted heat transfer is minimized.
Additionally, the claim language “minimized” does imply that some heat can be transferred to the cassette.
Conclusion
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.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759