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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 May 2026 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 29 May 2026. Claims 1-4, 6-9, 11-15, and 21-27 are currently pending in the application. Claims 5, 10, and 16-20 are canceled. Claim 27 is newly added. Claims 1-4, 6-9, 11-15, and 21-27 are being examined herein.
Status of Objections and Rejections
The rejection of claim 10 under 35 U.S.C. § 112(d) is withdrawn in view of cancelation of the claim.
The rejections of claims 8-11, 13-15, 21, and 23-26 under 35 U.S.C. § 102(a)(1) in view of Arlett, et. al. (US 20180021783 A1) are withdrawn in view of amendments.
The rejections of claims 1-4, 6-7, and 22 under 35 U.S.C. § 103) in view of Arlett, et. al. (US 20180021783 A1) in view of Cumming, et. al. (US 20200292459 A1) are withdrawn in view of amendments.
The rejection of claim 12 under 35 U.S.C. § 103) in view of Arlett, et. al. (US 20180021783 A1) in view of Cumming, et. al. (US 20200292459 A1) in further view of Galen, et. al. (US 20210341360 A1) are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see remarks pg. 9-11, filed 29 May 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 103) in view of Arlett, et. al. (US 20180021783 A1) in view of Cumming, et. al. (US 20200292459 A1) and claims 8 and 21 under 35 U.S.C. § 102(a)(1) in view of Arlett, et. al. (US 20180021783 A1) 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 Therefore, the rejection has been withdrawn.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 Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022).
Applicant offers no arguments outside of Arlett either alone or in combination with the other art recited in the rejection of record no longer reads on newly amended independent claims 1, 8, and 21.
Examiner notes no specific argument was made against the use of Galen, et. al. (US 20210341360 A1) and continues to be used in the rejection provided below.
Specification
The disclosure is objected to because of the following informalities:
“second opening” is assigned different labels in different paragraph. Examiner is associating the “second opening” with label 1263.
Par. 0054, lines, 14 and 5: given labels 1261 and 1262 (respectively)
Par. 0055, line, 18: given label 1261
“sample inlet” is assigned different labels in different paragraph. Examiner is associating the “sample inlet” with label 1252.
Par. 0053, line, 17: given label 1251
Appropriate correction is required.
Claim Objections
Claims 2 and 23 are objected to because of the following informalities:
Claim 2 is missing the word “the” or “said” in front of “fluidic channel” in line 3 of the claim.
Claim 23 is missing the word “the” or “said” in front of “fluidic channel” in line 4 of the claim.
Appropriate correction is required.
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 3, 8-9, 11-15, and 27 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.
Claim 3 recites the limitation, “and a biosensor chip…” in line 2 of the claim. A biosensor chip is previously recited in claim 1 from which claim 3 depends. It is unclear if this is the same or a different biosensor chip as recited in claim 1. Examiner believes it to be the same biosensor chip in claim 1 and recommends amending the claim to recite, “and the biosensor chip…” or an equivalent thereof.
Claim 8 recites the limitation "from the sample fluid in…" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim as no sample fluid is previously recited in the claim. Examiner recommends amending the claim to recite, “from a sample fluid in…" or an equivalent thereof.
Claims 9, 11-15, and 27 are rejected based on their dependence on claim 8.
Claim 9 recited the limitation “for driving a sample fluid…” in lines 5-6 of the claim. Claim 8 from which claim 9 depends previously recites a sample fluid and it is unclear if this is the same sample fluid from claim 8 or a new sample fluid. Examiner recommends amending the claim to recite, “for driving the sample fluid…” or an equivalent thereof.
Claim 27 is rejected based on its dependence on claim 9.
Claim 11 recites the limitation "the discharged chamber for filtering fluids form the discharged chamber" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 8 recites “a plurality of discharged chambers” and it is unclear if “the discharged chamber” is a different discharged chamber than the plurality of discharged chambers or if it is one of the plurality of discharged chambers. Examiner believes this to be at least one of the plurality of discharged chambers and will be examined as such. Examiner recommends amending the claim to recite “a discharged chamber of the plurality of discharged chambers for filtering fluids from the discharged chamber” or an equivalent thereof.
Claim 27 recites the limitation, “a second pump are in…” in line 2 of the claim. A second pump is previously recited in claim 9 from which claim 27 depends on and it is unclear if a second pump of claim 27 is the same or a different second pump as recited in claim 9. The examiner believes the second pump of claim 27 is the same second pump as claim 9 and will be examined as such. Examiner recommends amending the claim to recited “the second pump are in…” or an equivalent thereof.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-8, 13-14, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022).
Regarding claim 1, Lin teaches a sensing system with a readout device paired with a sensor cartridge with micro-channels and sensing chip (Abstract). Lin teaches a sensor cartridge 10 comprises a housing 15 (casing) with a top layer 15-1 and a bottom layer 15-3 wherein the top layer 15-1 comprises a sample inlet 16 (also corresponds to label 11-2) (sample inlet) and at least one buffer reservoir 11-1 (buffer inlet) (Fig. 3, 5) (a casing comprising a sample inlet and a buffer inlet). Lin teaches within housing 15 is substrate 19 that holds electronic components like a microchip with biosensor components (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045) wherein the biosensor components are a sensor chip 32 (Fig. 6, par. 0051), and sensor chip 32 can hold an array of multiple micro-sensor elements (Fig. 8; par. 0059) (a biosensor package disposed in the casing and comprising a sensor array and a reference electrode).
Lin teaches the device further comprises a lower channel layer 18 (a first channel frame) above substrate 19 (a first channel frame disposed over the biosensor package) and a middle layer 15-2 (a second channel frame) above lower channel layer 18 (a second channel frame disposed over the first channel frame) (Fig. 5; par. 0040). Lin teaches middle layer 15-2 and channel layer 18 come together to from a fluidic channel wherein the upper fluidic channel fluidically connects sample inlet 11-2 and reservoir inlet 11-1 to the fluidic channel (Fig. 6) (wherein the first channel frame and the second channel frame jointly form a fluidic channel connected to the sample inlet and the buffer inlet). Lin teaches channel layer 18 has at least one opening (see middle arrow in provided Fig. 6 below) through the depth of channel layer 18 and above sensor chip 32 for the fluidic channel to access a micro-sensor elements of sensor chip 32 (wherein the first channel frame comprises a first opening at least partially overlaps the sensor array in a thickness direction of the fluidic cartridge module). Channel layer 18 further comprises an additional hole (see leftmost arrow in provided Fig. 6 below) through the depth of the channel layer 18 and above reference electrode 31 for the fluidic channel to access the reference electrode 31 (a second opening at least partially overlaps the reference electrode in the thickness direction). Lin teaches channel layer 18 has a shape to accommodate the sensor chip 32 creating a concaved portion (see outlined portion in provided Fig. 6 below that outlines a first side of the concave) (and a concave disposed on a lower surface of the first channel frame for accommodating a biosensor chip of the biosensor package).
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Regarding claim 2, Lin teaches at the terminal end of the fluidic channel is a chamber (see rightmost arrow in provided Fig. 6 above) for collecting fluid downstream the fluidic channel (Fig. 6; par. 0054) (wherein the fluidic cartridge module further comprises a discharged chamber collecting fluids flowing through fluidic channel).
Regarding claim 3, Lin teaches substrate 19 holds chip member 32 (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045, 0058) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Lin teaches substrate 19 further comprises contact pads 33C at one end of the substrate to electrically connect the sensor cartridge 10 to a readout device (Fig. 2A, 7; par. 0034, 0088) (the substrate comprises an edge connector electrically connected to the biosensor chip and a processor). The readout device 20 comprises a module 23 for electronic readout, powering, output, and detection results (par. 0031) and therefore is considered "a processor".
Regarding claim 6, Lin teaches middle layer 15-2 (see outlined portioned in provided Fig. 6 below) has a missing portion (channel groove) on the upper side to form the channel connecting inlets 11-2, 11-1 to the fluidic channel (wherein the second channel frame comprises a channel groove connected to the sample inlet and the buffer inlet). An additional portion of middle layer 15-2 defines the opening to the reference electrode 31 (see leftmost arrow in provided Fig. 6 below) (and passing through the first opening) and another portion defines the uppermost boundary (see rightmost arrow) of the opening leading to the sensor chip 32 (and the second opening).
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Regarding claim 7, Lin teaches substrate 19 holds chip member 32 (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045, 0058) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate).
Regarding claim 8, Lin teaches a sensing system with a readout device paired with a sensor cartridge with micro-channels and sensing chip (Abstract). Lin teaches a sensor cartridge 10 (a fluidic cartridge module) that is configured to be inserted in and operated by readout device 20 (a housing) (Fig. 2A) (a fluidic cartridge module disposed on the housing).
Lin teaches the cartridge comprises a housing 15 comprising a microfluidic channel with a sample inlet 16 (also corresponds to label 11-2) (sample inlet) and at least one buffer reservoir 11-1 (buffer inlet) (Fig. 3, 5). Lin teaches within housing 15 is substrate 19 that holds electronic components like a microchip with biosensor components (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045) wherein the biosensor components are a sensor chip 32 (Fig. 6, par. 0051), and sensor chip 31 can hold an array of multiple micro-sensor elements (sensor array) (Fig. 8; par. 0059) (a biosensor package comprising a sensor array).
Lin teaches at the terminal end of the fluidic channel is a chamber (discharge chamber) (see rightmost arrow in provided Fig. 6 below) for collecting fluid downstream the fluidic channel (Fig. 6; par. 0054) and an additional chamber (discharge chamber) (see chamber to the right of 11-1 in provided Fig. 6 below) that is at the start of the fluidic channel and is capable of holding fluid (par. 0041) (a plurality of discharged chambers) (comprising a sample inlet, a buffer inlet, a biosensor package comprising a sensor array, a plurality of discharged chambers, and a reference electrode). Examiner notes while both chambers are on the same side of the cartridge, the chambers are still on opposite ends of the fluidic channel that starts at the uppermost chamber and terminates at the lowermost chamber (and the plurality of discharged chambers…are respectively disposed at terminal ends of the fluidic channel and in fluid communication with the fluidic channel). Waste chamber, also labeled 18-1C (Fig. 7), comprises an air vent 18-2C to regulate pressure within the fluidic channel (Fig. 7, par. 0067) (configured to expel fluid from the fluidic cartridge). As seen in Figure 3 onboard reservoirs, see the rightmost reservoir of 11-1, are technically opened on the top of housing 15 for loading fluids and store the fluids outside of housing 15 of cartridge 10 (par. 0038) and pumping components of the readout device 20 induce fluid movement (par. 0032). Therefore, the uppermost chamber (discharge chamber) is fully capable of storing fluid outside of the housing 15 of cartridge 10 and expelling fluid from the fluidic channel through provided pumping components (and the plurality of discharged chambers are configured to expel fluid from the fluidic channel to outside of the fluidic cartridge module).
Lin teaches wherein the fluidic channel is disposed over sensor chip 32 (see the space above sensor chip 32 in Fig. 6) and is fluidically connected to sample inlet 11-2 and chamber 11-1 (and a fluidic channel disposed over the biosensor package and connected to the sample inlet and the buffer inlet).
Lin teaches channel layer 18 has at least one opening (see middle arrow in provided Fig. 6 below) through the depth of channel layer 18 and above sensor chip 32 for the fluidic channel to access a micro-sensor elements of sensor chip 32 (wherein the fluidic channel comprises a first opening aligned with the sensor array). Channel layer 18 further comprises an additional hole (see leftmost arrow in provided Fig. 6 below) through the depth of the channel layer 18 and above reference electrode 31 for the fluidic channel to access the reference electrode 31 (and a second opening aligned with the reference electrode).
Lin teaches the readout device 20 (housing) comprises a readout module 23 for electronic readout, a powering module 24, and an output module 25 for outputting detection results (par. 0031) and therefore is considered "a processor" (Fig. 2A, 2B) and is electrically coupled to cartridge 10 through interfacing/corresponding I/O ports (par. 0031) (a processor disposed in the housing electrically coupled to the fluidic cartridge module). Lin teaches wherein readout module 23 comprises "application specific circuit components designed to detect and convert variations in target analyte concentration into an electrical signal" (par. 0033) (wherein the processor is configured to determine a concentration level of a given analyte from the sample fluid in the fluidic cartridge module based on signals received from the sensor array).
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Regarding claim 14, Lin teaches substrate 19 holds chip member 32 (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045, 0058) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Lin teaches substrate 19 further comprises contact pads 33C at one end of the substrate to electrically connect the sensor cartridge 10 to a readout device (Fig. 2A, 2B, 7; par. 0034, 0088) (the substrate comprises an edge connector electrically connected to the biosensor chip and the processor).
Regarding claim 21, Lin teaches a sensing system with a readout device paired with a sensor cartridge with micro-channels and sensing chip (Abstract). Lin teaches a sensor cartridge 10 comprises a housing 15 (casing) with a top layer 15-1 and a bottom layer 15-3 wherein the top layer 15-1 comprises a sample inlet 16 (also corresponds to label 11-2) (sample inlet) and at least one buffer reservoir 11-1 (buffer inlet) (Fig. 3, 5) (a casing comprising a sample inlet and a buffer inlet). Lin teaches within housing 15 is substrate 19 that holds electronic components like a microchip with biosensor components (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045) wherein the biosensor components are a sensor chip 32 (Fig. 6, par. 0051), and sensor chip 31 can hold an array of multiple micro-sensor elements (Fig. 8; par. 0059) (a biosensor package disposed in the casing and comprising a sensor array and a reference electrode).
Lin teaches the device further comprises a lower channel layer 18 (a first channel frame) above substrate 19 (a first channel frame disposed over the biosensor package) and a middle layer 15-2 (a second channel frame) above lower channel layer 18 (a second channel frame disposed over the first channel frame) (Fig. 5; par. 0040). Lin teaches middle layer 15-2 and channel layer 18 come together to from a fluidic channel wherein the upper fluidic channel fluidically connects sample inlet 11-2 and reservoir inlet 11-1 to the fluidic channel (Fig. 6) (wherein the first channel frame and the second channel frame jointly form a fluidic channel connected to the sample inlet and the buffer inlet). Lin teaches channel layer 18 has at least one opening (see middle arrow in provided Fig. 6 below) through the depth of channel layer 18 and above sensor chip 32 for the fluidic channel to access sensor chip 32 (wherein the first channel frame comprises a first opening at least partially overlaps the sensor array in a thickness direction of the fluidic cartridge module). Channel layer 18 further comprises an additional hole (see leftmost arrow in provided Fig. 6 below) through the depth of the channel layer 18 and above reference electrode 31 for the fluidic channel to access the reference electrode 31 (a second opening at least partially overlaps the reference electrode in the thickness direction).
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Lin teaches middle layer 15-2 (see outlined portioned in provided Fig. 6 below) has a missing portion (channel groove) on the upper side to form the channel connecting inlets 11-2, 11-1 to the fluidic channel (and the second channel frame comprises a channel groove connected to the sample inlet and the buffer inlet). An additional portion of middle layer 15-2 defines the opening to the reference electrode 31 (see leftmost arrow in provided Fig. 6 below) (and passing through the first opening) and another portion defines the uppermost boundary (see rightmost arrow) of the opening leading to the sensor chip 32 (and the second opening).
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Regarding claim 22, Lin teaches substrate 19 holds chip member 32 (Fig. 5; par. 0044) and an electrode member 31 like a reference electrode (Fig. 5; par. 0045, 0058) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Lin teaches channel layer 18 has a shape to accommodate the sensor chip 32 creating a concaved portion (see outlined portion in provided Fig. 6 below that outlines a first side of the concave) (and a concave disposed on a lower surface of the first channel frame for accommodating a biosensor chip of the biosensor package).
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Regarding claim 23, Lin teaches at the terminal end of the fluidic channel is a chamber (discharge chamber) (see rightmost arrow in provided Fig. 6 above) for collecting fluid downstream the fluidic channel (Fig. 6; par. 0054) and an additional chamber (discharge chamber) (see chamber to the right of 11-1 in provided Fig. 6 above) that is at the start of the fluidic channel and is capable of holding fluid (par. 0041) (further comprising a plurality of discharged chambers disposed at opposite ends of the fluidic channel and in fluid communication with the fluidic channel for collecting fluids flowing through fluidic channel). Examiner notes while both chambers are on the same side of the cartridge, the chambers are still on opposite ends of the fluidic channel that starts at the uppermost chamber and terminates at the lowermost chamber.
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 nonobviousness.
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 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022) as applied to claims 1 and 8 respectively, in view of Hsiao, et. al. (US 20220033759 A1; with a filing date of 30 July 2020).
Regarding claim 4, Lin teaches the limitations as applied to claim 1 (see above).
Lin is silent to wherein the biosensor package comprises a plurality of biosensor chips, and the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively.
Hsiao teaches an apparatus for cell monitoring using a sensing chip and channel module (Abstract). Hsiao teaches the apparatus comprises (Fig. 1, 6): a base module 600 and cover module region 510 (a casing) surrounding a sensing chip 100 (a biosensor package). Sensing chip 100 is covered by a channel module 200 (a first channel frame) and cover module region 520 (a second channel frame) atop the channel module 200 (Fig. 1).
Hsiao teaches a microchannel 210 is formed through channel module 200 and cover module region 520, wherein two connecting channels 211, 212, fluidically connecting microchannel 210 to through holes 541, 542 (Fig. 6; par. 0029).
Hsiao teaches the sensing chip 100 comprises sensing region 112 (a biosensor chip) that can accommodate a plurality of microwells 3216A-C, 3226A-C (sensing arrays) (Fig. 12C). As seen in Figure 12C, the fluidic channel splits 3214, 3224 to access physically separated cultivation regions 3215, 3225 with physically separated sensing regions (plurality of biosensor chips) corresponding to physically separated microwells 3216A-C, 3226A-C (sensor arrays) (wherein the biosensor package comprises a plurality of biosensor chips, and the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively). Hsiao teaches this embodiment has the benefit of running simultaneous tests and control experiments (par. 0046).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the fluidic cartridge with only a single sensor chip and first opening of Lin to have multiple biosensor chips each with a respective first opening as taught by Hsiao because multiple chips allows for the running of simultaneous tests and control experiments (Hsiao, par. 0046) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 15, Lin teaches the limitations as applied to claim 1 (see above).
Lin is silent to wherein the biosensor package comprises a plurality of biosensor chips, and the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively.
Hsiao teaches an apparatus for cell monitoring using a sensing chip and channel module (Abstract). Hsiao teaches the apparatus comprises (Fig. 1, 6): a base module 600 and cover module region 510 (a casing) surrounding a sensing chip 100 (a biosensor package). Sensing chip 100 is covered by a channel module 200 (a first channel frame) and cover module region 520 (a second channel frame) atop the channel module 200 (Fig. 1).
Hsiao teaches a microchannel 210 is formed through channel module 200 and cover module region 520, wherein two connecting channels 211, 212, fluidically connecting microchannel 210 to through holes 541, 542 (Fig. 6; par. 0029).
Hsiao teaches the sensing chip 100 comprises sensing region 112 (a biosensor chip) that can accommodate a plurality of microwells 3216A-C, 3226A-C (sensing arrays) (Fig. 12C). As seen in Figure 12C, the fluidic channel splits 3214, 3224 to access physically separated cultivation regions 3215, 3225 with physically separated sensing regions (plurality of biosensor chips) corresponding to physically separated microwells 3216A-C, 3226A-C (sensor arrays) (wherein the biosensor package comprises a plurality of biosensor chips, and the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively). Hsiao teaches this embodiment has the benefit of running simultaneous tests and control experiments (par. 0046).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the fluidic cartridge with only a single sensor chip and first opening of Lin to have multiple biosensor chips each with a respective first opening as taught by Hsiao because multiple chips allows for the running of simultaneous tests and control experiments (Hsiao, par. 0046) with reasonable expectation of success. MPEP 2143(I)(G).
Claims 9 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022) as applied to claim 8, in view of Huang, et. al. (US 20180203006 A1).
Regarding claim 9, Lin teaches readout device 20 comprises fluid driving module 21 comprises pumping components to induce flow within the cartridge (par. 0032). Lin teaches such pumping components include a pump to engage fluid in the micro-channel structure to "to induce flow of the fluids in the flow paths defined in the micro-channel structure" (par. 0035) (pump in fluid communication with the fluidic channel for driving a buffer fluid from the buffer inlet to flow passing the first opening and the second opening) (pump in fluid communication with the fluidic channel for driving a sample fluid from the sample inlet to flow passing the first opening and the second opening).
Lin is silent to a second pump.
Huang teaches a fluidic cartridge with a sensor array (Abstract). Huang teaches a biosensing cartridge 102 comprising an array of sensors 104 (Fig. 1; 0051-0052). Huang teaches the fluidic cartridge has a fluidic component/design having microfluidic channels and fluidic inlets for moving fluids from outside the platform to inside the biosensing chip platform (Fig. 1; par. 0051, 0054). Specifically, Huang teaches fluidic cartridge 1000 includes a housing 1002 with at least three channels 1004, 1006, 1008, and fluid inlets 1010a, 1010b and sample inlet 1014 (Fig. 10; par. 0095, 0100). Huang teaches third channel 1008, fluidically connected to both inlets as seen in Figure 10, has opening 814 over the sensor array (par. 0096). Huang teaches reference electrode 906 is also in third channel 1008 and the reference electrode is aligned with opening 814 (Fig. 10; par. 0094, 0096). Huang teaches this fluid input and motion through inlets and through the fluidic channel are driven by pressure induced by a first syringe pump 1201a and a second syringe pump 1202b that are actuated by corresponding actuators 1206a, 1206b(Fig. 12; par. 0105-0106). Huang teaches each syringe pump 1202a/b are configured to hold different fluids (a first pump in fluid communication with the fluidic channel for driving a buffer fluid from the buffer inlet) (a second pump in fluid communication with the fluidic channel for driving a sample fluid from the sample inlet) with independent actuation which allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (par. 0105-0106).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the fluid driving module comprising a singular pump of Lin to further include a second pump as taught by Huang because a first and second (syringe) pump with independent actuation allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (Huang, par. 0105-0106) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 27, modified Lin teaches fluid driving module 21 comprises pumping components to induce flow within the cartridge (Lin, par. 0032). Lin teaches such pumping components include a pump to engage fluid in the micro-channel structure to "to induce flow of the fluids in the flow paths defined in the micro-channel structure" (Lin, par. 0035) this includes the plurality of discharged chambers. Modified Lin in view of Huang teaches the fluid communication are driven by a first syringe pump 1201a and a second syringe pump 1202b that are actuated by corresponding actuators 1206a, 1206b(Huang, Fig. 12; par. 0105-0106) (wherein the first pump and a second pump are in fluid communication with the plurality of discharged chambers respectively).
Claims 11 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022) as applied to claim 8 and 23 respectively, in view of Miller, et. al. (US 20120142026 A1).
Regarding claim 11, Lin teaches at the terminal end of the fluidic channel is a waste chamber 18-1C (discharge chamber) for collecting fluid downstream the fluidic channel with an air vent 18-2C within lower channel layer 18C of cartridge 10 (in the housing) that is capable of holding fluid (Fig. 7; par. 0067).
Lin is silent to the device further comprising a filter disposed in the housing and in fluid communication with the discharged chamber for filtering the fluids from the discharged chamber.
Miller teaches a cartridge for rapid liquid sample analysis (Abstract). Miller teaches a cartridge comprising a sample inlet, holding chamber, analysis circuit, pump membrane/pump means, assay components, and a waste chamber (discharged chamber) (Fig. 1-3; par. 0040-0044, 0047). Miller teaches the waste chamber can further comprise a valve with a filter to allow for air movement between the cartridge and outside environment and to keep fluid inside the cartridge (par. 0053) (further comprising a filter disposed in the housing and in fluid communication with the discharged chamber for filtering the fluids from the discharged chamber). Miller teaches the waste chamber is configured to collect fluid from the cartridge to contamination outside the cartridge while also allowing the benefit of venting (par. 0052).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the air vent within the waster chamber as taught by Lin to further include a filter as taught by Miller because a filter allows for venting of the cartridge while preventing contamination (Miller, par. 0052) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 26, Lin teaches at the terminal end of the fluidic channel is a waste chamber 18-1C (discharge chamber) for collecting fluid downstream the fluidic channel with an air vent 18-2C within lower channel layer 18C of cartridge 10 (in the housing) that is capable of holding fluid (Fig. 7; par. 0067).
Lin is silent to the device further comprising a filter disposed in the housing and in fluid communication with the discharged chamber for filtering the fluids from the discharged chamber.
Miller teaches a cartridge for rapid liquid sample analysis (Abstract). Miller teaches a cartridge comprising a sample inlet, holding chamber, analysis circuit, pump membrane/pump means, assay components, and a waste chamber (discharged chamber) (Fig. 1-3; par. 0040-0044, 0047). Miller teaches the waste chamber can further comprise a valve with a filter to allow for air movement between the cartridge and outside environment and to keep fluid inside the cartridge (par. 0053) (further comprising a filter disposed in the casing and in fluid communication with the plurality of discharged chambers for filtering the fluids from the plurality of discharged chambers). Miller teaches the waste chamber is configured to collect fluid from the cartridge to contamination outside the cartridge while also allowing the benefit of venting (par. 0052).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the air vent within the waster chamber as taught by Lin to further include a filter as taught by Miller because a filter allows for venting of the cartridge while preventing contamination (Miller, par. 0052) with reasonable expectation of success. MPEP 2143(I)(G).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022) as applied to claim 21, in view of Huang, et. al. (US 20180203006 A1).
Regarding claim 24, Lin teaches readout device 20 comprises fluid driving module 21 comprises pumping components to induce flow within the cartridge (par. 0032). Lin teaches such pumping components include a pump to engage fluid in the micro-channel structure to "to induce flow of the fluids in the flow paths defined in the micro-channel structure" (par. 0035) (pump in fluid communication with the fluidic channel for driving a buffer fluid from the buffer inlet to flow passing the first opening and the second opening) (pump in fluid communication with the fluidic channel for driving a sample fluid from the sample inlet to flow passing the first opening and the second opening).
Lin is silent to a second pump.
Huang teaches a fluidic cartridge with a sensor array (Abstract). Huang teaches a biosensing cartridge 102 comprising an array of sensors 104 (Fig. 1; 0051-0052). Huang teaches the fluidic cartridge has a fluidic component/design having microfluidic channels and fluidic inlets for moving fluids from outside the platform to inside the biosensing chip platform (Fig. 1; par. 0051, 0054). Specifically, Huang teaches fluidic cartridge 1000 includes a housing 1002 with at least three channels 1004, 1006, 1008, and fluid inlets 1010a, 1010b and sample inlet 1014 (Fig. 10; par. 0095, 0100). Huang teaches third channel 1008, fluidically connected to both inlets as seen in Figure 10, has opening 814 over the sensor array (par. 0096). Huang teaches reference electrode 906 is also in third channel 1008 and the reference electrode is aligned with opening 814 (Fig. 10; par. 0094, 0096). Huang teaches this fluid input and motion through inlets and through the fluidic channel are driven by pressure induced by a first syringe pump 1201a and a second syringe pump 1202b that are actuated by corresponding actuators 1206a, 1206b(Fig. 12; par. 0105-0106). Huang teaches each syringe pump 1202a/b are configured to hold different fluids (a first pump in fluid communication with the fluidic channel for driving a buffer fluid from the buffer inlet) (a second pump in fluid communication with the fluidic channel for driving a sample fluid from the sample inlet) with independent actuation which allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (par. 0105-0106).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the fluid driving module comprising a singular pump of Lin to further include a second pump as taught by Huang because a first and second (syringe) pump with independent actuation allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (Huang, par. 0105-0106) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 25, Lin teaches at the terminal end of the fluidic channel is a chamber (discharge chamber) (see rightmost arrow in provided Lin, Fig. 6 above) for collecting fluid downstream the fluidic channel (Lin, Fig. 6; par. 0054) and an additional chamber (discharge chamber) (see chamber to the right of 11-1 in provided Lin, Fig. 6 above) that is at the start of the fluidic channel and is capable of holding fluid (Lin, par. 0041) (further comprising: a first discharged chamber and a second discharged chamber connected to opposite ends of the fluidic channel respectively). Examiner notes while both chambers are on the same side of the cartridge, the chambers are still on opposite ends of the fluidic channel that starts at the uppermost chamber and terminates at the lowermost chamber.
Lin teaches readout device 20 comprises fluid driving module 21 comprises pumping components to induce flow within the cartridge (par. 0032). Lin teaches such pumping components include a pump to engage fluid in the micro-channel structure to "to induce flow of the fluids in the flow paths defined in the micro-channel structure" (par. 0035) (a first pump… in fluid communication with the first discharged chamber).
Lin is silent to a second pump in fluid communication with… a second discharged chamber respectively.
Huang teaches a fluidic cartridge with a sensor array (Abstract). Huang teaches a biosensing cartridge 102 comprising an array of sensors 104 (Fig. 1; 0051-0052). Huang teaches the fluidic cartridge has a fluidic component/design having microfluidic channels and fluidic inlets for moving fluids from outside the platform to inside the biosensing chip platform (Fig. 1; par. 0051, 0054). Huang teaches each syringe pump 1202a/b are configured to hold different fluids (a first pump) (a second pump) with independent actuation which allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (par. 0105-0106).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the fluid driving module comprising a singular pump of Lin to further include a second pump as taught by Huang because a first and second (syringe) pump with independent actuation allows for the user to test multiple fluids through simply changing the syringe in the syringe pumping system (Huang, par. 0105-0106) with reasonable expectation of success. MPEP 2143(I)(G).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, et. al. (US 20230032773 A1; with prior publication date of 22 June 2022) as applied to claim 8, in view of Galen, et. al. (US 20210341360 A1).
Regarding claim 12, Lin teaches readout device 20 comprises an insertion slot 26 for inserting at least a portion of cartridge 10 (Fig. 2A).
Lin is silent to the device further comprising a lid pivotally connected to the housing and configured to rotate relatively to the fluidic cartridge module.
Galen teaches a diagnostic system using a cartridge and cartridge reader for biological sample analysis (Abstract). Galen teaches an embodiment of the cartridge reader comprising a housing 112 with a hinged lid 142 attached to an upper surface 150 (Fig. 1B; par. 0044-0045). The upper surface 150, covered by lid 142, hold an internal compartment 146 with a cartridge receptacle 114 (Fig. 1B; par. 0049). Including a lid with the cartridge reader allows for the cartridge receptacle to be easily accessed by a user while keeping the external environment out of the analysis area.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the housing of Lin to further include a hinged lid as taught by Galen. One would be motivated to do so because a lid allows for easy access the cartridge receptacle and prevents environmental contamination getting within the device, and this involves the simple combination of a housing with a cartridge insertion area (Lin) to further include a lid over the insertion area (Galen) to obtain a predictable results (a covered cartridge insertion area). MPEP 2143(I)(A).
Regarding claim 13, Lin teaches readout device 20 further comprises a display unit 25-1 (Fig. 2A, 2B) "configured to present audio/visual information of the detection results in user comprehensible format" (par. 0032) (screen disposed on the housing and electrically coupled to the processor).
Lin is silent to the display unit specifically comprising a touch screen.
Galen teaches a diagnostic system using a cartridge and cartridge reader for biological sample analysis (Abstract). Galen teaches an embodiment of the cartridge reader comprising a housing 112 with a display 116 like a touchscreen (Fig. 1B, par. 0050) (comprising a touch screen). Galen teaches incorporating a touchscreen within the cartridge reading device allows for the display of analysis results and an easy way for the user to input information into the reader (par. 0050).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the screen on the housing of Lin to specifically be a touch screen as taught by Galen. One would be motivated to do so because a touch screen allows for the display of analysis results and an easy way for the user to input information into the reader (Galen, par. 0050), and this involves the simple substitution of a non-touch screen display with touchscreen display to obtain predictable results (a device with improved user interface). MPEP 2143(I)(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jonson, et. al. (US 20140273187 A1) teaches a point of care system comprising a portable reader and a disposable cartridge, with fluidic channels with sensors, to be used with the reader for analyzing samples (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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