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
This is an office action in response to Applicant’s arguments and remarks filed on 12 December 2025. Claims 1-4, 7-15, and 21-26 are pending in the application. Claims 5 and 16-20 have been cancelled. Claims 21-26 have been newly added. Claims 1-4, 7-15, and 21-26 are being examined herein.
Status of Objections and Rejections
The rejection of claim 5 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) in view of Denomme, et. al. (WO 2021097582 A1) is withdrawn in view of the claim’s cancellation.
The rejections of claims 3, 6, and 7 under 35 U.S.C. § 112(b) are withdrawn in view of amendments.
The rejections of claims 1-3, 8-10, and 14 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) in view of Denomme, et. al. (WO 2021097582 A1) is withdrawn in view of amendments.
The rejections of claims 4 and 15 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) and Denomme, et. al. (WO 2021097582 A1) in further view of Yu, et. al. (US 20130236882 A1) is withdrawn in view of amendments.
The rejections of claims 6 and 7 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) and Denomme, et. al. (WO 2021097582 A1) in further view of Chang, et. al. (US 20190033252 A1) is withdrawn in view of amendments.
The rejection of claim 11 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) and Denomme, et. al. (WO 2021097582 A1) in further view of Miller, et. al. (US 20120142026 A1) is withdrawn in view of amendments.
The rejections of claims 12 and 13 under 35 U.S.C. § 103 in view of Huang, et. al. (US 20180203006 A1) and Denomme, et. al. (WO 2021097582 A1) in further view of Galen, et. al. (US 20210341360 A1) is withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see pages 9-11, filed 12 December 2025, with respect to the rejection of claims 1-15 under 35 U.S.C. § 103 have been fully considered and are persuasive. The rejection under 35 U.S.C. § 103 of claims 1-15 has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view Arlett, et. al. (US 20180021783 A1) and Arlett, et. al. (US 20180021783 A1) in view of Cumming, et. al. (US 20200292459 A1).
Applicant amended independent claims 1 and 8 to overcome rejections of record according to office action dated 12 September 2025.
Applicant offers to additional argument for claims 2-4, 6-7, and 9-15 outside of their dependence to claims 1 or 8.
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 10 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 10 recites the limitation "comprises a discharged chamber" in line 2 of the claim. Claim 8 from which claim 10 depends previously recites “a plurality of discharged chambers.” Examiner believes the singular discharged chamber of claim 10 is one of the plurality of discharged chamber of claim 8. Examiner recommends amending the claim to recite “comprises one of the plurality of discharged chambers” or an equivalent thereof.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 is dependent on claim 8 that recites, “a fluidic cartridge module disposed on the housing and comprising…a plurality of discharged chambers…and the plurality of discharged chambers are disposed at opposite ends of the fluidic channel and in fluid communication with the fluidic channel.” Claim 10 recites, “wherein the fluidic cartridge module further comprises a discharged chamber collecting fluids flowing through fluidic channel.” Because independent claim 8 previously recites a plurality of discharged chambers in communication with the fluidic channel, the singular discharge chamber in communication with the fluidic channel does not further limit the scope of claim 8. Examiner recommends amending or cancelling claim 10 since the amendments of claim 8 now encompass the limitation as set by claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 8-11, 13-15, 21, and 23-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arlett, et. al. (US 20180021783 A1).
Regarding claim 8, Arlett teaches a fluidic cartridge to be paired with a cartridge reader for running diagnostic tests on a sample (Abstract). Arlett teaches the fluidic cartridge 100 comprises:
Casing 111 with sample inlet 126 and apertures 122a-c to access blisters of blister sub-assembly 112 that hold buffers (Fig. 2-5; par. 0157, 0161, 0166) (a fluidic cartridge module disposed on the housing and comprising a sample inlet, a buffer inlet)
Electrode layer 117 with four sets of detection electrodes 166a-d, each set of detection electrodes 166a-d containing a reference electrode 171a-d (Fig. 3, 10; par. 0187) (a biosensor package comprising a sensor array) (and a reference electrode)
A fluidic layer 115 over electrode layer 117 (Fig. 3, 8A, 8B) and a pneumatic layer 114 over fluidic layer 115 (Fig. 3, 6A, 6B) (and a fluidic channel disposed over the biosensor package)
A series of chambers along the fluidic line including a waste chamber 137, mixing chamber 136, elution chambers 139, and amplification chambers 140a-b each located in different parts of the cartridge including waste chamber 137 and amplification chambers 140a-b at opposite ends (Fig. 6A-B, 8A-B; par. 0173) (a plurality of discharged chambers) (and the plurality of discharged chambers are disposed at opposite ends of the fluidic channel and in fluid communication with the fluidic channel)
Arlett teaches the plastic layer 135 of pneumatic layer 114 combines with fluidic layer 115 to form different recesses, chambers, and apertures for fluid movement including sample mixing chamber 136 connected to sample inlet 126 and apertures connecting the blisters through to the pneumatic 114 and fluidic 115 layer (Fig. 3, 6A-B, 8A-B; par. 0173, 0181-0182) (and a fluidic channel disposed over the biosensor package and connected to the sample inlet and the buffer inlet). Arlett additionally teaches detection chamber 141a-d that are open allowing liquid sample to come in contact with the electrode sets 166a-d (8A, 8B; par. 0215) and aperture 161 to additionally provide access to the electrode layer 117 (Fig. 8A, 8B; par. 0187) (wherein the fluidic channel comprises a first opening aligned with the sensor array and a second opening aligned with the reference electrode).
Arlett teaches the fluidic cartridge 100 is paired with a cartridge reader 200 comprising of outer housing 201 (Fig. 11A-B; par. 0235-0237) (a housing). Arlett teaches the cartridge reader 200 comprises six boards with a main board 220 providing overall control of the reader (Fig. 15; par. 0245-0246). Arlett teaches cartridge 10 comprises electrical interface 102 and when the cartridge 100 is plugged into reader 200 they become electrically connected (Fig. 39; par. 0355-0356) (a processor disposed in the housing electrically coupled to the fluidic cartridge module). Arlett teaches the control module of the reader 200 applies the potential difference across the electrodes of the cartridge meaning the control module of the reader 200 when paired with the electronic interface of the cartridge 100 is able to conduct a test using pulse voltammetry (par. 0357-0359) (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).
Regarding claim 9, Arlett teaches a first and second pump configures to supply positive and negative pressure respectively (par. 0015). Arlett teaches the pneumatic system comprises a pneumatic interface 144 within cartridge 100 that is controlled by reader 200 that actuates a series of bellows and valves to pump fluid through the system (par. 0174-0175). Arlett teaches the pneumatic system operates the bellows and valves to manipulate fluid flow through a system and regulating pressure through the whole system (par. 0340-0347).
Arlett teaches a first pneumatic system (a second pump) comprising bellows 20 and valves 22a-b that can pump the mixed sample downstream the fluidic pathway to detection chambers 62a-d (Fig. 1; par. 0118-0122, 0224) (a second 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). Arlett teaches a second pneumatic system (a first pump) comprising bellows 20 and valves 34, 36 that pump buffers 30, 32 into the main fluidic channel to the end of the fluidic channel (par. 0123) (a first 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).
Regarding claim 10, Arlett teaches series of chambers along the fluidic line including a waste chamber 137 to collect unwanted cell debris in the fluidic pathway (Fig. 6A-B, 8A-B; par. 0124, 0173) (wherein the fluidic cartridge module further comprises a discharged chamber collecting fluids flowing through fluidic channel).
Regarding claim 11, Arlett teaches course filters 18 downstream the sample mixing chamber 10 for capturing any unwanted cell debris before the sample moves downstream wherein the waste chamber 38 is fluidically connected (Fig. 1; par. 0120) (further comprising a filter disposed in the housing and in fluid communication with the discharged chamber for filtering the fluids from the discharged chamber).
Regarding claim 13, Arlett teaches reader 200 further comprises a touchscreen display 203 (mislabeled 208 in Figure 11A) with the touchscreen (233 in Figure 15) coupled to the main board (Fig. 11A, 15; par. 0237, 0246) (further comprising a touch screen disposed on the housing and electrically coupled to the processor).
Regarding claim 14, Arlett teaches the cartridge comprises electrical interface 102 that protrudes from housing 111 to be accessed by the reader 200 (Fig. 2; par. 0156, 0235); it can be seen in exploded Figure 3 the electrical interface belongs to electrode layer 117 from the cutouts on the corning from each layer and the aperture 161 in fluidic layer 115 (Fig. 3, 39; par. 0355) (and the substrate comprises an edge connector electrically connected to the biosensor chip and the processor).
While not explicitly disclosed, the electrode layer 117 which comprises electrode sets 166a-d, each serving as a biosensor chip, and electrical contacts 180, 182, 184 have to be attached to a substrate of sorts as these electrodes (biosensor chips) and electrical connectors cannot be floating in space (Fig. 10; par. 0215, 0351-0354) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Figure 10 is provided below with an arrow to indicate the larger outline discloses the outline of the substrate on which the electrical components are mounted.
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Regarding claim 15, Arlett teaches a plurality of electrode sets 166a-d, each serving as a biosensor chip, embedded in a substate of the electrode layer 117 (Fig. 10, par. 0212-0213) (wherein the biosensor package comprises a plurality of biosensor chips). Arlett teaches fluidic layer 115 comprises detection chambers 141a-d where the sample can come into contact with the electrode sets 166a-d (Fig. 8B; par. 0215) (the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively).
Regarding claim 21, Arlett teaches a fluidic cartridge to be paired with a cartridge reader for running diagnostic tests on a sample (Abstract). Arlett teaches the fluidic cartridge 100 comprises:
Casing 111 with sample inlet 126 and apertures 122a-c to access blisters of blister sub-assembly 112 that hold buffers (Fig. 2-5; par. 0157, 0161, 0166) (a casing comprising a sample inlet and a buffer inlet)
Electrode layer 117 with four sets of detection electrodes 166a-d, each set of detection electrodes 166a-d containing a reference electrode 171a-d (Fig. 3, 10; par. 0187) (a biosensor package in the casing and comprising a sensor array and a reference electrode)
A fluidic layer 115 over electrode layer 117 (Fig. 3, 8A, 8B) (a first channel frame disposed over the biosensor package)
A pneumatic layer 114 over fluidic layer 115 (Fig. 3, 6A, 6B) (a second channel frame disposed over the first channel frame)
Arlett teaches the plastic layer 135 of pneumatic layer 114 combines with fluidic layer 115 to form different recesses, chambers, and apertures for fluid movement including sample mixing chamber 136 connected to sample inlet 126 and apertures connecting the blisters through to the pneumatic 114 and fluidic 115 layer (Fig. 3, 6A-B, 8A-B; par. 0173, 0181-0182) (wherein the first channel frame and the second channel frame jointly form a fluidic channel connected to the sample inlet and the buffer inlet). Arlett additionally teaches detection chamber 141a-d that are open allowing liquid sample to come in contact with the electrode sets 166a-d (8A, 8B; par. 0215) and aperture 161 to additionally provide access to the electrode layer 117 (Fig. 8A, 8B; par. 0187) (wherein the first channel frame comprises a first opening aligned with the sensor array and a second opening aligned with the reference electrode). Arlett teaches cartridge 100 comprises a series of channels connecting the sample inlet 126 and blisters through the plurality of layers through different mechanical actuation steps until the sample reaches the detection chambers (Fig. 1; par. 0221-0231). Figures 6A and 6B shows the fluidic channel with a series of valves and bellows in pneumatic layer 115 (par. 0172-0176) (and the second channel frame comprises a channel groove connected to the sample inlet and the buffer inlet and passing through the first opening and the second opening).
Regarding claim 23, Arlett teaches a series of chambers along the fluidic line including a waste chamber 137, mixing chamber 136, elution chambers 139, and amplification chambers 140a-b each located in different parts of the cartridge including waste chamber 137 and amplification chambers 140a-b at opposite ends (Fig. 6A-B, 8A-B; par. 0173) (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).
Regarding claim 24, Arlett teaches a first and second pump configures to supply positive and negative pressure respectively (par. 0015). Arlett teaches the pneumatic system comprises a pneumatic interface 144 within cartridge 100 that is controlled by reader 200 that actuates a series of bellows and valves to pump fluid through the system (par. 0174-0175). Arlett teaches the pneumatic system operates the bellows and valves to manipulate fluid flow through a system and regulating pressure through the whole system (par. 0340-0347).
Arlett teaches a first pneumatic system (a second pump) comprising bellows 20 and valves 22a-b that can pump the mixed sample downstream the fluidic pathway to detection chambers 62a-d (Fig. 1; par. 0118-0122, 0224) (a second 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). Arlett teaches a second pneumatic system (a first pump) comprising bellows 20 and valves 34, 36 that pump buffers 30, 32 into the main fluidic channel to the end of the fluidic channel (par. 0123) (a first 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).
Regarding claim 25, Arlett teaches a series of chambers along the fluidic line including a waste chamber 137, mixing chamber 136, elution chambers 139, and amplification chambers 140a-b each located in different parts of the cartridge including waste chamber 137 and amplification chambers 140a-b at opposite ends (Fig. 6A-B, 8A-B; par. 0173) (a first discharged chamber and a second discharged chamber connected to opposite ends of the fluidic channel respectively).
Arlett teaches a first and second pump configures to supply positive and negative pressure respectively (par. 0015). Arlett teaches the pneumatic system comprises a pneumatic interface 144 within cartridge 100 that is controlled by reader 200 that actuates a series of bellows and valves to pump fluid through the system (par. 0174-0175). Arlett teaches the pneumatic system operates the bellows and valves to manipulate fluid flow through a system and regulating pressure through the whole system (par. 0340-0347). Arlett teaches a first pneumatic system (a first pump) comprising bellows 20 and valve 44 manipulating fluid movement into waste chamber 38 (the first discharged chamber) and a second pneumatic system (a second pump) comprising bellows 20 and valves, 50, 58a-b manipulating fluid to the amplification chambers (the second discharged chamber) (Fig. 1; par. 0224-0229) (a first pump and a second pump in fluid communication with the first discharged chamber and a second discharged chamber respectively).
Regarding claim 26, Arlett teaches course filters 18 downstream the sample mixing chamber 10 for capturing any unwanted cell debris before the sample moves downstream wherein the waste chamber 38 is fluidically connected (Fig. 1; par. 0120) (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).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-7, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Arlett, et. al. (US 20180021783 A1) in view of Cumming, et. al. (US 20200292459 A1).
Regarding claim 1, Arlett teaches a fluidic cartridge to be paired with a cartridge reader for running diagnostic tests on a sample (Abstract). Arlett teaches the fluidic cartridge 100 comprises:
Casing 111 with sample inlet 126 and apertures 122a-c to access blisters of blister sub-assembly 112 that hold buffers (Fig. 2-5; par. 0157, 0161, 0166) (a casing comprising a sample inlet and a buffer inlet)
Electrode layer 117 with four sets of detection electrodes 166a-d, each set of detection electrodes 166a-d containing a reference electrode 171a-d (Fig. 3, 10; par. 0213) (a biosensor package disposed in the casing and comprising a sensor array and a reference electrode)
A fluidic layer 115 over electrode layer 117 (Fig. 3, 8A, 8B) (a first channel frame disposed over the biosensor package)
A pneumatic layer 114 over fluidic layer 115 (Fig. 3, 6A, 6B) (a second channel frame disposed over the first channel frame)
Arlett teaches the plastic layer 135 of pneumatic layer 114 combines with fluidic layer 115 to form different recesses, chambers, and apertures for fluid movement including sample mixing chamber 136 connected to sample inlet 126 and apertures connecting the blisters through to the pneumatic 114 and fluidic 115 layer (Fig. 3, 6A-B, 8A-B; par. 0173, 0181-0182) (wherein the first channel frame and the second channel frame jointly form a fluidic channel connected to the sample inlet and the buffer inlet). Arlett additionally teaches detection chamber 141a-d that are open allowing liquid sample to come in contact with the electrode sets 166a-d (8A, 8B; par. 0215) (wherein the first channel frame comprises a first opening aligned with the sensor array) and aperture 161 to additionally provide access to the electrode layer 117 (Fig. 8A, 8B; par. 0187) (a second opening aligned with the reference electrode).
Arlett is silent to a concave disposed on a lower surface of the first channel frame for accommodating a biosensor chip of the biosensor package.
Cumming teaches a biosensing chip with multiple sensing modalities (Abstract). Cumming teaches the chip 102 is mounted on a carrier 101 and over the chip is an epoxy layer 103 (Fig. 2; par. 0052). Analysis of sample 105 occurs on strip 104 between the epoxy layer 103 and the chip 102 (Fig. 2; par. 0052). In order for the strip 104 to access the chip under epoxy layer 103, the interior of epoxy layer 103 must have a space between the chip and bottom surface of the epoxy layer. Further, Figure 2 shows the edges of epoxy layer 103 are flush against carrier 101 and the area above the chip of the epoxy layer 103 is hollow (and a concave disposed on a lower surface of the first channel frame for accommodating a biosensor chip of the biosensor package). Cumming teaches the epoxy layer 103 further provides protection of the electrical components of the chip and carrier (par. 0052).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the lower surface of fluidic layer of Arlett with have a concaved surface as taught by Cumming in order to fully protect the chip and corresponding components while still allowing space for sample analysis to occur. Because both systems use at least one covered, biosensing chip on a substrate, modifying the surface facing the chip to be concave as provided by Cumming, provided likewise sought functionality with reasonable expectation of success. MPEP 2143 (I)(G).
Regarding claim 2, modified Arlett teaches the fluidic cartridge further comprises waste chamber 137 (Fig. 6A-B; par. 0173) (wherein the fluidic cartridge module further comprises a discharged chamber collecting fluids flowing through fluidic channel).
Regarding claim 3, modified Arlett teaches the cartridge comprises electrical interface 102 that protrudes from housing 111 to be accessed by the reader 200 (Fig. 2; par. 0156, 0235); it can be seen in exploded Figure 3 the electrical interface belongs to electrode layer 117 from the cutouts on the corning from each layer and the aperture 161 in fluidic layer 115 (Fig. 3, 39; par. 0355) (and the substrate comprises an edge connector electrically connected to the biosensor chip and a processor).
While not explicitly disclosed, the electrode layer 117 which comprises electrode sets 166a-d, each serving as a biosensor chip, and electrical contacts 180, 182, 184 have to be attached to a substrate of sorts as these electrodes (biosensor chips) and electrical connectors cannot be floating in space (Fig. 10; par. 0215, 0351-0354) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Figure 10 is provided below with an arrow to indicate the larger outline discloses the outline of the substrate on which the electrical components are mounted.
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Regarding claim 4, modified Arlett teaches a plurality of electrode sets 166a-d, each serving as a biosensor chip, embedded in a substate of the electrode layer 117 (Fig. 10, par. 0212-0213) (wherein the biosensor package comprises a plurality of biosensor chips). Arlett teaches fluidic layer 115 comprises detection chambers 141a-d where the sample can come into contact with the electrode sets 166a-d (Fig. 8B; par. 0215) (the fluidic channel comprises a plurality of first openings aligned with a plurality of sensor arrays of the plurality of biosensor chips respectively).
Regarding claim 6, modified Arlett teaches cartridge 100 comprises a series of channels connecting the sample inlet 126 and blisters through the plurality of layers through different mechanical actuation steps until the sample reaches the detection chambers (Fig. 1; par. 0221-0231). Figures 6A and 6B shows the fluidic channel with a series of valves and bellows in pneumatic layer 115 (par. 0172-0176) (wherein the second channel frame comprises a channel groove connected to the sample inlet and the buffer inlet and passing through the first opening and the second opening).
Regarding claim 7, while not explicitly disclosed, modified Arlett teaches the electrode layer 117 which comprises electrode sets 166a-d, each serving as a biosensor chip, and electrical contacts 180, 182, 184 have to be attached to a substrate of sorts as these electrodes (biosensor chips) and electrical connectors cannot be floating in space (Fig. 10; par. 0215, 0351-0354) (wherein the biosensor package further comprises a substrate and the biosensor chip mounted on the substrate). Figure 10 is provided above with an arrow to indicate the larger outline discloses the outline of the substrate on which the electrical components are mounted.
Regarding claim 22, Arlett teaches the limitation as applied to claim 21 (see above). While not explicitly disclosed, Arlett teaches the electrode layer 117 which comprises electrode sets 166a-d, each serving as a biosensor chip, and electrical contacts 180, 182, 184 have to be attached to a substrate of sorts as these electrodes (biosensor chips) and electrical connectors cannot be floating in space (Fig. 10; par. 0215, 0351-0354) (wherein the biosensor package further comprises a substrate and a biosensor chip mounted on the substrate). Figure 10 is provided below with an arrow to indicate the larger outline discloses the outline of the substrate on which the electrical components are mounted.
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Arlett is silent to the first channel frame further comprising a concave disposed on a lower surface of the first channel frame for accommodating the biosensor chip.
Cumming teaches a biosensing chip with multiple sensing modalities (Abstract). Cumming teaches the chip 102 is mounted on a carrier 101 and over the chip is an epoxy layer 103 (Fig. 2; par. 0052). Analysis of sample 105 occurs on strip 104 between the epoxy layer 103 and the chip 102 (Fig. 2; par. 0052). In order for the strip 104 to access the chip under epoxy layer 103, the interior of epoxy layer 103 must have a space between the chip and bottom surface of the epoxy layer. Further, Figure 2 shows the edges of epoxy layer 103 are flush against carrier 101 and the area above the chip of the epoxy layer 103 is hollow (and a concave disposed on a lower surface of the first channel frame for accommodating a biosensor chip of the biosensor package). Cumming teaches the epoxy layer 103 further provides protection of the electrical components of the chip and carrier (par. 0052).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the lower surface of fluidic layer of Arlett with have a concaved surface as taught by Cumming in order to fully protect the chip and corresponding components while still allowing space for sample analysis to occur. Because both systems use at least one covered, biosensing chip on a substrate, modifying the surface facing the chip to be concave as provided by Cumming, provided likewise sought functionality with reasonable expectation of success. MPEP 2143 (I)(G).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Arlett, et. al. (US 20180021783 A1) in view of Galen, et. al. (US 20210341360 A1).
Regarding claim 12, Arlett teaches the limitations as applied to claim 8 (see above). Arlett teaches reader 200 further comprises cartridge drawer 202 to insert the cartridge 100 into the reader 200 (Fig. 11A, par. 0237). Cartridge drawer 202 has a front portion 250 and a drawer spring 258 that biases the drawer into an open position (Fig. 17A-B; par. 0237) (further comprising a lid).
Arlett is silent to 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) (further comprising a lid pivotally connected to the housing and configured to rotate relatively to the fluidic cartridge module). 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 modify the housing of modified Huang to include a hinged lid as taught by Galen in order to easily access the cartridge receptacle and prevent environmental contamination within the device. Because both devices deal with an analysis cartridge in use with a larger cartridge-reading housing, modifying the housing to include a hinged lid as provided by Galen, provided likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758