CTNF 18/288,356 CTNF 95459 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restriction During a telephone conversation with Matthew Jorge on 03/26/2026 and 03/27/2026 a provisional election was made to prosecute the invention of Group I, claims 1, 4, 12-13, 15-18, 20, 22-29, 33, and 44 , and to withdraw claim 34 . The Examiner deeply thanks Matthew Jorge for his patience and the telephone conversation. However, the intended restriction is now withdrawn, see remarks below. The Examiner realized after the telephone conversation: the telephonic election was not made indicating with or without traverse; and the telephonic election cannot be made without a Power of Attorney filed (see below): Telephone restriction practice is not permitted because it appears applicant has legal representation but a valid power of attorney has not been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 et seq. Therefore, any telephone restriction is withdrawn in favor of this Office Action. Information Disclosure Statement The information disclosure statement (IDS) was submitted on: 10/25/2023 Accordingly, the information disclosure statement is being considered by the examiner. Specification 07-29-04 Regarding the instant specification , paragraph [0009], the disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. 07-29 AIA The disclosure is objected to because of the following informalities: Regarding the instant specification , paragraph [0036], the term “hingably” should be “hingedly”. Regarding the instant specification , paragraph [0078], the term “hingabely” should be “hingedly”. Regarding the instant specification , paragraph [0088], the term “hingably” should be “hingedly”. Regarding the instant specification , paragraph [00995], the term “pump116” should be “pump 116”. Regarding the instant specification , the use of the term, “Blu-ray” in paragraph [0100], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 4 and 26 are objected to because of the following informalities: Regarding claim 4 , line 1, the term “clam 1” should be “claim 1”. Regarding claim 26 , line 1, the term “hingably” should be “hingedly” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 34 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. Regarding claim 34 , it is unclear if the claim intends to claim a testing device, a consumable, or a system. These are three different inventions in a single claim, and therefore, the claim is unclear and indefinite. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 12-13, 15, and 17 are rejected under 35 U.S.C. 102( a)(1) and 102(a)(2 ) as being anticipated by Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) . Regarding claim 1 , Azimi discloses a testing device (paragraph [0066] “a microfluidic test module”), comprising: a sample chamber to receive a sample (paragraph [0291] “the sample inlet 68”; Fig. 5); a reagent reservoir containing a reagent used to determine a presence of a target molecule in the sample (paragraph [0324] “chemical lysis reagent reservoir 56 being used to add the first amplification mix of primers, dNTPs and buffer and reagent reservoir 58 being used for adding the reverse transcriptase and/or polymerase. A chemical lysis reagent can also be added to the reservoir 56 along with the amplification mix”; Fig. 4); a sample fluidic line (Fig. 4 has a horizontal line in the schematic denoting a sample flow through a line), a reagent fluidic line (Fig. 4, a similar line as above, but from reagent reservoir 58), and a common fluidic line (Fig. 4, a similar line as above, but has a common line after mixing point 132), the sample fluidic line being fluidically coupled to the sample chamber and the common fluidic line (Fig. 4) and the reagent fluidic line being fluidically coupled to the reagent reservoir and to the common fluidic line (Fig. 4); and a diagnostic indicator coupled to the common fluidic line (Fig. 4 for the common fluidic line that leads to hybridization chambers 110; paragraph [0350] “FRET probes … The photodiode is incorporated for detection of fluorescence resulting from the hybridization of a target nucleic acid sequence or protein”), wherein the sample and the reagent flow through the respective sample fluidic line and the reagent fluidic line toward the common fluidic line and form a mixture within the common fluidic line (Fig. 4; lines converge at 132 to mix together in a common line) and wherein the common fluidic line enables a threshold incubation period of the mixture prior to the mixture flowing to the diagnostic indicator (paragraph [0319] “preset amplification time to amplify sufficient target DNA” and paragraph [0342] “The incubation section 114 has a single, heated incubation microchannel 210 etched in a serpentine pattern in the MST channel layer 100 from the downtake opening 134 to the boiling-initiated valve 106” and “These valves arrest the flow to retain the target cells in the heated incubation or amplification microchannels 210 or 158 while mixing, incubation and nucleic acid amplification takes place. The serpentine pattern of the microchannels also facilitates (to some extent) mixing of the target cells with reagents”). PNG media_image1.png 594 892 media_image1.png Greyscale Azimi, Fig. 4 PNG media_image2.png 503 982 media_image2.png Greyscale Azimi, Fig. 5 Regarding claim 12 , Azimi discloses wherein the common fluidic line is at least one of sized or shaped to enable the threshold incubation period (paragraph [0319] “preset amplification time to amplify sufficient target DNA” and paragraph [0342] “the amplification section 112 has a heated amplification microchannel 158 in a serpentine configuration”). Regarding claim 13 , Azimi discloses wherein the common fluidic line comprises a serpentine channel that enables the threshold incubation period (paragraph [0319] “preset amplification time to amplify sufficient target DNA” and paragraph [0342] “the amplification section 112 has a heated amplification microchannel 158 in a serpentine configuration”). Regarding claim 15 , Azimi discloses wherein the common fluidic line comprises a passive mixer (paragraph [0315] “the flow unpins the menisci at the surface tension valve 132 at the start of the mixing section 131. The mixture flows the length of the mixing section 131 for diffusion mixing”). Regarding claim 17 , Azimi discloses further comprising a heater positioned to heat one or more of the sample fluidic line, the reagent fluidic line, or the common fluidic line (paragraphs [0343] and [0346] “In the incubation section 114 and the amplification section 112, the sample cells and the reagents are heated by the heaters 154 controlled by the CMOS circuitry 86 using pulse width modulation (PWM). Each meander of the serpentine configuration of the heated incubation microchannel 210 and amplification microchannel 158 has three separately operable heaters 154 extending between their respective heater contacts 156 (see FIG. 14)”; see also, paragraph [0316] and [0339]-[0340]; and, Fig. 4, elements 126, 106, and 108 are boiling-initiated valves that heat the common fluidic line “the microchannel 210 upstream of the boiling-initiated valve 106”). Claim Rejections - 35 USC §§ 102 | 103 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. Claim 4 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1; or, in the alternative, under 35 U.S.C. 103 as obvious over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1, in view of Gorman (US 20140073013) (newly cited). Regarding claim 4 , Azimi discloses wherein the reagent comprises one or more of a Loop-mediated Isothermal Amplification (LAMP) reagent, a polymerase chain reaction (PCR) reagent, a lysis reagent, a primer reagent, a polymerase reagent, a deoxynucleotide triphosphate (dNTPs) reagent, dry reagent, liquid reagent, and a buffer reagent (paragraphs [0024]-[0030] and [0373]-[0375] “PCR”; paragraphs [0044] and [0377] “LAMP … DNA polymerase … and four specially designed primers”; paragraph [0324] “chemical lysis reagent reservoir 56 being used to add the first amplification mix of primers, dNTPs and buffer and reagent reservoir 58 being used for adding the reverse transcriptase and/or polymerase. A chemical lysis reagent can also be added to the reservoir 56 along with the amplification mix”; liquid reagents are inherently implied in paragraphs [0347] “diffusive mixing of any reagents with the sample fluid” and “diffusion of one liquid into the other” ; Fig. 4). Regarding the limitation “dry reagent”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time. Nevertheless, Gorman discloses a dry reagent and a liquid reagent (paragraphs [0110]-[0120]). In the analogous art of ultrafast thermal cyclers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi with the liquid reagent of Gorman in order to pipette in liquid-phase materials or let them flow in through microfluidic means (Gorman, paragraph [0110]); or, in the case of the dry reagents of Gorman, the solid-phase materials would be more storage stable and temperature stable in the microfluidic device (Gorman, paragraph [0111]). Claims 20 and 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 17; or, in the alternative, under 35 U.S.C. 103 as obvious over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 17. Regarding claim 20 , Azimi discloses further comprising the heater is positioned to heat at least a portion of the common fluidic line (paragraph [0316] and [0339]-[0340]; and, Fig. 4, elements 126, 106, and 108 are boiling-initiated valves that heat the common fluidic line “the microchannel 210 upstream of the boiling-initiated valve 106”). Arguably, Azimi discloses the heater is positioned to heat at least a portion of the sample fluidic line, a portion of the reagent fluidic line, and a portion of the common fluidic line (paragraph [0343] “In the incubation section 114 and the amplification section 112, the sample cells and the reagents are heated by the heaters 154 controlled by the CMOS circuitry 86 using pulse width modulation (PWM)”). Alternatively, this is an obvious re-arrangement of parts. Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the heater to be positioned to heat the sample line, the reagent line and the common line in order to keep nucleic acids at relevant biological temperatures during incubation of the sample and reagents, as well as heating the nucleic acids to various degrees during amplification. Regarding claim 22 , Azimi discloses further comprising a first heater (paragraph [0343] “three separately operable heaters); and, a second heater (paragraph [0343] “three separately operable heaters) positioned to heat a portion of the common fluidic line (paragraph [0316] and [0339]-[0340]; and, Fig. 4, elements 126, 106, and 108 are boiling-initiated valves that heat the common fluidic line “the microchannel 210 upstream of the boiling-initiated valve 106”). Arguably, Azimi discloses a first heater positioned to heat at least a portion of the sample fluidic line (paragraph [0343] “In the incubation section 114 and the amplification section 112, the sample cells and the reagents are heated by the heaters 154 controlled by the CMOS circuitry 86 using pulse width modulation (PWM)”). Alternatively, this is an obvious re-arrangement of parts. Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the heater to be positioned to heat the sample line, the reagent line and the common line in order to keep nucleic acids at relevant biological temperatures during incubation of the sample and reagents, as well as heating the nucleic acids to various degrees during amplification. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 15, in view of Njoroge (US 20140087359) (previously cited in the ISR and Written Opinion of 10/25/2023) . Regarding claim 16 , Azimi discloses a passive mixer (paragraph [0315] “the flow unpins the menisci at the surface tension valve 132 at the start of the mixing section 131. The mixture flows the length of the mixing section 131 for diffusion mixing”). Azimi does not disclose a herringbone mixer. Njoroge discloses a herringbone mixer (paragraphs [0029]-[0030], Figs. 5 and 6). In the analogous art of microfluidic mixing channels, it would have been obvious to one skilled in the art before the effective filing date to modify the microchannel of Azimi with the herringbone mixer of Njoroge in order to mix the samples and/or reagents (Njoroge, paragraph [0028]) to lyse the samples effectively (Njoroge, paragraph [0019]) . 07-21-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 17, in view of Gorman (US 20140073013) (newly cited) . Regarding claim 18 , Azimi discloses the heater (paragraphs [0343] and [0346] “In the incubation section 114 and the amplification section 112, the sample cells and the reagents are heated by the heaters 154 controlled by the CMOS circuitry 86 using pulse width modulation (PWM). Each meander of the serpentine configuration of the heated incubation microchannel 210 and amplification microchannel 158 has three separately operable heaters 154 extending between their respective heater contacts 156 (see FIG. 14)”). Azimi does not disclose wherein the heater comprises at least one of thermoelectric tape or a flexible heater. Gorman discloses wherein the heater comprises at least one of thermoelectric tape (paragraphs [0011], [0122], and [0138] “an adhesive layer between the heater and sample”) or a flexible heater ([0008] “The heater may comprise a flexible circuit board”). In the analogous art of ultrafast thermal cyclers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi with an adhesive layered heater and/or flexible heater of Gorman in order to quickly heat a sample for PCR (Gorman, paragraphs [0075]-[0076]) . 07-21-aia AIA Claim s 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 17, in view of Haghgooie (US 20160107157) (newly cited) . Regarding claim 23 , Azimi discloses further comprising [urging] the sample (paragraphs [0288] and [0339] “capillary flow”) from the sample chamber toward the common fluidic line (paragraphs [0288] and [0340] “capillary driven flow continues along the amplification section exit channel”) and [urging] the reagent from the reagent reservoir toward the common fluidic line (paragraphs [0288] and [0375] “reagent channels” are designed by size for reagent mixture flow). Azimi does not disclose a pump. Haghgooie discloses a pump (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]). Regarding claim 24 , Azimi does not disclose wherein the pump comprises a piston pump. Haghgooie discloses a piston pump (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the piston pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]). Regarding claim 25 , Azimi does not disclose further comprising a body defining a bore, the piston pump comprising a piston and the bore, the piston being slidably disposed within the bore. Haghgooie discloses further comprising a body defining a bore (Fig. 2, element 112 “main sample collection well”), the piston pump comprising a piston (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger”) and the bore (Fig. 2, element 112 , the piston being slidably disposed within the bore (Fig. 2 “Depress plunger to separate blood sample”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the piston pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]) . 07-21-aia AIA Claim s 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) in view of Haghgooie (US 20160107157) (newly cited) as applied to claim 25, further in view of Lee-8364 (KR 20140068364) (Clarivate Analytics translation) (newly cited) . Regarding claim 26 , Azimi discloses a lid (paragraph [0288] “a cap overlaying the MST layer”). Azimi does not disclose further comprising a lid hingably coupled to the body and movable between an open position and a closed position, the lid to move the piston within the bore when the lid moves toward the closed position. Haghgooie discloses further comprising a lid hingably coupled to the body and movable between an open position and a closed position (paragraph [0058]). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to have a lid hingably coupled to the body and moveable between an open position and a closed position as in Haghgooie in order to seal the sample chamber for samples to remain uncontaminated (Haghgooie, paragraph [0058]). Lee-8364 discloses wherein the lid [moves] the piston within the bore when the lid moves toward the closed position (Figs. 2a-2d; pgs. 6 and 7 of 26). In the analogous art of microfluidic chips, it would have been obvious to one skilled in the art before the effective filing date to modify the device of modified Azimi to have the lid actuated piston, wherein the piston is moved by the hinged lid of Lee in order to pressurize a compartment in the microfluidic chip in order to transfer the sample fluid to another portion of the chip via microfluidic channels (Lee-8364, pg. 7 of 26, under the paragraph starting and ending with “The sample supplied … the reaction part 24, do.”). Regarding claim 27 , Azimi discloses wherein the sample chamber and the reagent reservoir comprise corresponding openings (paragraph [0291] Fig. 5, element 68 “sample inlet”; and paragraph [0297], Fig. 8, elements 54, 56, 58, 60, and 62 “reservoirs”) and wherein the seal seals against the reagent openings (paragraph [0296] “the upper seal layer 82 encloses the reservoirs”) when the lid (paragraph [0288]; Fig. 5, element 46 “cap 46 overlaying the MST layer 87”) is in the closed position (paragraph [0288]; Fig. 5, element 46 “cap 46 overlaying the MST layer 87”). Azimi does not disclose wherein the lid seals against the [sample chamber opening] when the lid is in the closed position to allow the sample chamber and the reagent reservoir to be pressurized by the piston pump. Haghgooie discloses wherein the lid seals against the [sample chamber opening] when the lid is in the closed position to allow the sample chamber and the reagent reservoir to be pressurized by the piston pump (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger” is part of element 104 “lid”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]). Regarding the limitation “to allow the sample chamber and the reagent reservoir to be pressurized by the piston pump”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Azimi would be fully capable of operating in this manner given its sample chamber, lid, and piston pump. Regarding claim 28 , Azimi discloses the sample chamber comprises a corresponding opening (paragraph [0291] Fig. 5, element 68 “sample inlet”); and, a lid (paragraph [0288]; Fig. 5, element 46 “cap 46 overlaying the MST layer 87”). Azimi does not disclose wherein the sample chamber comprises a corresponding opening and wherein the lid seals against the opening when the lid is in the closed position to allow the sample chamber to be pressurized by the piston pump. Haghgooie discloses wherein the sample chamber comprises a corresponding opening (paragraph [0059] and Fig. 2, element 112 “main sample collection well”) and wherein the lid seals against the opening when the lid is in the closed position (Figs. 1A-2) to allow the sample chamber to be pressurized by the piston pump (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger” is part of element 104 “lid”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]). Regarding the phrase “to allow the sample chamber to be pressurized by the piston pump”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Azimi would be fully capable of operating in this manner given its sample chamber, lid, and piston pump . 07-21-aia AIA Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1, in view of Kitaguchi (US 20050148091) (previously cited in the ISR and Written Opinion of 10/25/2023) . Regarding claim 29 , Azimi discloses further comprising a venting membrane covering an opening of the reagent reservoir (paragraphs [0296]-[0297] “the upper seal layer” seals reagent reservoirs “The five reservoirs 54, 56, 58, 60 and 62 are preloaded with assay-specific reagents”; and, paragraph [0306] “Vent holes 122 in the upper seal 82”). Azimi does not disclose a hydrophobic venting membrane. Kitaguchi discloses a hydrophobic venting membrane (abstract, paragraphs [0063]-[0066], [0189], and [0303]). In the analogous art of liquid feeding control devices and analyzing cartridges, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi with the hydrophobic venting membrane of Kitaguchi in order to use the hydrophobic holes as the vent, so only a gas is passed through the vent because the solution is not passed therethrough because of its surface tension, thus reducing possibilities that the liquid is leaked out (Kitaguchi, paragraph [0189]) . 07-21-aia AIA Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1 . Regarding claim 33 , Azimi discloses further comprising: a second reagent reservoir (paragraph [0297], Fig. 8, elements 54, 56, 58, 60, and 62 “reservoirs”); a second reagent used to determine a presence of a target molecule in the sample (paragraph [0386] “two antibodies 145 or two aptamers 141 that must independently bind to different non-overlapping epitopes or regions of the target protein 142”; or alternatively, paragraph [0034] “second pair of primers”); a second reagent fluidic line (Fig. 4, arrows leading from elements 60 and 62 “Reagent Reservoirs” denoting flow through lines), the sample fluidic line (Fig. 4 has a horizontal line in the schematic denoting a sample flow through a line). Arguably, Azimi discloses a second diagnostic indicator (paragraph [0386]-[0388] “different fluorophores or luminophores”). Azimi does not disclose: a second reagent reservoir containing a second reagent used to determine a presence of a second target molecule in the sample a second common fluidic line the sample fluidic line, being fluidically coupled to the sample chamber and the second common fluidic line and the second reagent fluidic line being fluidically coupled to the second reagent reservoir and to the second common fluidic line; and a second diagnostic indicator coupled to the second common fluidic line However, features 1-4 are considered obvious under duplication of parts. Regarding the limitations, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi with a second reagent reservoir containing a second reagent, a second common fluidic line, a connection between the second common fluidic line and the sample fluidic line, a connection between the second reagent reservoir and the second common fluidic line, and a second diagnostic indicator in order to quantify of a number of a second specific molecule in addition to the quantification of a number of a first specific molecule . 07-21-aia AIA Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1, in view of Haghgooie (US 20160107157) (newly cited) . Regarding claim 34 , Azimi discloses further comprising a consumable (paragraph [0237] “The test modules 10 and 11 are both single-use only for mass production and distribution in sterile packaging ready for use”) comprising the sample chamber (paragraph [0291] “the sample inlet 68”; Fig. 5), the reagent reservoir (paragraph [0324] “reagent reservoir 58 being used for adding the reverse transcriptase and/or polymerase”; Fig. 4), the sample fluidic line (Fig. 4 has a horizontal line in the schematic denoting a sample flow through a line), the reagent fluidic line (Fig. 4, a similar line as above, but from reagent reservoir 58), and the common fluidic line (Fig. 4, a similar line as above, but has a common line after mixing point 132) further comprising a system comprising: a receptacle to receive the consumable (paragraph [0238] “outer casing 13 has a macroreceptacle”); a heater positioned to heat one or more of the sample fluidic line, the reagent fluidic line, or the common fluidic line (paragraphs [0343] and [0346] “In the incubation section 114 and the amplification section 112, the sample cells and the reagents are heated by the heaters 154 controlled by the CMOS circuitry 86 using pulse width modulation (PWM). Each meander of the serpentine configuration of the heated incubation microchannel 210 and amplification microchannel 158 has three separately operable heaters 154 extending between their respective heater contacts 156 (see FIG. 14)”; see also, paragraph [0316] and [0339]-[0340]; and, Fig. 4, elements 126, 106, and 108 are boiling-initiated valves that heat the common fluidic line “the microchannel 210 upstream of the boiling-initiated valve 106”); and, [urging] the sample (paragraphs [0288] and [0339] “capillary flow”) from the sample chamber toward the common fluidic line (paragraphs [0288] and [0340] “capillary driven flow continues along the amplification section exit channel”) and [urging] the reagent from the reagent reservoir toward the common fluidic line (paragraphs [0288] and [0375] “reagent channels” are designed by size for reagent mixture flow). Azimi does not disclose a pump fluidically couplable to one or more of the sample chamber, the reagent reservoir, the sample fluidic line, or the reagent fluidic line. Haghgooie discloses a pump (paragraphs [0058] and [0060]; Figs. 1A-2, element 106 “plunger”) fluidically couplable to the sample chamber (paragraph [0059]; Figs. 1A-2, element 112 “the main sample collection well”). In the analogous art of disposable assay cartridges for specimens, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi to be driven by a pump as in Haghgooie in order to increase pressure within the device to drive the sample from its chamber into microfluidic channels (Haghgooie, paragraph [0060]); the pump can also be used to draw fluid back into the sample chamber (Haghgooie, paragraph [0065]). Regarding the limitation “to one or more of the sample chamber, the reagent reservoir, the sample fluidic line, or the reagent fluidic line”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time. Additionally, these limitations are disclosed above by Azimi . 07-21-aia AIA Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Azimi (US 20110312713) (previously cited in the ISR and Written Opinion of 10/25/2023) as applied to claim 1, in view of Gorman (US 20140073013) (newly cited) . Regarding claim 44 , Azimi discloses the sample fluidic line (Fig. 4 has a horizontal line in the schematic denoting a sample flow through a line), the reagent fluidic line (Fig. 4, a similar line as above, but from reagent reservoir 58), and the common fluidic line (Fig. 4, a similar line as above, but has a common line after mixing point 132). Azimi does not disclose further comprising a droplet generator comprising a fluidic line coupled to one or more of the sample fluidic line, the reagent fluidic line, and the common fluidic line. Gorman discloses further comprising a droplet generator (paragraph [0084] “generates one or more droplets”) comprising a fluidic line (paragraph [0084] “flow channels”). In the analogous art of ultrafast thermal cyclers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Azimi with the droplet generator and respective fluidic line of Gorman in order to distribute and partition nucleic acids among droplets rather than in a bulk fluid so that amplification reactions can be completed in the droplets for digital nucleic acid amplification reactions (paragraphs [0212] and [0164]). Regarding the limitation “coupled to one or more of the sample fluidic line, the reagent fluidic line, and the common fluidic line”, these features are already disclosed above by Azimi. The fluidic coupling of the lines is obvious due to the motivation statement given above. Additional Prior Art References 07-96 AIA The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure. Lee-1322 (US 20190181322) (previously cited in the ISR and Written Opinion of 10/25/2023) – This invention is about flexible thermoelectric tape and its use as an electrical power generator or cooling device. Abate (US 20150232942) (newly cited) – This invention is Applicant’s own work, but is prior art, pertaining to detecting biological compounds. Abate (US 20170121756) (newly cited) – This invention is Applicant’s own work, but is prior art, pertaining to PCR-activated sorting. Lee-8874 (US 20160228874) (newly cited) – This invention is by the Assignee, but is prior art, pertaining to digital fluid sample separation apparatuses and methods for one-step quantitative sample analysis. Lee-4318 (US 20170254318) (newly cited) – This invention is by the Assignee, but is prior art, pertaining to digital fluid sample separation apparatuses and methods for one-step quantitative sample analysis. Silverbrook (US 20110312856) (newly cited) – There are about 400 pre-grant publications or patents on this invention, directly related as a patent family to the above primary reference to this Office Action: Azimi (US 20110312713) (newly cited). Edwards (US 20160168624) (newly cited) – This invention contains a fluidic channel cartridge with a bellows for nucleic acid amplification. Taylor (US 20160175835) (newly cited) – This invention contains a fluidic channel cartridge with a bellows for nucleic acid amplification . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is (571)272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /N.G.E./Examiner, Art Unit 1799 /MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799 Application/Control Number: 18/288,356 Page 2 Art Unit: 1799 Application/Control Number: 18/288,356 Page 3 Art Unit: 1799 Application/Control Number: 18/288,356 Page 4 Art Unit: 1799 Application/Control Number: 18/288,356 Page 5 Art Unit: 1799 Application/Control Number: 18/288,356 Page 6 Art Unit: 1799 Application/Control Number: 18/288,356 Page 7 Art Unit: 1799 Application/Control Number: 18/288,356 Page 8 Art Unit: 1799 Application/Control Number: 18/288,356 Page 9 Art Unit: 1799 Application/Control Number: 18/288,356 Page 10 Art Unit: 1799 Application/Control Number: 18/288,356 Page 11 Art Unit: 1799 Application/Control Number: 18/288,356 Page 12 Art Unit: 1799 Application/Control Number: 18/288,356 Page 13 Art Unit: 1799 Application/Control Number: 18/288,356 Page 14 Art Unit: 1799 Application/Control Number: 18/288,356 Page 15 Art Unit: 1799 Application/Control Number: 18/288,356 Page 16 Art Unit: 1799 Application/Control Number: 18/288,356 Page 17 Art Unit: 1799 Application/Control Number: 18/288,356 Page 18 Art Unit: 1799 Application/Control Number: 18/288,356 Page 19 Art Unit: 1799 Application/Control Number: 18/288,356 Page 20 Art Unit: 1799 Application/Control Number: 18/288,356 Page 21 Art Unit: 1799 Application/Control Number: 18/288,356 Page 22 Art Unit: 1799 Application/Control Number: 18/288,356 Page 23 Art Unit: 1799 Application/Control Number: 18/288,356 Page 24 Art Unit: 1799