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 6/13/2025. Claims 1-24, and 44 are pending in the application with claims 25-41 remaining withdrawn.
Status of Objections and Rejections
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant’s arguments, see Pages 8-10, filed 6/13/2025, with respect to the rejections of claims 1-6, 15-16, 21-22, and 44-45 being rejected under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration and in light of the amendment made to claim 1, a new ground of rejection is made over Drese et al. (US 2010/0136699) in view of Cypes et al. (US 20080275653).
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 1-6, 15-16, 21-22, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Drese et al. (US 2010/0136699) in view of Cypes et al. (US 20080275653).
Regarding claim 1, Drese et al. teaches a system (sample plate 1, see Fig. 3 and [0085] and Abstract) comprising: a microfluidic device (sub-plates 2-4, see Fig. 3 and [0085]- [0088]) comprising:
a substrate (plates 2-4),
a reservoir defined in the substrate, wherein the reservoir is configured to store a fluid sample configured to be tested for the presence or absence of a compound (reaction zone 25 retains sample after injection, see Fig. 3-5 and [0095]),
the reservoir having a reservoir outlet (reaction zone 25 would necessarily have an outlet to channels, see Fig. 3-5 and [0095]); a microfluidic channel formed in the substrate, extending from the reservoir outlet of the reservoir to a channel outlet (channel 35 connects reaction zone 25 to waste reservoir 15 as an outlet, see Fig. 3-5 and [0095]- [0097]), wherein the microfluidic channel comprises:
a first portion fluidically connected to the outlet of the reservoir (35), a second portion connected to the channel outlet (34), and a detection portion arranged between the first portion and the second portion, wherein the detection portion is fluidically connected to the first portion and the second portion (analysis zone is located between channel 35 and channel 34, see Fig. 3-5 and [0095]- [0097]),
a microheater arranged adjacent to the reservoir, the microheater configured to heat the fluid sample to a temperature at which the fluid sample releases a byproduct in response to being heated (heating element 26 located next to reaction zone 25 where the heater is used to heat the sample to generate products, see [0095]),
and a detector arranged in the detection portion, wherein the detector is configured to indicate a presence or absence of the byproduct released from the heated sample (the analysis zone is used to detect a product of heating, see [0037] – [0038] and [0095]- [0098])
a controller operatively coupled to the microheater, the controller comprising:
one or more processors (micro-processors make up the control of the system, see [0050] – [0051]); and
a computer-readable medium storing instructions executable by the one or more processors to perform operations comprising:
transmitting an instruction to the microheater to cause the microheater to heat the reservoir to two temperatures (the processor contains instructions used to prompt the heater to heat to one temperature then heat to a second temperature, see [0048] - [0051]).
However, while Drese et al. teaches that the processor instructs the heater to heat to specific temperatures to elute fractions of a hydrocarbon sample (see [0051]), Drese et al. does not explicitly teach that the processor is explicitly transmitting an instruction to the microheater to cause the microheater to heat the reservoir to an autoignition temperature of about 200C to about 220C and prompting the microheater to heat the reservoir to a flashpoint temperature of about 55C to about 65C.
However, in the analogous art of microfluidic devices for detecting analytes from a fractionated fluid sample, Cypes et al. teaches a device wherein the controller prompts each microfluidic system to heat the sample to 208.4°C for ignition response testing and 60°C to perform flash vaporization (see [0053] and Example 4 with Table 2). Modifying a microfluidic device to heat to different temperatures to perform multi-stage separation of a hydrocarbon sample was known in the art before the effective filing date of the instant application as exemplified by Cypes et al. (see [0051] and [0053]) and Drese et al. (see [0037]), thereby making Drese et al. ready for improvement in the art.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the heater and process control means of Drese et al. to implement the heating profiles used to elute different fractions of the sample of Cypes et al. For the benefit of detecting different particulates in each phase of the sample following vaporization, see [0068] in Cypes et al. Further, the modification of the heater of Drese et al. to include the specific temperature scale as outlined by Cypes et al. would have yielded the predictable result of successfully heating a crude oil sample for flow fractionation and analysis as both inventions are drawn to the separation of a sample by heating.
Regarding claim 2, modified Drese et al. teaches the system of claim 1, wherein the microfluidic channel has a channel inlet that is fluidically coupled to the reservoir by the reservoir outlet of the reservoir (the channel 35 is connected to the reaction zone 25, see Figs. 3-5), and the channel outlet that is fluidically coupled to the detection portion by the second portion of the microchannel (fluid passes through the detection portion to the waste reservoir 15 via channel 34, see Fig. 3-5 and [0095] – [0098]).
Regarding claim 3, modified Drese et al. teaches the system of claim 1, wherein the byproduct released by the heated sample is configured to flow through the microfluidic channel (products released by the sample flow through the channel 35, see [0095]- [0098]).
Regarding claim 4, modified Drese et al. teaches the system of claim 3, wherein the byproduct released by the heated sample is a gaseous byproduct (the products released by the sample include vapors, see [0037] and [0095]).
The inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 5, modified Drese et al. teaches the system of claim 4, wherein the byproduct released by the heated sample is configured to flow through the detection portion of the microfluidic channel (vapors flow from reaction zone 25 to waste 15 which would include the analysis zone therebetween, see Fig. 3-5, [0037], and [0095]- [0098]).
Regarding claim 6, modified Drese et al. teaches the system of claim 4, wherein the byproduct released by the heated sample is configured to flow from an inlet of the microfluidic channel to the outlet of the microfluidic channel (generated product flows from the reaction zone 25 to waste 15, see Fig. 3-4, [0037]- [0038], and [0095] – [0098]).
Regarding claim 15, modified Drese et al. teaches the system of claim 1, wherein the operations of the controller (micro-processors make up the control of the system, see [0050] – [0051] in Drese et al.) comprise: transmitting the instruction to the microheater to cause the microheater to heat the reservoir to the autoignition temperature for about one second to about 15 minutes (the processor is used to prompt the heater to heat to one temperature then heat to a second temperature, see [0051], where the sample is heated for preconditioning for 5 minutes, see [0093]- [0094] in Drese et al.);
and prompting the microheater to heat the reservoir to the flashpoint a second temperature for about one second to about 10 minutes (sample is heated in reaction zone for 5 minutes, see [0095]).
Regarding claim 16, modified Drese et al. teaches the system of claim 1, wherein the operations further comprise detecting a predetermined level of a compound, based on a pH measurement or color change (the optical detector and processor are used to detect a change in wavelength, or color, see [0044]- [0048]).
Regarding claim 21, modified Drese et al. teaches the system of claim 1, the sample comprises a combustible compound having an autoignition temperature and a flashpoint temperature, wherein the microheater is configured to heat the sample to the autoignition temperature and to the flashpoint temperature (the sample comprises diesel, see [0068], which is a combustible compound).
The limitation: “combustible compound” is considered a material worked upon by an apparatus and does not patentably define the claimed apparatus over the prior art (see MPEP 2115), where the heater is configured to heat the sample to the autoignition temperature and to the flashpoint temperature (heating zone (microheater) vaporizes sample, see [0095] and [0037], where vaporizing the sample would necessarily include heating the sample to its flashpoint and auto-ignition temperature, see [0051] of the Instant Application.
Regarding claim 22, modified Drese et al. teaches the system of claim 21, wherein the combustible compound is diesel and the byproduct is carbon dioxide.
The limitations of “diesel,” “combustible compound,” and "carbon dioxide" are considered a material worked upon by an apparatus and do not patentably define the claimed apparatus over the prior art (see MPEP 2115). Carbon dioxide is a product of combustion and diesel is the sample being worked upon (see [0068] in Drese and [0034] in the Instant Specification).
Regarding claim 44, modified Drese et al. teaches the system according to claim 1, wherein the autoignition temperature is a temperature at which the fluid sample ignites and produces the byproduct in response to being heated (the sample is heated to vaporization, see [0037] – [0038]).
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Drese et al. (US 2010/0136699) as applied to claim 1 above, and further in view of Nishimura et al. (US 2002/0137229 A1).
Regarding claim 7, modified Drese et al. teaches the system according to claim 1, comprising a microheater (heaters 26 used to heat reaction zone), but does not teach that the heater is arranged in the reservoir.
However, in the analogous art of microfluidic devices for chemical analysis, Nishimura et al. teaches a microheater arranged within a reservoir (thermal resistor 62 within gas generator 60 (reservoir), see Fig. 4 and [0033]).
It would have been obvious to a person having skill in the art before the effective filing date of the instant application to have modified the device of Drese et al. to place the resistive microheater within the reservoir, as demonstrated by Nishimura et al. for the benefit of directly heating a sample liquid to its gaseous state for transport along the microfluidic chip (see [0015] in Nishimura et al.). Further, the modification of the device of Drese et al. to include placing the micro-heater within the microfluidic sub-plate’s chamber, as shown by Nishimura et al., would have had a reasonable expectation of successfully generating a vapor byproduct within the reaction zone (reservoir) that is released and subsequently analyzed a detector, such as the UV/NIR detector located within the microfluidic detection system of Drese et al.
Claims 8-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Drese et al. (US 2010/0136699) as applied to claim 1 above, and further in view of Burdick (US 2281746).
Regarding claim 8, modified Drese et al. teaches the system of claim 1, comprising a detector (UV/NIR analysis zone), but does not teach that the detector comprises a pH detection medium. However, in the analogous art of detecting compounds within a sample that is turned into a gas, Burdick teaches a system (referred to as an apparatus, see Page 1, Col. 1, Lines 1-7) comprises a pH detection medium (referred to as the pH indicator solution, see Page 2, Col. 1, Lines 35-43)
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the pH indicator solution (indicator medium) of Burdick for the benefit of providing an indication of a change of pH within the gas produced by a heating process, which may correlate to a concentration of an unwanted contaminant in the sample (see Page 1, Col. 1, Lines 8-16 of Burdick). The modification of the analysis zone comprising a reactant to include a pH indicator as shown by Burdick would have had a reasonable expectation of facilitating a more obvious visual or color response of a detector to indicate that the detector has been exposed to a target gas.
Regarding claim 9, the combination of Drese et al. and Burdick teaches the system of claim 8, wherein Drese et al. teaches an analysis zone, but does not teach that the detector is a pH detection medium that is configured to indicate a change in pH by a visual change.
However, Burdick teaches that the pH detection medium is configured to indicate a change in pH by a visual change (the indicator solution indicates a change in pH by exhibiting a color change (visual change) of blue to yellow in more acidic environments, see Page 2, Col. 1, Lines 35-43).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the pH indicator solution that comprises a dye (indicator medium) of Burdick for the benefit of providing a more obvious visual indication of a change of a property, specifically the pH, within the gas produced by a heating process, which may correlate to a concentration of an unwanted contaminant in the gas (see Page 1, Col. 1, Lines 8-16 of Burdick). The modification of the analysis zone of Drese et al. to include the pH-responsive color change of Burdick would have had a reasonable expectation of facilitating a visual response of the detector to indicate that the detector has been exposed to a target gas.
Regarding claim 10, the combination of Drese and Burdick teaches the system of claim 9, wherein modified Drese et al. teaches an indicator (pH indicator of Burdick). Modified Drese additionally teaches that the visual change is a color change (the indicator solution changes color from yellow to blue, see Page 2, Col. 1, Lines 35-43 of Burdick).
Regarding claim 11, the previously modified combination of Drese et al. and Burdick teaches the system of claim 8, but does not teach that the indicating solution comprises bicarbonate.
However, the established analogous art of Burdick teaches that the pH detection medium is a bicarbonate indicator solution (the indicator solution (pH detection medium) comprises sodium bicarbonate as a main ingredient, and is therefore a bicarbonate indicator solution, see Page 2, Col. 1, Lines 47-57).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the indicator solution of previously modified Drese et al. to include the sodium bicarbonate indicator solution (bicarbonate indicator solution) of Burdick for the benefit of providing a liquid absorbent for the target gas within the solution (see Page 3, Col. 2, Lines 43-61). The modification of the analysis zone to include the bicarbonate indicator solution of Burdick would have had a reasonable expectation of providing an indicating solution that absorbs the target analyte within a solution and allows for subsequent analysis.
Regarding claim 17, modified Drese et al. teaches the system of claim 1, wherein the operations further comprise prompting an imaging subsystem to analyze a color or color change exhibited; and detecting a predetermined level of a compound, based on the color or color change (the optical detector and processor are used to detect the target analyte based on change in wavelength, or color, see [0044]- [0051]).
Inclusion of the material or article worked upon by a structure, specifically the detection medium, being claimed does not impart patentability to the claims. In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Drese et al. does not explicitly teach that the detector is a pH detection medium; however, the analogous art of Burdick teaches that the pH detection medium is configured to indicate a change in pH by a visual change (the indicator solution indicates a change in pH by exhibiting a color change (visual change) of blue to yellow in more acidic environments, see Page 2, Col. 1, Lines 35-43).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the pH indicator solution that comprises a dye (indicator medium) of Burdick for the benefit of providing a more obvious visual indication of a change of a property, specifically the pH, within the gas produced by a heating process, which may correlate to a concentration of an unwanted contaminant in the gas (see Page 1, Col. 1, Lines 8-16 of Burdick). The modification of the analysis zone of Drese et al. to include the pH-responsive color change of Burdick would have had a reasonable expectation of facilitating a visual response of the detector to indicate that the detector has been exposed to a target gas.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Drese et al. (US 2010/0136699) as applied to claim 1 above, and further in view of Sparks et al. (US 20090075129).
Regarding claim 12, modified Drese et al. teaches the system of claim 1, a detection portion (analysis zone) of the microfluidic channel (channel 35 to channel 34), but does not teach that the detection portion comprises a U-shaped section. However, in the analogous art of platforms for sensing an analyte within a gas formation (see Abstract) Sparks teaches a microfluidic device comprising a U-shaped section (the tube 14 (microfluidic channel) comprises a curved segment 16A (U-shaped section), see Fig. 13 and [0041]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date to have modified the detection portion (analysis zone) of Drese et al. to include the U-shaped section of Sparks for the benefit of altering the fluid flow of the gas within the channel to determine a number of properties within the gas sample such as density, flow rate, or volume, which would aid in the detection of a gas within the device (see [0010]- [0012] in Sparks). The modification of the channel of Drese et al. to include the U-shaped sections of Sparks would have a reasonable expectation of facilitating portions of the channel for detection of different fluid properties along different sections of the channel.
Regarding claim 13, the combination of Drese et al. and Sparks teaches the system of claim 12, wherein Drese et al. teaches the detector (analysis zone comprising the optical detector), but does not teach that the detector is arranged adjacent to the U-shaped section.
However, Sparks teaches that the detector is arranged adjacent to the U-shaped section (the sensing electrode 24 (detector) is arranged next to the curved segment 16A (U-shaped section), see Fig. 13 and [0041]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the system of Drese et al. to include the detector adjacent to the U-shaped section of the fluidic channel for the benefit of monitoring gas concentrations without having to enter the system and interfere with test readings by introducing foreign gases into the system. The modification of placing the optical detector of Drese et al. adjacent to the U-shaped section of Sparks would have a reasonable expectation of facilitating fluid analysis based on detected properties of the fluid sample such as temperature or pH due to its proximity to the sample.
Regarding claim 14, the combination of Drese et al. and Sparks teaches the system of claim 12, wherein Drese et al. teaches a detector (analysis zone and optical detector), but does not teach that the detector is arranged within the U-shaped section. However, Sparks teaches a microfluidic device wherein the detector is arranged in the U-shaped section (the sensing electrode 22 (detector) is located on the curved, or U-shaped, section of the tube 20 see Fig. 9 and [0005]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the detector (analysis zone and optical detector of Drese et al.) to have been located within the U-shaped section as described by Sparks for the benefit of measuring the fluid properties located at the curved section of the fluidic channel such as flow rate, density, or volume, which aid in the detection of a target gas species (see [0010]- [0012] in Sparks). The modification of placing the analysis zone of Drese et al. within the U-shaped section of Sparks would have a reasonable expectation of facilitating fluid analysis based on properties of the fluid sample such as temperature or pH due to its proximity to the sample.
Claims 18-20 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Drese et al. (US 2010/0136699) as applied to claim 1 above, and further in view of Miller et al. (US 2004/0132166A1).
Modifying the analysis device of Drese et al. to test a sample for its acidity, or pH, was known in the art before the effective filing date of the instant application (see [0006]). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the porous membrane (medium) with the pH indicator (pH detector medium) from Miller for the benefit of absorbing a target gas for measuring the pH, and therefore the concentration, of the compound within the gas. Further, the modification of the detector of Drese et al. to include the pH porous membrane of Miller to arrive at the invention of a detector including a pH detector medium would have a reasonable expectation of successfully facilitating a reaction that would notify a user or computer of a change in pH due to a gas product.
Regarding claim 18, Drese et al. teaches a detection portion of a microchannel (analysis zone), but does not teach that there is a pH sensor arranged in the detection portion.
However, in the analogous art of chemical microfluidic chips, Miller et al. teaches a pH sensor arranged in the detection portion of the microfluidic channel, wherein the pH sensor is configured to measure a pH or a change in pH of the detector (pH sensor at reaction site 411 (detection portion) used to detect pH, see [0109] and [0181]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the pH sensor of Miller et al. for the benefit of enabling the detection of a color change of a target product at a reaction location (see [0114] in Miller et al.). The modification of the collection tank of Drese et al. to include the pH sensor of Miller et al. would have had the reasonable expectation of successfully facilitating the transfer of a signal from a pH detector to user based on signal analysis.
Regarding claim 19, modified Drese et al. teaches the system of claim 18, comprising a detector (reaction zone), but does not teach that the detector comprises a porous medium. However, in the analogous art of micro-components for the analysis of liquid chemical samples, Miller teaches a reaction system (See Abstract) wherein the detector comprises a porous medium arranged in the detection portion of the microfluidic channel (referred to as the porous membrane 410 that defines a reaction site (detector) within a channel, see [0077] and [0181]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the porous membrane (medium) of Miller for the benefit of preventing the passage of certain molecules through the paper and therefore only allowing the target analyte to diffuse through the pores (see [0182] of Miller). The modification of the zone of Drese et al. to include the porous membrane of Miller would have a reasonable expectation of successfully facilitating a chemical reaction that is then interpreted by a sensor to determine the concentration of a target compound.
Regarding claim 20, the combination of Drese et al. and Miller teaches the system of claim 19, wherein Drese et al. teaches a detector (analysis zone), but does not teach that the detector comprises a pH detector medium within the porous medium. However, Miller teaches a system (reaction system) further comprising a pH detection medium contained in the porous medium (the reaction site’s membrane (porous medium) contains a gel that indicates the pH within the porous reaction site, see [0238]).
Modifying the analysis device of Drese et al. to test a sample for its acidity, or pH, was known in the art before the effective filing date of the instant application (see [0006]). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analysis zone of Drese et al. to include the porous membrane (medium) with the pH indicator (pH detector medium) from Miller for the benefit of absorbing a target gas for measuring the pH, and therefore the concentration, of the compound within the gas. Further, the modification of the detector of Drese et al. to include the pH porous membrane of Miller to arrive at the invention of a detector including a pH detector medium would have a reasonable expectation of successfully facilitating a reaction that would notify a user or computer of a change in pH due to a gas product.
Regarding claim 23, Drese et al. teaches the system of claim 1, comprising a detector (analysis zone) with a spectrometric detector, but does not teach that the system comprises an imaging subsystem configured to image or scan the detector in the detection portion of the microfluidic channel.
However, the analogous art of Miller et al. teaches an imaging subsystem configured to image or scan the detector in the detection portion of the microfluidic channel (CCD camera is used to image reaction site (detector), see [0112] and [0205]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device of Drese et al. to improve upon the spectrometric system described and include the imaging subsystem (CCD analyzer) of Miller et al. for the for the benefit of detecting a shift in color at the reaction site (see [0114] in Miller et al.). Additionally, the modification of the pre-established processor and optical detector of Drese et al. to include controller comprising the imaging subsystem of Miller et al. would have had the reasonable expectation of successfully transmitting visual results from the microfluidic device to a user.
Regarding claim 24, Drese et al. modified by Miller et al. teaches the system of claim 23, wherein the imaging subsystem comprises a camera (a camera is used to image reaction site, see [0205] in Miller at al.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.N.M./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758