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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1, 3, 4, 8, 10, 16, 17, 20, 22, 23, 40, 44, 46, 47, 49, 51, 60, 80, 81 are pending.
Claims 1, 8, 16, 20, 22, 23, 40, 49, 51, 60, 80, 81 have been amended.
Claims 2, 5-7, 9, 11-15, 18- 19, 21, 24-39, 41-43, 45, 48, 50, 52-59, 61-79, 82 are canceled.
Claim Objections
Claims 17 and 20 are objected to because of the following informalities:
Claim 17 recites “response indicative” which seems to be missing an ‘”is” and should be “response is indicative”.
Claim 20 recites “centred” which seems to be misspelled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 80, and 81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 80 recites the limitation “the isobestic point” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 81 depends on claim 80.
Claim 20 recites a use of the microfluidic device but lack positive steps on how to perform the method. Making the claims indefinite per eMPEP 2173.05(q):
Claim 20 the recites limitations “and relative peak intensity is calculated, and an average value used to calculate the pH of the pH measurement solution”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(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.
Claims 1, 8, 10, 40, 46, 51, and 16, 23 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Linder et. al. (US 2012/0269701 A1), hereinafter Linder.
Regarding Claim 1, Linder teaches: “A microfluidic device” (Para [0002], devices for performing analyses in microfluidic systems). The recitation “for measuring pH in a fluid sample” is part of the preamble and therefore has no patentable weight.
A measurement of the fluid sample is taught within (Para [0075] measured by the detector), (Para [0007], a reagent (e.g., one or more fluids such as a sample or a series of reagents); “the device comprising: a sample microfluidic channel” (Paras [0096], [0186] and Fig 7A-D, sample introduction components which can be a microfluidic channel in which the channel is on or in a substrate that at least partially directs the flow of a fluid.). The recitation “configured to transfer the fluid sample to be analysed,” is intended use of the device. Therefore, the prior art teaches to a sample microfluidic channel able to function as intended to.
Further taught “a pH indicator microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the pH indication microfluidic channel disposed on a solid substrate. The recitation “configured to transfer a pH indicator solution capable of responding to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH of the fluid sample,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed.
Further taught “a mixing microfluidic channel in fluid communication with the sample microfluidic channel and the pH indicator microfluidic channel” (Paras [0010] and [0046], reaction area having at least one meandering channel and in fluid communication with the first and/ or second microfluidic channels. The sample can pass through a reaction area within the first channel of the substrate.) The recitation “the mixing microfluidic channel being configured to mix the fluid sample to be analysed with the pH indicator solution under conditions suitable for the pH indicator solution to respond to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH,” is intended use of the channel and capability of the solution. Linder teaches all positively claimed limitations and capable of functioning as claimed.
Also taught “and an optical reading window” (Para [0043], [0168], [0042], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone.). Therefore, the meandering regions within the detection zone teaches to the optical reading window. Further taught “in fluid communication with an outlet of the mixing microfluidic channel,” (Para [0186], [0061], channel may be completely enclosed along its entire length with the exception of its inlet(s) and outlets(s). The reaction area may include one or more detection areas for detecting a component in a sample.) The reaction area, which has channels and the channels have outlets, including a detection area teaches to the optical reading window in fluid communication with the mixing channel. The recitation “through which the response indicative of the pH change can be measured optically.” Points to the capability of the optical reading window. Linder teaches the positively claimed elements and therefore is able to function as claimed.
In addition, Linder teaches (Paras [0079] and [0171], determination techniques may be used including optically-based such as absorbance and visual techniques); “wherein the sample microfluidic channel, the pH indicator microfluidic channel, and the mixing microfluidic channel are each disposed on a solid substrate;” (stated above within (Paras [0096], [0186], [0055], [0061], [0186], [0007], [0010], [0046], and Fig 7A-D).
The recitation “and wherein the mixing microfluidic channel is configured to allow diffusive mixing.” is a recitation of the capability of the mixing microfluidic channel. Linder discloses all of the positively required claimed structure elements of the claim and therefore fully capable of the recited adaption in as much as required herein.
Regarding Claim 8, Linder teaches all of claim 1. The recitation “wherein the mixing microfluidic channel is configured so that a residence time from mixing the fluid sample and the pH indicator solution to arriving at the optical reading window is longer than a minimum diffusive mixing time.” reads as a method step and not modifying the device. Therefore this recitation is interpreted as capability of the device. Linder teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method step.
Regarding Claim 10, Linder teaches all of claim 1 and further teaches “wherein the microfluidic device comprises a measuring chamber comprising the optical reading window” (Paras [0043], [0168], [0042], [0173], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone. Measuring a changing concentration.). The “and configured to receive the pH measurement solution and through which the response indicative of pH in the pH measurement solution can be measured optically.” Is a recitation of the capability measuring chamber. Linder discloses all of the positively required claimed structure elements of the claim and therefore is fully capable of the recited adaption in as much as required herein.
Regarding Claim 40, Linder teaches “A microfluidic device” (Para [0002], devices for performing analyses in microfluidic systems); “for measuring an amount of active chlorine, an amount of total chlorine and pH” (Para [0075] measured by the detector); “in a fluid sample,” (Para [0007], a reagent (e.g., one or more fluids such as a sample or a series of reagents) “;the device comprising: a sample microfluidic channel” (Paras [0096], [0186] and Fig 7A-D, sample introduction components which can be a microfluidic channel in which the channel is on or in a substrate that at least partially directs the flow of a fluid.). The recitation “configured to transfer the fluid sample to be analysed,” is intended use of the device. Therefore, the prior art teaches to sample microfluidic channel able to function as intended to. Further taught “a first reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the first reagent microfluidic channel disposed on a solid substrate. The recitation “configured to transfer a first indicator dye solution capable of reacting with any active chlorine in the fluid sample to produce an active chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of active chlorine in the fluid sample,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a second reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the second reagent microfluidic channel disposed on a solid substrate. The recitation “configured to transfer a second indicator dye solution capable of reacting with any total chlorine in the fluid sample to produce a total chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of total chlorine in the fluid sample,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a third reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the third reagent microfluidic channel disposed on a solid substrate. The recitation “ configured to transfer a pH indicator solution capable of responding to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a mixing microfluidic channel in fluid communication respectively with the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel and the third reagent microfluidic channel,” (Paras [0010] and [0061], reaction area having at least one meandering channel and in fluid communication with the first and/ or second microfluidic channels. The device may also include a sample loading area 66, such as a fluidic connector that can connect reagent storage area 64 to reaction area 68.) The recitation “which is configured to mix the fluid sample separately with the first indicator dye solution, the second indicator dye solution and the pH indicator solution under conditions suitable for some of the indicator dye in the first indicator dye solution to react with any active chlorine in the fluid sample to produce an active chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of active chlorine in the fluid sample, suitable for some of the indicator dye in the second indicator dye solution to react with any total chlorine in the fluid sample to produce a total chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of total chlorine in the fluid sample, and suitable for the pH indicator solution to respond to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH,” is intended use of the channel and capability of the solution. Linder teaches all positively claimed limitations and capable of functioning as claimed. Also taught “and an optical reading window” (Para [0043], [0168], [0042], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone.). Therefore the meandering regions within the detection zone teaches to the optical reading window. Further taught “located downstream of the mixing microfluidic channel,” (Fig 3A-3D, detection zones 162,164,166, and 168 closer to the waste area 174 than the upper portion of the reaction area 160). The recitation “through which the amount of active chlorine, the amount of total chlorine and pH in the fluid sample can be optically measured.” Points to the capability of the optical reading window. Linder teaches the positively claimed elements and therefore is able to function as claimed. In addition Linder teaches (Paras [0079] and [0171], determination techniques may be used including optically-based such as absorbance and visual techniques); “the first reagent microfluidic channel, the second reagent microfluidic channel, the third reagent microfluidic channel,” (stated above within Paras [0010] and [0046], [0096], [0186] [0055], [0061], [0186], [0007], and Fig 7A-D).
The recitation “and wherein the mixing microfluidic channel is configured to allow diffusive mixing.” is a recitation of the capability of the mixing microfluidic channel. Linder discloses all of the positively required claimed structure elements of the claim and therefore fully capable of the recited adaption in as much as required herein.
Regarding claim 46, Linder teaches all of claim 40. The recitation “wherein the flow resistance of the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, the third reagent microfluidic channel, and the mixing microfluidic channel are sufficient to minimize backflow of the fluid sample, the first indicator dye solution, the second indicator dye solution and the pH indicator solution during operation.” reads as a method step and not modifying the device. Therefore this recitation is interpreted capability of the device. Linder teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method steps.
Regarding claim 51 Linder teaches all of claim 40. The recitation “wherein the mixing microfluidic channel is configured so that a residence time from mixing the fluid sample separately with the first indicator dye solution, the second indicator dye solution and the pH indicator solution to arriving at the optical reading window is longer than a characteristic time for diffusive mixing.” reads as a method step and not modifying the device. Therefore, this recitation is interpreted as capability of the device. Linder teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method steps.
Regarding Claim 16, “A method of measuring pH in a fluid sample,” (Abstract, Fluidic connectors, methods, and devices for performing analyses); “the method comprising: providing a microfluidic device comprising: a sample microfluidic channel” (Paras [0096], [0186] and Fig 7A-D, sample introduction components which can be a microfluidic channel in which the channel is on or in a substrate that at least partially directs the flow of a fluid.).
The recitation “configured to transfer the fluid sample to be analysed,” is intended use of the sample microfluidic channel. Therefore, the prior art teaches to a sample microfluidic channel able to function as intended to.
Further taught “a pH indicator microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the pH indication microfluidic channel disposed on a solid substrate.
The recitation “configured to transfer a pH indicator solution capable of responding to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH of the fluid sample,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed.
Further taught “a mixing microfluidic channel in fluid communication with the sample microfluidic channel and the pH indicator microfluidic channel,” (Paras [0010] and [0046], reaction area having at least one meandering channel and in fluid communication with the first and/ or second microfluidic channels. The sample can pass through a reaction area within the first channel of the substrate.); “and an optical reading window” (Para [0043], [0168], [0042], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone.). Therefore the meandering regions within the detection zone teaches to the optical reading window.
Further taught “in fluid communication with an outlet of the mixing microfluidic channel,” (Para [0186], [0061], channel may be completely enclosed along its entire length with the exception of its inlet(s) and outlets(s). The reaction area may include one or more detection areas for detecting a component in a sample.) The reaction area, which has channels and the channels have outlets, including a detection area teaches to the optical reading window in fluid communication with the mixing channel.
Further taught “wherein the sample microfluidic channel, the pH indicator microfluidic channel, and the mixing microfluidic channel are each disposed on a solid substrate; (stated above within (Paras [0096], [0186], [0055], [0061], [0186], [0007], [0010], [0046], and Fig 7A-D); “mixing the fluid sample to be analysed with the pH indicator solution in the mixing microfluidic channel under diffusive mixing conditions” (Para [0088], As a positive or negative pressure differential is applied to the system, the silver salt and hydroquinone solutions eventually merge at intersection 219, where they mix slowly (e.g., due to diffusion) along channel 212).
The recitation “suitable for the pH indicator solution to respond to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH:” is capability of the of the solutions and sample within the method. Linder discloses the positively claimed structural elements of a solution and the fluid sample as claimed, such solution and fluid sample are said to be fully capable of the recited adaption in as much as recited and required herein.
Further taught “and taking an optical measurement through the optical reading window” (Para [0043], [0168], [0042], [0168], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone. FIGS. 18A and 18B illustrate an optical system 1050 at rest (FIG. 18A) and during measurement). Therefore the signal acquisition performed by a moving detector is a measurement through the optical window.
The recitation “wherein said optical measurement is indicative of the pH change” is capability of the optical measurement and dependent on the solutions and sample within the method. Linder discloses the positively claimed structural elements of a solution, fluid sample, and optical measurement as claimed, such solution, fluid sample and optical measurement are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding Claim 23, Linder teaches all of claim 16 as above. the recitation “wherein the pH to be measured is in a range between 6 and 8.5.” would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Linder by having the pH measured range within 6 to 8.5, since this pH range is slightly above and below neutral which maintains conditions for plant and animal life and also allows effective water treatment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Linder et. al. (US 2012/0269701 A1) and further view of Davis et. al. (WO 2008061315 A1).
Regarding Claim 17, Linder teaches all of claim 16 as above however does not teach “wherein the response indicative of the pH is a color change”.
Davis teaches a liquid sample is analyzed for a target chemical and a sensor such as a pH electrode may be inserted in a sample solution and the millivolts generated can be output as a pH measurement. In addition to, “wherein the response indicative of the pH is a color change” (Page 1 lines 25-28, an indicator varies in color according to the pH. The colour at a particular pH is due to the ratio of different forms of the indicator.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Davis wherein the response is indicative of the pH is a color change. Doing so creates a microfluidic device that is simple to interpret and low cost to determine results.
Regarding Claim 20, modified Linder teaches all of claim 17 as above. The recitation “wherein absorbance measurements from peaks centred at 432 nm, 560 nm, and 650 nm are measured” recites specific wavelengths which are known in the art and obvious engineering choice, when the response is for a color change as the wavelengths are specific to colors within the light spectrum for color.
Linder does not teach “and relative peak intensity is calculated, and an average value used to calculate the pH of the pH measurement solution”.
Davis teaches “and relative peak intensity is calculated, and an average value used to calculate the pH of the pH measurement solution” (Page 3 lines 28-30, The concentrations of other reagent chemicals in the cell after reagent addition can then be determined relative to the reference compound concentration.). Therefore, the reference compound is the relative peak intensity and the concentrations is the calculations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Davis wherein a relative peak intensity is calculated, and an average value used to calculate the pH of the pH measurement solution. Doing so allows the device which the method is used on to maintain stability and eliminate noise spikes which would interfere with the calculation and overall result.
Claims 22 and 49 is rejected under 35 U.S.C. 103 as being unpatentable over Linder et. al. (US 2012/0269701 A1).
Regarding claim 22, Linder teaches all of claim 16 as above. the recitation “wherein a mixing ratio of the fluid sample and the pH indicator solution is 1:1.” would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Linder by having the mixing ration 1:1, since that would have been a matter of an obvious engineering choice, to allow for consistent results and interpretation of results. Having a mixing ratio set allows for this.
Regarding claim 49, Linder teaches all of claim 40 however does not explicitly teach, “wherein the cross-section of the mixing microfluidic channel is of greater size than those of the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, the third reagent microfluidic channel”
Linder teaches (Para [0096] and [0185], channels may have consistent or variable inner diameter. all fluid channels containing embodiments of the invention are microfluidic or have a largest cross-sectional dimension of no more than 2 mm or 1 mm. In another set of embodiments, the maximum cross-sectional dimension of the channel(s) containing embodiments of the invention are less than 500 microns, less than 200 microns, less than 100 microns, less than 50 microns, or less than 25 microns. In some cases, the dimensions of the channel may be chosen such that fluid is able to freely flow through the article or substrate. The dimensions of the channel may also be chosen, for example, to allow a certain volumetric or linear flowrate of fluid in the channel. The shape of the channels can be varied by any method known to those of ordinary skill in the art.) Linder teaches that the cross-section of the channels can have varying sizes and can be selected based on needs of the device.
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to have the mixing channel cross-section be of greater size than the other channel cross-sections because Linder teaches channels with differing cross-sectional sizes and simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a mixing channel with larger cross-section size as compared to the other channels cross-sections would yield a channel that can hold a fluid sample from one or more of the channels that combine in that area which would allow for adequate fluid flow as taught in Linder (Para [0096] and [0185]).
Claim 3, 4, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Linder as applied to claim 1 above, and further in view of Clemmens et. al. (US 20090291507 A1), hereinafter Clemmens.
Regarding Claim 3 Linder teaches all of claim 1 and further teaches the meandering channel is serpentine (Para [0070], meandering channel is serpentine channel) but does not explicitly teach “wherein the mixing microfluidic channel is serpentine in form.”.
Clemmens teaches to fluidics which detect and measure analytes in liquid samples. Clemmens further teaches “wherein the mixing microfluidic channel is serpentine in form.” (Para [0150], [0133], [0176], reaction chamber used for mixing sample and reagent can comprise channels. Channels are most preferably serpentine.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Clemmens wherein the mixing channel is serpentine form. Doing so would allow for a longer path length within the microfluidic device to maximize the mixing.
Regarding Claim 4 Linder teaches all of claim 1 and further teaches the meandering channel is serpentine (Para [0070], meandering channel is serpentine channel) but does not explicitly teach “wherein the sample microfluidic channel, the pH indicator microfluidic channel and the mixing microfluidic channel are serpentine in form.”.
Clemmens teaches “wherein the sample microfluidic channel, the pH indicator microfluidic channel and the mixing microfluidic channel are serpentine in form.” Para [0150], channels are most preferably serpentine.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Clemmens wherein the channels are serpentine in form. Doing so would allow for a longer path length of each channel maximizing the area for each channel for a microfluidic device.
Regarding Claim 47 Linder teaches all of claim 40 and further teaches the meandering channel is serpentine (Para [0070], meandering channel is serpentine channel) but does not explicitly teach “, wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, and the third reagent microfluidic channel, and the mixing microfluidic channel are serpentine in form.”
Clemmens teaches “, wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, and the third reagent microfluidic channel, and the mixing microfluidic channel are serpentine in form.” (Para [0150], channels are most preferably serpentine.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Clemmens wherein the channels are serpentine in form. Doing so would allow for a longer path length of each channel maximizing the area for each channel for a microfluidic device.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Linder as
applied to claim 40 above, and further in view of Nann et. al. (US 20190039068 A1) and Eshoo et. al. (WO 2016/065300 A1), hereinafter Nann and Eshoo.
Regarding Claim 44 Linder teaches all of claim 40 and further teaches “wherein the microfluidic device is a multilayer microfluidic device” (Para [0119], cover and/ or multiple substrate layers of a device).
Linder does not teach “comprising first and second outer chips and first and second intermediate chips and wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, and the third reagent microfluidic channel are disposed on the first intermediate chip, and the mixing microfluidic channel and the optical reading window are disposed on the second intermediate chip.”
Nann teaches microfluidic device for measuring and “comprising first and second outer chips and first and second intermediate chips” (Para [0041] and [0105] FIG. 9 shows a prototype of a 4-layer-microfludic device. The microfluidic device may be a multilayer microfluidic device comprising first and second outer chips and first and second intermediate chips).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Nann wherein device comprises a first and second outer chips and first and second intermediate chips. Doing so would allow for different layers among the device in which each could be used or fabricated to function differently. In addition, having a first and second outer layer chip would protect the intermediate chips.
Nann does not teach “and wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, and the third reagent microfluidic channel are disposed on the first intermediate chip, and the mixing microfluidic channel and the optical reading window are disposed on the second intermediate chip.”.
Eshoo teaches microfluidic cartridges configured to process biological samples and teaches “and wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, and the third reagent microfluidic channel are disposed on the first intermediate chip, and the mixing microfluidic channel and the optical reading window are disposed on the second intermediate chip.” (Page 23, microfluidic cartridges comprise multiple components modules, or chambers corresponding to independent processes, tasks. Multiple components, modules, or chambers are integrated to provide a single device or two or more interconnected devices. Components and modules may include, microfluidic channels, chambers, sanitary vents, bellows chambers, bellows pumps, optical windows).
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device of Linder in view of Nann to have the fluid channels on one intermediate chip and the mixing channel along with the optical window on the other intermediate chip. Eshoo teaches microfluidic cartridges (chips) can comprise of multiple different components, chambers, channels, and optical windows. In addition, Linder teaches the mixing channel is in close proximity to the optical window. Incorporating both to have the mixing channel and the optical window on the same chip would provide for a better functioning device and having that chip in close proximity to the chip with the fluid channels comprising the sample and other fluids would once again allow for a better functioning device.
Claims 60, 80, and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Laursen et. al. (WO 2016029288 A1).
Regarding Claim 60, Linder teaches “A method of measuring an amount of active chlorine, an amount of total chlorine and pH in a fluid sample” (Abstract, Fluidic connectors, methods, and devices for performing analyses); “the method comprising: providing a microfluidic device comprising: a sample microfluidic channel” (Paras [0096], [0186] and Fig 7A-D, sample introduction components which can be a microfluidic channel in which the channel is on or in a substrate that at least partially directs the flow of a fluid.).
The recitation “configured to transfer the fluid sample to be analysed” is intended use of the sample microfluidic channel. Therefore, the prior art teaches to a sample microfluidic channel able to function as intended to.
Further taught “a first reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the first reagent microfluidic channel disposed on a solid substrate.
The recitation “configured to transfer a first indicator dye solution capable of reacting with any active chlorine in the fluid sample to produce an active chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of active chlorine in the fluid sample, is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a second reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the second reagent microfluidic channel disposed on a solid substrate.
The recitation “configured to transfer a second indicator dye solution capable of reacting with any total chlorine in the fluid sample to produce a total chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of total chlorine in the fluid sample” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a third reagent microfluidic channel” (Paras [0055], [0061], [0186], [0007, and Fig 7A-D, reagent storage area which may include one or more channels. Multiple channels which the channel is on or in the substrate and at least partially directs the flow of a fluid which is either the sample or reagent or reagents.) The reagent that is directed through the channels on a substrate teaches to the third reagent microfluidic channel disposed on a solid substrate.
The recitation “configured to transfer a pH indicator solution capable of responding to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH,” is intended use of the channel and capability of the solution. Linder teaches channels that direct flow of a fluid which are able of function as claimed. Further taught “a mixing microfluidic channel in fluid communication respectively with the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel and the third reagent microfluidic channel,” (Paras [0010] and [0061], reaction area having at least one meandering channel and in fluid communication with the first and/ or second microfluidic channels. The device may also include a sample loading area 66, such as a fluidic connector that can connect reagent storage area 64 to reaction area 68.); “and an optical reading window” (Para [0043], [0168], [0042], and Figs 18A and 18B, optical system for detecting a component in a detection zone. Device including detection zones in the form of meandering regions. Signal acquisition can be carried out by moving a detector over each detection zone.). Therefore the meandering regions within the detection zone teaches to the optical reading window. Further taught “located downstream of the mixing microfluidic channel,” (Fig 3A-3D, detection zones 162,164,166, and 168 closer to the waste area 174 than the upper portion of the reaction area 160).
Previously taught “wherein the sample microfluidic channel, the first reagent microfluidic channel, the second reagent microfluidic channel, the third reagent microfluidic channel, and the mixing microfluidic channel are each disposed on a solid substrate” (stated above within (Paras [0096], [0186], [0055], [0061], [0186], [0007], [0010], [0046], and Fig 7A-D);
Linder does not teach “mixing the fluid sample separately with the first indicator dye solution, the second indicator dye solution and the pH indicator solution under diffusive mixing conditions” but does teach diffusive mixing conditions within (Para [0088], As a positive or negative pressure differential is applied to the system, the silver salt and hydroquinone solutions eventually merge at intersection 219, where they mix slowly (e.g., due to diffusion) along channel 212).
Laursen teaches a mini-fluidics cassette, for detection of at least one analyte in a sample in addition to “mixing the fluid sample separately with the first indicator dye solution, the second indicator dye solution and the pH indicator solution under diffusive mixing conditions” (Page 4 lines 21-23, according to yet another embodiment, each of said inlet ports of said at least one sample and at least one reagent and said channel have a diameter for a controlled mixing ratio of said at least one sample to said at least one reagent.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Linder to incorporate the teachings of Laursen wherein the mixing the fluid sample separately with the first indicator dye solution, the second indicator dye solution and the pH indicator solution under diffusive mixing conditions”. Doing so decreases interferences with each indicator and pH indicator to allow optimal reactions to take place.
The recitation “suitable for some of the indicator dye in the first indicator dye solution to react with any active chlorine in the fluid sample to produce an active chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of active chlorine in the fluid sample, suitable for some of the indicator dye in the second indicator dye solution to react with any total chlorine in the fluid sample to produce a total chlorine measurement solution having a reduced indicator dye concentration that is indicative of the amount of total chlorine in the fluid sample, and suitable for the pH indicator solution to respond to pH in the fluid sample to produce a pH measurement solution having a response indicative of the pH, and measuring the amount of active chlorine, the amount of total chlorine and pH in the fluid sample through the optical reading window”. is capability of the of the solutions and mixing within the device of the method. Linder discloses the positively claimed structural elements of a solutions and mixing as claimed, such solutions and mixing are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding Claim 80, modified Linder teaches all of claim 60 as above. The recitation “wherein a detection wavelength for measuring an amount of active chlorine and/or an amount of total chlorine is set at the isosbestic point of methyl orange at 469 nm.” would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Linder by having the measuring wavelength of 469 nm, since Laursen teaches colorimetric analysis and 469 nm is a wavelength used for such analysis.
Regarding Claim 81, modified Linder teaches “wherein a measured absorbance at 650nm as background was subtracted from a measured absorbance at 469 nm, and average values are used for measuring the amount of active chlorine and the amount of total chlorine.” would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Linder by having the claimed wavelengths, since Laursen teaches colorimetric analysis and 469, 650 nm is a wavelengths used for such analysis.
Response to Amendments
Claim Amendments
Applicants’ amendments overcome the previous 112(b) rejections in the non-final office action except for claims 20 and 80. Applicants amendments have overcome the 101 rejection by adding method steps within the method claims.
Response to Arguments
Applicant's arguments filed 9/30/2025 have been fully considered but they are not persuasive.
Applicant argues that claims 1,16, 40, and 60 are novel and not obvious for at least the following reasons:
Applicant states Linder fails to disclose or suggest “measuring pH in a fluid sample”.
Examiner points out that this recitation is part of the preamble and features or steps required to measure the pH are not positively recited in the claims.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Linder is capable of performing the measurement in as much as positively claimed.
Applicant argues that Linder fails to teach “a mixing microfluidic channel disposed on a solid substrate and in fluid communication with the sample microfluidic channel and the pH indicator channel.”
Examiner disagrees and maintains that this is taught within (Paras [0010] and [0046], reaction area having at least one meandering channel and in fluid communication with the first and/ or second microfluidic channels. The sample can pass through a reaction area within the first channel of the substrate.).
Applicant argues that Linder does not allow diffusive mixing of the pH indicator reagent and the sample and argues that Linder does not mention mixing of pH indicator reagent or any fluid reagent with a sample.
Examiner disagrees and Linder teaches mixing in as much as positively claimed within the claims above in addition to teaching diffusing mixing conditions within (Para [0088], As a positive or negative pressure differential is applied to the system, the silver salt and hydroquinone solutions eventually merge at intersection 219, where they mix slowly (e.g., due to diffusion) along channel 212). In addition, the method claims that have been amended show such diffusive mixing disclosed within in Laursen above on (Page 4 lines 21-23, according to yet another embodiment, each of said inlet ports of said at least one sample and at least one reagent and said channel have a diameter for a controlled mixing ratio of said at least one sample to said at least one reagent.).
Applicant argues that one of ordinary skill in the art wanting a microfluidic device for measuring a pH in solutions would not have looked or considered Linder because Linder does not mention or suggest pH measurements and does not disclose or suggest diffusive mixing of the sample and a pH indicator reagent.
Examiner disagrees, Linder discloses all of the positively claimed limitations within the independent device claims in addition to teaching methods and devices for performing analysis with fluidic connectors within the (Abstract, Fluidic connectors, methods, and devices for performing analyses). Therefore, the pH measurement is an analysis and it would be obvious to considered Linder.
Applicant argues that Linder fails to disclose or suggest or with combination of other sited prior art measuring pH in a fluid sample, mixing microfluidic channel deposited on a solid substrate and in fluid communication with the sample microfluidic channel and the pH indicator channel and diffusive mixing. Applicant argues that the independent and dependent claims are novel and reconsideration and withdraw is requested for the rejections.
Examiner disagrees and maintains the rejections for the device and has made new rejections based on method claim amendments. Examiner has addressed each of the things the applicant is arguing Linder fails to disclose above.
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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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798