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 11 December 2025. Claims 1-17 and 19-20 are pending in the application. Claim 20 is newly added. Claims 1-17 and 19-20 are being examined herein.
Status of Objections and Rejections
The interpretation of claims 1-2 under 35 U.S.C. § 112(f) is withdrawn in view of amendments.
The rejections of claims 2, 16, and 17 under 35 U.S.C. § 112(b) are withdrawn in view of amendments.
The rejections of claims 1, 2, 11, and 12 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) in view of Huang, et. al. (CN105921187 A) are maintained.
The rejections of claims 3-5 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of Juncker, et. al. (WO 2019075573 A1) are maintained.
The rejections of claims 6-8, 13, and 15-16 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of Alajoki, et. al. (US 20020179445 A1) are maintained.
The rejection of claim 9 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of Jovanovich (US 20110005932 A1) are maintained.
The rejections of claims 10 and 19 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of Wang, et. al. (US 20100240051) are maintained.
The rejection of claim 14 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of Modlin, et. al. (WO 2004059299 A1) are maintained.
The rejection of claim 17 under 35 U.S.C. § 103 in view of Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) in further view of McNeely, et. al. (WO 0188204 A1) are maintained.
Response to Arguments
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
First Applicant argues, “To the contrary, Ye discloses an elastic film that is configured to deform to cause a pressure differential. That is, external pressures are, by design, transferred through the elastic film to change the pressure within the device (to thereby drive flow within the device). Ye does not disclose or suggest any air-lock element configured so that in use the internal atmosphere of the device is sealed from the external atmosphere and so that when fluid is introduced or withdrawn from the first compartment via the inlet the air-lock element maintains an overall constant pressure within the device” (Remarks, pg. 07).
Ye in view of Huang teaches microfluidic device modified to include a fluidic control unit, wherein Huang teaches the fluidic control unit is an air micropump (Huang, par. 0013). The external actuation of the elastic film to cause a pressure differential to inject fluid is simply drawn to an intended use. With the modified pump, the air chamber "d" is a closed cavity structure within the sealed microfluidic device that operates by the deformation of an elastic film to generate positive and negative pressure within the air chamber based on the movement of fluid in compartments "b" and "c" and it's actuation (Ye, par. 0014, 0033) can come from the pump as per Huang while still maintaining the structure and function of the device of Ye wherein pressure changes allow for fluid to be drawn into the device. In the device of Ye modified by Huang, the micropump provides the pressure changes to draw in the fluid through the sample inlet while the air lock “d” accounts for the change in pressure from the air micropump.
Second Applicant argues, “Furthermore, as described in claim 3 of Ye, applying external force to the elastic film covering the air chamber discharges air from the chamber (i.e. out of the chip platform), and when the external force is fully removed the air in the air chamber returns (i.e. into the chip platform). It is further described in Claim 8 and paragraph [0019] that between the steps of discharging and filling the system with air, the sample port is filled with sample solution, the external force on the air chamber is partially released and the sample solution is pulled into the enzyme inhibition reaction chamber” (Remarks, pg. 09).
Examiner notes this argument is drawn to an intended use of the of the air chamber, specifically the elastic film, of Ye. The elastic film does not need to have an external force applied to it for it to regulate pressure, if there is another force (air micropump of Huang) to change the pressure upstream the air chamber. Therefore, the air chamber “d” of modified Ye in view of Huang the structural elements of “in fluid communication with the second compartment” (Ye, Fig. 1) and is a closed cavity structure (the internal atmosphere of the device is sealed from the external atmosphere) (Ye, par. 0014, 0033) and is more than capable of maintaining the pressure within the device.
Third Applicant argues, “Further, as noted above, the air chamber of Ye is specifically provided for effecting flow. That is, Ye relies on the air chamber transferring external pressure to the interior of the device to drive fluid injection and flow. Thus, modifying Ye to arrive at the claimed combination would have fundamentally changed the principle of operation of Ye and prevented the device of Ye from operating as intended” (Remarks, pg. 10).
As stated by Ye, the primary goal of the device is simple fluid injection for flow control (par. 0022). Pumps like the air micropump of Huang are well known in the art and provide simple fluid injection and control, and the air chamber d of Ye even when used in combination with a pump acts as a sort of pressure dampener to regulate the changing pressure within the device as fluid is pumped into the inlet as it can handle the ebb and flow of positive and negative pressure changes.
Fourth, Applicant argues, “The disclosure of Juncker is all about using sacrificial reservoirs to control the flow of sample through the system, and has nothing to do with maintaining an overall constant pressure in the system” (Remarks, pg. 11)
Examiner notes Junker teaches the structural limitation of “a first chamber and a second chamber connected via a lower channel” and “wherein the first chamber is connected to the second compartment, either directly or indirectly, via an upper channel to allow fluid communication therethrough.” In microfluidic systems fluid movement, both from gases and liquids, influences one another at all parts of the system and the capillary circuits and liquid moving through them have a predefined pressure threshold (Junker, par. 0002-0003). Therefore, the capillary circuits regulate all fluid movement through connected microfluidic systems and use internal pressure to regulate fluid flow through the system. The elastic film air chamber of modified Ye and therefore be further modified by Junker to be a capillary circuit type system because both have the goal of regulating fluid flow through the microfluidic system through the influence of pressure changes.
Fifth, Applicant argues, “There is no mention in Alajoki that the system includes an air-lock element. Indeed, the disclosure of Alajoki has nothing whatsoever to do with using an air-lock element according to the claimed invention to maintain an overall constant pressure in the system” (Remarks, pg. 12).
Examiner notes the modifications from Alajoki to modified Ye do not focus on the air-lock element of the device, but instead the orientation of the layers of the microfluidic chip with respect to the inlet and microchannels. The requirements for the air-lock element are previously met by modified Ye. The modifications in view of Alajoki correspond to the inlet(s) and microchannels. Because the system of modified Ye and Alajoki both are microfluidic devices that drive fluid flow by pressure, one of ordinary skill in the art would modify the inlet(s) and microchannels of modified Ye in view of Alajoki.
Applicant presents additions arguments for Jovanovich (Remarks, pg. 13), Wang (Remarks, pg. 13), Modlin (Remarks, pg. 14), and McNeely (Remarks, pg. 15) similar to the argument for Alajoki wherein the art does not describe an air-lock element. Examiner reiterates the modification in view of Jovanovich and Wang to not center around the air-lock element but the microchannels, a kit for the system, gas-permeable membrane, and valves respectively.
Examiner further notes that motivation to modify the reference does not need to align with the present application, but for a different purpose or to solve a different problem. See MPEP 2144 IV. Further, many elements of the device, like the air lock element, are defined by their intended use or functional limitation and the structural aspects of the claim remain broad and open to their broadest reasonable interpretation.
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, 2, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ye, et. al. (CN 103865754 A) (citations made with respect to uploaded English machine translation and original document provided in IDS dated 20 October 2022) in view of Huang, et. al. (CN105921187 A) (citations made with respect to uploaded English machine translation and uploaded original document).
With regards to Claim 1, Ye teaches a microfluidic chip that utilizes pressure for rapid and accurate biochemical analysis (par. 0010-0011). Ye teaches a layer microchip device wherein the lower layer comprises compartment "b" connected to injection port "a" (a first compartment comprising an inlet) and to a second compartment "c" (a second compartment) by a microfluidic channel (a micrometer channel connecting the first and second compartments so as to allow fluid communication between the first and second compartments) and an air chamber "d" (and an air-lock element in fluid communication with the second compartment) (Fig. 1; par. 0026). Ye teaches air chamber "d" is a closed cavity structure within the sealed microfluidic device that operates by the deformation of an elastic film to generate positive and negative pressure within the air chamber based on the movement of fluid in compartments "b" and "c" (wherein the air-lock element is configured so that in use the internal atmosphere of the device is sealed from the external atmosphere and so that when fluid is introduced or withdrawn from the first compartment via the inlet the air-lock element maintains an overall constant pressure within the device) (par. 0014, 0033).
Ye is silent to an inlet that is connectable to a fluidic control unit.
Huang teaches a microfluidic device for rapid analyte detection (par. 0010). Huang teaches the device comprises multiple layers sandwiched together with an injection port 5, injection channel 12, a first pool 6 connected to a second pool 8 by connecting channel 11, and a ventilation channel 10 and vent 4 (Fig. 1, 2; par. 0017-0018). Huang teaches the tool for achieving air pressure to move the fluid within the device can be an air micropump (par. 0013) and that can be aligned with the sampling/injection port (par. 0025) (an inlet that is connectable to a fluidic control unit). Huang teaches the driving force for liquid flow in the chip is air pressure (par. 0013).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the inlet of Ye to be connected to a pump or equivalents thereof as taught by Huang in order to have a source for the force driving fluid movement through the microfluidic device. Because both devices are microfluidic chips that use pressure to move fluids throughout the microfluidic device, modifying an inlet to have a fluidic control unit as provided by Huang, provides likewise sought functionality that would have reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 2, modified Ye in view of Huang teaches the tool for achieving air pressure to move the fluid within the device can be an air micropump (par. 0013) (wherein the fluidic control unit is a gaseous fluid control unit).
With regards to Claim 11, modified Ye teaches the microfluidic channel connecting the first "b" and second "c" compartments is straight (Fig. 1) (the micrometer channel is, independently, essentially straight).
With regards to Claim 12, modified Ye teaches the microfluidic platform can be made from (but not limited to) PDMS, PC, or PS (par. 0016) (the internal walls of the compartments and the micrometer channels and/or the floor surface of the compartments are made of a polymer selected from the list of poly(dimethyl siloxane) (PDMS);… polystyrene (PS); polycarbonate (PC)).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of Juncker, et. al. (WO 2019075573 A1) (citations made with respect to uploaded copy).
With regards to Claim 3, Modified Ye teaches an air chamber "d" that comprises a single, sealed cavity structure (Fig. 1; par. 0014, 0033) (wherein the air- lock element comprises a first chamber).
Modified Ye is silent to wherein the air- lock element comprises… a second chamber connected via a lower channel to allow fluid communication therethrough and wherein the first chamber is connected to the second compartment, either directly or indirectly, via an upper channel to allow fluid communication therethrough.
Juncker teaches a capillary microfluidic device that operates by domino capillary circuits and differing capillary pressures (par. 0007, 0014). Juncker teaches this capillary circuit can mimic microfluidic valving systems (par. 0020) and comprises a reservoir 12a (a second compartment) fluidically connected to at least a first 12b and second chamber/reservoir (unlabeled) (Fig. 1b, 1c; par. 0041) (wherein the air- lock element comprises a first chamber and a second chamber). The first and second chamber (reservoir) are connected via air conduit 22b (unlabeled in figures) (Fig. 1b, 1c; par. 0052) (a first chamber and a second chamber connected via a lower channel to allow fluid communication therethrough). The first chamber/reservoir 12b is connected to reservoir 12a through main channel 12 (Fig. 1b, 1c; par. 0048-0050) (and wherein the first chamber is connected to the second compartment, either directly or indirectly, via an upper channel to allow fluid communication therethrough). Juncker teaches this capillary circuit configuration allows for higher control of fluid movement in other parts of the microfluidic system (par. 0017-0020).
It would have been obvious for one skilled in the art before the effective filing date of the invention to substitute the air chamber of modified Ye to instead be a pressure driven, hydraulic capillary circuit of Juncker in order to have more control of fluid movement throughout the entire microfluidic device. Because both devices use pressure changes to influences movement of fluid across a larger system, substituting hydraulic capillary system as provided by Junker, provides a likewise sought functionality that would yield predictable results. MPEP 2143(I)(B).
With regards to Claim 4, modified Ye in view of Juncker teaches the second chamber/reservoir comprises an outlet 14b at the uppermost position of the chamber/reservoir (Fig. 1b, 1c; par. 0041) (the second chamber of the air- lock element comprises an outlet to allow fluid flow into and out of the second chamber).
With regards to Claim 5, modified Ye in view of Juncker teaches outlet 14b is opposite of the base (unlabeled but near 18b) of the second chamber/reservoir where lower conduit 22b is connecting the first 12b and second (unlabeled) chamber/reservoir (Fig. 1b, 1c) (the second chamber comprises a base, wherein the outlet is positioned in the device at a location further from the base of the second chamber than the lower channel).
Claims 6-8, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of Alajoki, et. al. (US 20020179445 A1).
With regards to Claim 6, modified Ye teaches all the limitation as applied to Claim 1 above.
Modified Ye is silent to wherein the first compartment comprises a base, wherein the inlet is positioned in the device at a location further from the base of the first compartment than the micrometer channel.
Alajoki teaches a microfluidic device in which pressure is used to regulate flow of liquids through the device (Abstract). The microfluidic device comprises a main injection well 110 (a first compartment) with an understood inlet, and additional wells 130, 140, and 145 (a second compartment) all connected by channel 115 and 125 (Fig. 1; par. 0062-0063). The three dimensional depiction of this device is seen in Figure 3A in which injection well is seen as 310 with an open top serving as an inlet and a base at the opposite end wherein the microchannel is located (wherein the first compartment comprises a base, wherein the inlet is positioned in the device at a location further from the base of the first compartment than the micrometer channel). Alajoki teaches this embodiment of deeper wells with an inlet on top and outlet on the bottom allows for the device to perform assays that rely on having control of flow rates (par. 0008).
It would have been obvious for one skilled in the art before the effective filing date of the invention to modify the compartment of modified Ye to include a base directly opposite an inlet as provided by Alajoki in order to have better control of flow of fluids in the device. Because both devices are microfluidic devices that rely on pressure to move fluids through the system, modifying the compartment to have a base opposite the inlet as provided by Alajoki provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 7, Modified Ye teaches all the limitation as applied to Claim 1 above. Modified Ye does teach the device can have up to 100 functional units (par. 0017), but the functional units consist of all parts - injection port, first, and second compartment, and air chamber (par. 0013).
Modified Ye is silent to a further third compartment in fluid communication with the first compartment via a micrometer channel.
Alajoki teaches in addition to main injection well 110, addition wells 130, 140, and 145 can serve as a second and third compartment (Fig. 1; par. 0062-0063) (wherein the microfluidic device comprises a further third compartment in fluid communication with the first compartment via a micrometer channel). Alajoki teaches this embodiment of multiple wells allows for the device to perform assays that rely on having control of flow rates (par. 0008), and additional wells allow for additional area for holding fluid.
It would have been obvious to one skilled in the art to modify the additional functional units of modified Ye to instead contain a third compartment as taught by Alajoki in order to have additional wells/area for additional reactions/fluid in general. Because both devices are microfluidic devices that rely on pressure to move fluids through the system, modifying the additional functional units to simply be a third compartment as provided by Alajoki provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 8, modified Ye teaches all the limitation as applied to Claim 1 above. Modified Ye does teach the device can have up to 100 functional units (par. 0017), but the functional units consist of all parts - injection port, first, and second compartment, and air chamber (par. 0013).
Modified Ye is silent to multiple further compartments, each of which are in fluid communication with the first compartment via micrometer channels.
Alajoki teaches in addition to main injection well 110, addition wells 130, 140, and 145 can serve as a second, third, and fourth compartment (Fig. 1; par. 0062-0063) (wherein the microfluidic device comprises a further third compartment in fluid communication with the first compartment via a micrometer channel). Alajoki teaches this embodiment of multiple wells allows for the device to perform assays that rely on having control of flow rates (par. 0008), and additional wells allow for additional area for holding fluid.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the additional functional units of modified Ye to instead contain multiple additional compartments as taught by Alajoki in order to have additional wells/area for additional reactions/fluid in general. Because both devices are microfluidic devices that rely on pressure to move fluids through the system, modifying the additional functional units to simply be additional compartments as provided by Alajoki provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 13, modified Ye teaches two layers, including an upper layer A (Fig. 1) (an upper layer).
Modified Ye is silent to a bottom continuous layer and a sandwich layer disposed between the bottom continuous layer and the upper layer, wherein the sandwich layer comprises at least two cut-outs extending through the plane of the sandwich layer and a micrometer channel connecting the two cut-outs, wherein the at least two cut-outs and the surface of the bottom continuous layer in contact with the sandwich layer define the first and second compartments.
Huang teaches a microfluidic device with an upper layer "1," a bottom layer "3," and a layer in the middle containing the microfluidic elements "2" (Fig. 1; par. 0017) (a bottom continuous layer; an upper layer; and a sandwich layer disposed between the bottom continuous layer and the upper layer). The use of multiple layers allows for a simplistic approach to constructing the device and is a common approach well known in the field of microfluidic construction.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the two layers of modified Ye to include a third layer as taught by Huang in order to have a simple construction method of the device. Because both devices are pressure driven, layered microfluidic device, modifying the device to include a third layer as provided by Huang, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Ye in view of Huang is still silent to wherein the sandwich layer comprises at least two cut-outs extending through the plane of the sandwich layer and a micrometer channel connecting the two cut-outs, wherein the at least two cut-outs and the surface of the bottom continuous layer in contact with the sandwich layer define the first and second compartments.
Alajoki teaches compartments 310, 315, 320, and 325 begins at a top surface 305 and extend to a bottom surface of the substrate (Fig. 3A) (wherein the sandwich layer comprises at least two cut-outs extending through the plane of the sandwich layer) (wherein the at least two cut-outs and the surface of the bottom continuous layer in contact with the sandwich layer define the first and second compartments). Alajoki additionally teaches multiple channels 330, 335, 340, 345 connection the compartments (Fig. 3A) (a micrometer channel connecting the two cut-outs). Alajoki teaches this embodiment of deeper wells with outlet to a microchannel on the bottom allows for the device to perform assays that rely on having control of flow rates (par. 0008).
It would have been obvious for one skilled in the art before the effective filing date of the invention to modify the compartment of modified Ye to include a middle layer with microfluidic features that extend the height of the layer as provided by Alajoki in order to have better control of flow of fluids in the device. Because both devices are microfluidic devices that rely on pressure to move fluids through the system, modifying the middle layer as provided by Alajoki provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 15, modified Ye in view of Huang teaches the upper layer and the bottom layer are made of the same material (par. 0011) (wherein the bottom continuous layer is comprised of the same material as the upper layer).
With regards to Claim 16, Modified Ye teaches the upper layer "A" has and an opening for the injection port "a" (Fig. 1) (wherein the upper layer… comprise an aperture extending therethrough and positioned above one of the compartments so as to define the inlet).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of Jovanovich (US 20110005932 A1).
With regards to Claim 9, modified Ye teaches all of the limitations of claim 1, as seen above.
Modified Ye is silent to the micrometer channel(s) has/have, independently, a length of from about 0.1 to about 100 mm.
Jovanovich teaches a system for biochemical reactions and analysis that comprises a microfluidic cartridge that routes liquids between chambers (Abstract). Jovanovich teaches the microfluidic channels from 5mm to 10mm and up to 20mm in length (par. 0157) (the micrometer channel(s) has/have, independently, a length of from about 0.1 to about 100 mm). It is well understood that channel length influences flow rate and pressure and resistance of liquid in channel, therefore the channel length can be altered to reach a needed length.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the channel lengths of modified Ye to be 5mm to 20mm as taught by Jovanovich in order to change and manipulate the flow rate, pressure, and resistance of liquid in a microfluidic channel and device as a whole. Because both devices use microfluidic devices that move fluids through channels between different chambers, modifying the channel length as provided by Jovanovich, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of Wang, et. al. (US 20100240051).
With regards to Claim 10, Modified Ye teaches all the limitation as applied to Claim 1 above.
Modified Ye is silent to the micrometer channel(s) have a hydraulic diameter, independently, of from about 1 to about 2000 µm.
Want teaches a device within a kit for performing multiple reactions at once (Abstract). Wang teaches a microfluidic device with a main sampling chamber with an input that branches to a multitude of reaction chambers (par. 0023-0025). Wang teaches the channels that comprise the branches range from 20 to 2000 µm in width (par. 0028) (the micrometer channel(s) have a hydraulic diameter, independently, of from about 1 to about 2000 µm). It is well understood that channel diameter influences flow rate and pressure and resistance of liquid in channel, therefore the channel length can be optimized to reach a needed diameter.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the channel widths of modified Ye to be 20 to 2000 µm as taught by Wang in order to change and manipulate the flow rate, pressure, and resistance of liquid in a microfluidic channel and device as a whole. Because both devices use microfluidic devices that move fluids through channels between different chambers, modifying the channel width as provided by Wang, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 19, With regard to Claim 19, modified Ye in view of Huang teaches all the limitations of the device according to claim 1, see above.
Modified Ye is silent to the microfluidic device being in the form of a sterile, pre-packaged kit-of-parts for single use.
Wang teaches a device within a kit for performing multiple reactions at once (Abstract). Wang teaches a microfluidic device with a main sampling chamber with an input that branches to a multitude of reaction chambers (par. 0023-0025). Wang teaches the microfluidic device can come packed in a kit with materials/reagents needed for the analysis process (par. 0038-0039, 0057). Wang further teaches the device is disposable (par. 0111) (to the microfluidic device being in the form of a… pre-packaged kit-of-parts for single use). Wang teaches the benefits of a pre-packed kit with a disposable microfluidic cartridge allows for ease of use especially for those unskilled in the field (par. 0111). While not explicitly stated, it can be understood that the pre-packed kits including the microfluidic device will be sterile due to its use in the sensitive PCR; a sterile packaging environment is well established concept in the field.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify and combine the microfluidic cartridge of modified Ye to be disposable and part of a larger package as taught by Wang in order to provide an easy to access and use device for unskilled users. Because both devices use microfluidic devices for an analysis process, modify the cartridge to be disposable and combining the cartridge as a part of a larger kid, provides likewise sought after functionality with reasonable expectation of success wherein the combination would have predictable results. MPEP 2143(I)(G) and MPEP 2143(I)(B).
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of Modlin, et. al. (WO 2004059299 A1) (citations made with respect to uploaded copy).
With regards to Claim 14, modified Ye teaches all the limitations as applied to claim 1 above.
Modified Ye is silent to the microfluidic device further comprises at least one gas permeable membrane in connection with at least one of the compartments.
Modlin teaches a microfluidic device for assays with a selective permeable membrane (Abstract). Modlin teaches the microfluidic device comprises an inlet 104a, outlet 112a, channel 103a, and a gas permeable membrane110a that lines substate 118a (Fig. 6; par. 0022) Modlin teaches selectively permeable membranes allow a concentration gradient to form which influences the flow of fluids in a microfluidic device (par. 0015) and remove bubbles (par. 0022).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the compartments of modified Ye to include a gas permeable membrane as taught by Modlin in order to create a concentration gradient as well as release excess pressure and remove bubbles. Because both devices are microfluidic devices that are influenced by the presence of gas in the system, modifying the compartments to include gas permeable membranes as provided by Modlin, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable Ye, et. al. (CN 103865754 A) and Huang, et. al. (CN105921187 A) as applied to claim 1 above, and further in view of McNeely, et. al. (WO 0188204 A1) (citations made in reference to uploaded copy).
With regards to Claim 17, modified Ye teaches all the limitations as applied to claim 1 above.
Modified Ye is silent to one or more of the second, third or other compartments comprise one or more capillary valves positioned in the compartment to allow connection between the cell culture medium in use and the external atmosphere.
McNeely teaches a system for regulating gas flow in a microfluidic device (Abstract). McNeely teaches it is common for microfluidic devices to pressure to drive the microfluidic circuit, but pressure is also builds in due to gas generation from reactions within the microfluidic device (pg. 1, line 30 - pg. 2, line 15). McNeely teaches one way to vent the excess pressure build up is through the use of capillary valves (pg. 1, line 30 - pg. 2, line 15). Specifically, McNeely teaches air displacement ducts 12 and 13 connected to chambers 10 and 11 respectively (Fig. 1, 2; pg. 3, line 27 - pg. 4, line 7) (one or more of the second, third or other compartments comprise one or more capillary valves positioned in the compartment to allow connection between the cell culture medium in use and the external atmosphere). McNeely teaches the capillary valves provide venting for excess gas build up (pg. 1, line 30 - pg. 2, line 15).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the compartments of modified Ye to include capillary valves as taught by McNeely in order to vent excess pressure. Because both devices deal with influence of fluid, specifically gas, pressure within a microfluidic device, modifying the compartments to include capillary valves as provided by McNeely, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable Ye, et. al. (CN 103865754 A), Huang, et. al. (CN105921187 A), and Alajoki, et. al. (US 20020179445 A1) as applied to claim 13 above, and further in view of Modlin, et. al. (WO 2004059299 A1) (citations made with respect to uploaded copy) and O’Connor, et. al. (US 20020185184 A1).
With regards to Claim 20, modified Ye teaches all the limitations as applied to claim 13 above. Modified Ye teaches the upper layer "A" has and an opening for the injection port "a" (Ye, Fig. 1) (wherein the upper layer… comprise an aperture extending therethrough and positioned above one of the compartments so as to define the inlet).
Modified Ye is silent to the microfluidic device further comprises at least one gas permeable membrane in connection with at least one of the compartments.
Modlin teaches a microfluidic device for assays with a selective permeable membrane (Abstract). Modlin teaches the microfluidic device comprises an inlet 104c, outlet 112c, channel 106c, and a gas permeable membrane110c that lines substate 101c (Fig. 8; par. 0022) (wherein the microfluidic device further comprises at least one gas permeable membrane in connection with at least one of the compartments). Modlin further teaches gas permeable membrane 110c is also accessible from a manifold input 226 and output 228 (Fig. 8). Modlin teaches selectively permeable membranes allow a concentration gradient to form which influences the flow of fluids in a microfluidic device (par. 0015) and remove bubbles (par. 0022).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the compartments of modified Ye to include a gas permeable membrane as taught by Modlin in order to create a concentration gradient as well as release excess pressure and remove bubbles. Because both devices are microfluidic devices that are influenced by the presence of gas in the system, modifying the compartments to include gas permeable membranes as provided by Modlin, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Ye in view of Modlin is silent to wherein the one gas permeable membrane comprise an aperture extending therethrough and positioned above one of the compartments so as to define the inlet.
O’Conner teaches microfluidic reactor for performing chemical and biological synthesis reactions (Abstract). O’Conner teaches a microfluidic device comprising at least three substrate layers (Fig. 2A, 2C; par. 0056). O’Conner teaches wherein the second substrate layer 23 comprises a first 25 and second 26 aperture in fluid communication with channel 24 and the second substrate can be a semi-permeable, specifically a gas-permeable, membrane (Fig. 2A, 2C; par. 0056). O’Conner teaches the use of a selectively-permeable membrane with an aperture to serve as an inlet allows for selective filtering of material that enters the microchannel (par. 0056).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the gas-permeable membrane of modified Ye to further include an aperture within the membrane as taught by O’Conner in order to selectively filter what material enters the microchannel. Because both systems are layered microfluidic systems where a membrane lines a microchannel, modifying the membrane to have an aperture at an inlet as provided by O’Conner, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758