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 9 February 2026. Claims 1-2,4-8 and 10-20 are currently pending in this application. Claims 3 and 9 were cancelled. Claims 18-20 have been withdrawn. Claims 1-2,4-8 and 10-17 are being examined herein.
Status of Objections and Rejections
The objection to the drawings are withdrawn in view of amendments.
The rejection of claims 2, 4-7, 16, and 17 under 35 U.S.C. § 112(b) are withdrawn in view of amendments.
The rejection of claim 9 under 35 U.S.C. § 112(b) is withdrawn in view of the cancellation of the claim.
The rejection of claims 3 and 9 under 35 U.S.C. § 102(a)(1) in view of Morachis, et. al. (US 20180163713 A1) are withdrawn in view of the cancellations of the claims.
The rejection of claims 1-2, 4-6, and 8-14 under 35 U.S.C. § 102(a)(1) in view of Morachis, et. al. (US 20180163713 A1) are withdrawn in view of the amendments.
The rejection of claim 7 under 35 U.S.C. § 103 in view of Morachis, et. al. (US 20180163713 A1) in view of Shen, et. al. "An Easy Method for Pressure Measurement in Microchannels Using Trapped Air Compression in a One-End-Sealed Capillary" is withdrawn in view of the amendments.
The rejection of claim 15 under 35 U.S.C. § 103 in view of Morachis, et. al. (US 20180163713 A1) in view of Gadini, et. al. (US 20160202153 A1) and Gilbert, et. al. (US 20120015442 A1) are withdrawn in view of the amendments.
The rejection of claims 16 and 17 under 35 U.S.C. § 103 in view of Morachis, et. al. (US 20180163713 A1) in view of Brando ("Cytofluorometric methods for assessing absolute numbers of cell subsets in blood") are withdrawn in view of the amendments.
Response to Arguments
Applicant’s arguments, see remarks pages 8-13, filed 9 February 2026, with respect to the rejections of claims 1-2, 4-6, and 8-14 under 35 U.S.C. § 102(a)(1) in view of Morachis, claim 7 under 35 U.S.C. § 103 in view of Morachis in view of Shen, claim 15 under 35 U.S.C. § 103 in view of Morachis in view of Gadini and Gilbert, and claims 16 and 17 under 35 U.S.C. § 103 in view of Morachis in view of Brando have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022).
Applicant argues Morachis no longer anticipates claim 1, specifically, "Morachis does not disclose a dampener system having an air headspace configured to trap any errant air bubbles prior to entering the microfluidic device, as required by amended Claim 1" (remarks, pg. 09, par. 03).
Applicant additionally argues that the too small to trap a plurality of errant bubbles throughout the duration of the device operation (remarks, pg. 11, par. 03).
No additional arguments made for claims 2, 4-8, and 10-17 made aside from their dependence on claim 1 and that Morachis alone or in combination with the other cited references does not teach the air headspace in the chamber with the device being configured to dampen fluid flow and trap a plurality of errant bubbles (remarks, pg. 13, par. 03-04).
Kang teaches a device to pair with a microfluidic device to deliver fluid to the microfluidic device in a bubble-free and pulse-free manner (Abstract). Kang remedies the deficiencies of Morachis as Kang teaches a larger damper device with headspace to allow for gas collection. Further detail below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 8, 10-11, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022).
Regarding claim 1, Kang teaches a device to pair with a microfluidic device to deliver fluid to the microfluidic device in a bubble-free and pulse-free manner (Abstract). Kang teaches a system comprising a reservoir for holding a sample fluid (an input reservoir for holding a… sample fluid), a peristaltic pump fluidically connecting the reservoir to a fluidic chamber (a pulsatile pump coupled to said input reservoir), a fluidic chamber (a passive dampener device), and finally a microfluidic device (a microfluidic device) (Fig. 1A; pg. 3, par. 02-03).
The fluidic chamber comprises an internal cavity with an inlet to receive the fluid sample and an outlet to discharge the fluid sample and a pinch valve to control the sample fluid delivery (Fig. 1A; pg. 3, par. 02-05) (a passive dampener device having a chamber). The internal cavity of the fluidic chamber fills with the fluid allowing gas bubble to escape the liquid portion of the fluid and a top portion of the cavity remains open in order to allow gas bubble to escape the liquid and the pinch valve to operate; this captures gas bubble before the fluid enters the microfluidic device (Fig. 1B; pg. 3, par. 03, 05) (having an air headspace configured to trap any errant air bubbles prior to entering the microfluidic device)
The fluidic chamber is located downstream the peristaltic pump and upstream the microfluidic device and fluidically connects the pump with the microfluidic device (Fig. 1B) (wherein the passive dampener device is fluidically couplable downstream from the pulsatile pump and upstream from the microfluidic device). Kang further teaches this configuration, specifically the open space at the top portion of the fluidic cavity, not only allows for bubble-free fluid delivery but also a pulse-free fluid delivery (pg. 3, par. 03) (and wherein the air headspace of the chamber is further configured to dampen pressure waves created by the pulsatile pump during sample fluid flow through the microfluidic device).
Regarding claim 2, Kang teaches the peristaltic pump pumps a sample fluid from a reservoir to the fluidic chamber wherein the sample fluid passes through the fluidic chamber before being delivered to the microfluidic device (Fig. 1A, pg. 3, par. 03) (wherein the pulsatile pump is fluidically coupled to the input reservoir, the pulsatile pump causing the sample fluid flow through the passive pressure wave dampener system). Kang specifically teaches this system arrangement for analyzing blood samples, specifically the analysis of red blood cells within the blood samples (pg. 10, par. 04) (the microfluidic device is configured to process particles/cells of interest within the sample fluid flow).
Regarding claim 4, Kang teaches the fluidic chamber is an elongated cavity, with an outlet at the lowermost point, an inlet above a spot where a volume of the sample fluid is predetermined to fill, and a pinch valve that is at a position above the inlet. As the sample fluid forms a drop at the inlet, and falls into the bottom of the cavity, the gas separates from the remaining liquid parts of the sample fluid and moves into the open space at the top of the fluid chamber's cavity (pg. 3, par. 03-05) (wherein the chamber is disposed in an orientation such that air bubbles pulled from the input reservoir, or generated, by the pump and driven toward an inlet of the microfluidic device flow up into the chamber due to gravity rather than entering the microfluidic device).
Regarding claim 5, Kang teaches the peristaltic pump fills the fluidic chamber to a predetermine volume such that the volume will sufficiently fill the microfluidic device while the pinch valve is open. When the pinch valve is open, the pressure difference prevents the sample fluid from flowing into the microfluidic device. Once sufficient fluid is filled in the fluidic chamber, the pinch valve is closed and the liquid portion of the fluid sample moves into the microfluidic device due to the air bubbles still entering the fluidic chamber. Ultimately, careful control of the pressure from the air bubbles from the fluid sample through the pinch valve manipulates the fluid sample to move into the microfluid device both bubble free and pulse free (pg. 3, par. 03-05; pg. 5, par. 02-03) (wherein the chamber is filled with the… sample fluid until the chamber reaches a steady state at which the maximum value of the fluctuating pressure in the chamber matches the maximum pressure created by the pump).
Regarding claim 8, Kang teaches when the pinch valve of the fluid chamber is oriented in a closed position, the pressure difference between the fluidic chamber and microfluidic device allows the liquid to flow from the fluidic chamber into the microfluidic device even when fluid is no longer being pumped into the fluidic chamber by the pump (pg. 3, par. 04) (wherein the chamber is disposed in an orientation such that the pressurized fluid in the chamber acts to push residual particles or cells through the microfluidic device when the sample from the input reservoir is no longer being actively pumped through the microfluidic device).
Regarding claim 10, Kang teaches the cavity of the fluidic chamber is closed and this is what allows for the stabilizing the fluid flow into the microfluidic device (pg. 3, par. 01) (wherein the passive pressure wave dampener system is a fully, or functionally, closed system).
Regarding claim 11, Kang teaches the pump, fluidic chamber, and microfluidic device are three separate devices that work together to from the larger system (Fig. 1A) (wherein the passive dampener device is external to the pump and microfluidic device).
Regarding claim 13, Kang teaches the pump used is a peristaltic pump (Fig. 1A; pg. 3, par. 03) (wherein the pump is a peristaltic pump).
Regarding claim 16, Kang teaches this system arrangement for analyzing blood samples, specifically the analysis of red blood cells within the blood samples (pg. 10, par. 04) (wherein the sample fluid is a blood cell sample).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022) as applied to claim 1 in view of Fraden, et. al. (US 20170268966 A1).
Regarding claim 7, Kang teaches the outlets of the microfluidic device are fully capable of being closed, as seen in Figure 2A(a) (wherein two or more outlets of the microfluidic device are occluded). Examiner notes the overall system set up does differ, but examiner wishes to draw attention solely to the configuration of the microfluidic device as seen in Fig. 2A(a) showing it is possible to seal the outlet of the microfluidic device. Further, while the figure does only depict one outlet sealed, the second outlet is fully capable of being sealed similarly to the first outlet.
Kang is silent to (allowing) a resulting increase in pressure within the passive pressure wave dampener system to raise the air solubility of the priming or sample fluid, thereby increasing the dissolution rate of air that had been trapped within the microfluidic device.
Fraden teaches the use and method of making a microfluidic device that is filled with a fluid (Abstract). Fraden teaches in the process of treating and filling the microfluidic chip is prone gas bubbles being present. In order to remove the gas bubble, Fraden teaches plugging all outlets and injecting a solution into the inlet increases the pressure and ultimately results in the trapped gas bubbled being dissolved into the solution to create a bubble-free device (par. 0149) (to allow a resulting increase in pressure within the passive pressure wave dampener system to raise the air solubility of the priming or sample fluid, thereby increasing the dissolution rate of air that had been trapped within the microfluidic device). Fraden teaches bubbles within a microfluidic chip interferes with chip performance (par. 0149).
It would have been obvious to one skilled in the art before the effective filing date of the invention to plug the outlet of Kang to use the bubble-removing technique of Fraden to remove bubbles from a microfluidic device in order to improve the performance of the microfluidic device. Because both teach the use of microfluidic devices, using the bubble-removing technique as taught by Fraden, provides likewise functionality that will yield predictable results. MPEP 2143(I)(C).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022) as applied to claim 1 in view of .
Regarding claim 12, Kang teaches wherein the fluidic chamber is and the peristaltic pump are connected through a connector (see arrow in provided Fig. 1A below, also see thicker line between the pump and the chamber in the same Fig. 1A). The connector has one end connected to the pump and a second end connected to the fluid chamber (wherein the passive dampener device further includes a connector having a first connection in fluidic communication with the pump, a second connection in fluidic communication with a port of the chamber).
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Kang is silent to wherein the passive dampener device further includes a connector having a third connection in fluidic communication with an inlet of the microfluidic device.
Laboa teaches a fluid flow system for treatment of cell cultures (Abstract). Laboa teaches a system comprising a pulsatile pump 40 fluidically connected to a flow system 1 with both intermediately connected to fluid damping device 60 through a T-connector 63 (Fig. 6; par. 0038) (a third connection in fluidic communication with an inlet of the microfluidic device). Laboa teaches this configuration wherein the pulsatile pump is intermediately connected to a processing system by a damping device with a T-connector removes the pulsatile pumping action to have a steady flow rate (par. 0038).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the pump and fluidic chamber connection of Kang to be a three-way connector like the T-connector as taught by Laboa in order to have a system set up to remove pulsatile pumping and have a steady flow rate. Because both systems involve a damping device intermediately connected a pulsatile pump to a secondary fluid-holding system, modify the connector of the damping device to be a three-way connector as provided by Laboa, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022) as applied to claims 5 and 2 (respectively).
Regarding claim 6, Kang teaches the limitations as applied to claim 5 (see above).
Kang is silent to wherein the priming and/or sample fluid is directed into the microfluidic device instead of into the chamber that is pressurized.
Kang teaches wherein when a non-sample fluid, like a buffer for priming, is introduced into the system, the secondary fluid can be pumped directly into the microfluidic device without first moving through the fluidic chamber. This configuration as seen in Figure 3A shows the sample being introduced to the system in the same way as seen in Figure 1A, but now a secondary fluid is added (wherein the priming… fluid is directed into the microfluidic device instead of into the chamber that is pressurized). Kang teaches the addition of a secondary, non-sample fluid has multiple benefits such as diluting the sample fluid to a desired concentration (pg. 4, par. 01), confirming the bubble-free and pulse-free delivery (pg. 9, par. 03), and serving as a reference fluid (pg. 6, par. 01).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the microfluidic device of Kang to have a secondary, non-sample fluid as taught by Kang in order to have a reference fluid, to dilute the sample fluid, or to confirm the system is operating correctly. Because both systems introduce a fluid from a reservoir to a microfluidic device, modifying the device to introduce a second fluid directly into the microfluidic device as provided by Kang, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 14, Kang teaches the limitations as applied to claim 2 (see above).
Kang is silent to the system further comprising a second input reservoir for holding a priming fluid.
Kang teaches an embodiment of the system wherein a second reservoir (in the form of a syringe) holding a non-sample fluid can be added to the system (Fig. 4A) (further comprising a second input reservoir for holding a priming fluid). Kang teaches the addition of the second reservoir holding a secondary, non-sample fluid has multiple benefits such as diluting the sample fluid to a desired concentration (pg. 4, par. 01), confirming the bubble-free and pulse-free delivery (pg. 9, par. 03), and serving as a reference fluid (pg. 6, par. 01).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the microfluidic device of Kang to have a secondary reservoir for holding a secondary, non-sample fluid as taught by Kang in order to have a reference fluid, to dilute the sample fluid, or to confirm the system is operating correctly. Because both systems introduce a fluid from a reservoir to a microfluidic device, modifying the device to introduce a second fluid from a second reservoir into the microfluidic device as provided by Kang, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022) as applied to claim 1 in view of Gadini, et. al. (US 20160202153 A1) and Gilbert, et. al. (US 20120015442 A1).
Regarding claim 15, Kang teaches the system of claim 1 comprises a microfluidic device for fluid sample analysis (see claim 1 above). Kang teaches the microfluidic device comprises at least one inlet and two outlets (pg. 5, par. 05, see "Materials and Methods: A. Fabrication of the proposed fluidic chamber and microfluidic device" section) (wherein the microfluidic device comprises: and inlet; two or more outlets). Kang teaches two conjoining flow paths linearly leading from the inlets to the outlets (the specific configuration of the microfluidic device can best be seen in Fig. 2A - examiner notes the overall system set up does differ, but examiner wishes to draw attention solely to the configuration of the microfluidic device as seen in Fig. 2A(c)) (one or more flow paths extending longitudinally from the inlet toward one of the two or more outlets).
Kang is silent to each flow path containing a central channel extending to a central channel output and a plurality of micro-features adjacent to each central channel, the plurality of micro-features defining a plurality of gaps, the plurality of micro-features separating the central channel from at least one side channel, the plurality of gaps configured to fluidically couple the central channel to the at least one side channel, the at least one side channel extending along each central channel to at least one side channel output.
Gadini teaches a microfluidic device for separating sub-populations of particles in biological fluid samples (par. 0004). Gadini teaches a portion of the microfluidic device as seen in Figure 3 that separates particles from a biological sample, the microfluidic device comprising a first microfluidic channel 3 connected to an inlet 4 and the first microfluidic channel 3 leads to first outlet 5 and further branches to lead to second outlet 7; the first microfluidic channel 3 extending longitudinally from inlet 4 to outlet 5 and central to channel 8 and 9 (Fig. 3; par. 0123, 0130) (one or more flow paths extending longitudinally from the inlet toward one of the two or more outlets). As seen in Figure 3, first microfluidic channel 3 extends the length of the pathway to outlet 5, but also contains several branched paths 9 that lead to second outlet 7 (each flow path containing a central channel extending to a central channel output). Gadini teaches branched paths 9 comprise lateral delimitations 11 made from obstacles 13 immediately adjacent to first microfluidic channel (Fig. 3A; par. 0164) (a plurality of micro-features adjacent to each central channel). Between obstacles 13 are passageways 11a varying in dimension; passageways 11a connect first microfluidic path 3 to path 9 that connects to second outlet 7 (Fig. 3, 3A) (the plurality of micro- features defining a plurality of gaps, the plurality of micro-features separating the central channel from at least one side channel, the plurality of gaps configured to fluidically couple the central channel to the at least one side channel, the at least one side channel extending along each central channel to at least one side channel output). Gadini teaches efficiently separating parts of the samples is useful for diagnosing and understanding disease (par. 0005) from small sample volumes with a device that is simple to produce and practical to use (par. 0011-0013).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the microfluidic device of Kang to have the configuration and components of the microfluidic device of Gadini in order to efficiently sort small sample volumes for diagnostic use with a simple to use and produce device. Because both devices utilize a microfluidic device to sort parts of a sample, modifying the device to include a specific configuration and components within the device as provided by Gadini, provides likewise sought functionality that would have reasonable expectation of success. MPEP 2143(I)(G).
Modified Kang is still silent to wherein the passive dampener device dampens the pressure waves such that an intended portion of the sample to be sorted in each central channel is maintained within each central channel along the entirety of the one or more flow paths.
Gilbert teaches a microfluidic system that uses bubble valves under sufficient pressure to regulate fluid flow (Abstract). Gilbert teaches a particle sorter microfluidic device 160 comprising a measurement duct 166 that eventually branches at 171 into two separate branched channels 172a, 172b (Fig. 17-17C; par. 0073). Within duct 166 before branch point 171 are bubble valve with reservoirs 70 and 106, that when fluid is introduced to duct 166 a pressure variation exists between the bubble valve (Fig. 16-17C; par. 0074). The pressure difference causes liquid to discharge from 174a and change the course of direction of the selected particle 178b (Fig. 17A-17C; par. 0075-0077). This pressure difference between two reservoirs filled with gas influences the direction a selected particle moves at a branch point (pressure waves such that an intended portion of the sample to be sorted in each central channel is maintained within each central channel). Gilbert teaches the use of pressure within the bubble valve allows for regulation of fluid (and particles within the fluid) to be controlled even on a small scale without the need for complex circuitry thus having more control over the fluid flow, for example in cases where the flow can move between different channels (par. 0007, 0010).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the use the pressure regulation from the damper within the central channel of modified Kang to have further separation control in a central channel using pressure changes as taught by Gilbert in order to control the fluid path select particles take. Because both devices use the control of pressure (both through regulating it and changing it) to influences movement of particles within a branching microfluidic chamber as provided by Gilbert, provides likewise sought functionality that would have reasonable expectation of success. MPEP 2143(I)(G).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, et. al. ("Bubble-free and pulse free fluid delivery into microfluidic devices;" citations made with respect to copy provided with IDS dated 15 September 2022) as applied to claim 16 in view of Brando ("Cytofluorometric methods for assessing absolute numbers of cell subsets in blood;" citations made with respect to copy provided with OA dated 11 August 2025).
Regarding claim 17, Kang teaches the limitations as applied to claim 16 (see above).
Kang is silent to wherein the microfluidic device is configured to separate and sort the blood cell sample into a collection of red blood cells and/or platelets, a collection of lymphocyte cells, and a collection of granulocyte cells and/or monocyte cells.
Brando reviews the use of flow cytometry for quantifying types of cells in blood samples (Abstract). Brando teaches lymphocytes need to be entirely separated from monocytes and granulocytes for analysis, and even further separate the platelets and red blood cells because they are unwanted cells (pg. 329; col. 2, "Concepts Applied During Absolute Counting" section, par. 03) (wherein the microfluidic device is configured to separate and sort the blood cell sample into a collection of red blood cells and/or platelets, a collection of lymphocyte cells, and a collection of granulocyte cells and/or monocyte cells). Brando teaches the separation and quantification of cells within blood samples is a diagnostic tool for disease in humans, like for HIV (pg. 328; "Clinical Utility of Absolute CD4+ T-Cell Counting").
It would have been obvious for one skilled in the art before the effective filing date of the invention to modify the microfluidic device of the dampener system of Kang to have a microfluidic device specialized to separating blood samples into specific cell groups as taught by Brando in order to provide diagnostic results for human diseases. Because both teach of using microfluidic devices as a way to analyze blood samples, modifying microfluidic device for analyzing blood samples to specifically separate the blood sample into specific cell groups as provided by Brando, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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