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 12 January 2026. Claims 1-20 are pending in the application. Claims 11-20 are previously withdrawn. Claims 1-10 are being examined herein.
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-10 in the reply filed on 12 January 2026 is acknowledged.
Claim 11-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 January 2026.
Status of the Objections and Rejections
The rejection of claims 4 and 8 under 35 U.S.C. § 112(b) are withdrawn in view of explanation and amendments.
The rejection of claims 1, 5, 6, and 8 under 35 U.S.C. § 102(a)(1) in view of Bort, et. al. (US 20140161686 A1) are withdrawn in view of amendments.
The rejections of 2-4, 7, and 9 under 35 U.S.C. § 103 in view of Bort, et. al. (US 20140161686 A1) in view of Ho (US 20040132218 A1) are withdrawn in view of amendments.
The rejection of claim 10 under 35 U.S.C. § 103 in view of Bort, et. al. (US 20140161686 A1) in view of Johnson (US 20200197931 A1) is withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see Remarks pages 08-10, filed 12 January 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 102(a)(1) in view of Bort, et. al. (US 20140161686 A1) 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 Therefore, the rejection has been withdrawn.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 Bort, et. al. (US 20140161686 A1) in view of Handique, et. al. (US 20140272965 A1).
Applicant argues that Bort alone does not teach a channel through which the inlet port can fill a chamber. Examiner agrees that there is not a channel to fill the chamber through the inlet as disclosed by Bort.
Applicant's arguments filed 12 January 2026 have been fully considered but they are not persuasive.
Applicant argues that adding a channel to the preloaded chamber as recited by Bort is not obvious and further “would not have provided any apparent benefit and, instead, would have come along with drawbacks” (Remarks, pg. 09, par. 02). Examiner, however, disagrees. While Bort does teach the chambers are preloaded (Bort, par. 0049-0052), the chamber must be loaded by some means regardless of whether the chambers are preloaded or loaded at the time of use. Ultimately, the chamber is not built surrounding a fluid, but a fluid is loaded into the chamber before use.
Bort offers no information regarding the preloading process of the chamber.
Handique teaches a microfluidic device with a with a fluid reservoir attached to a manifold (Handique, par. 0026). Handique teaches the fluid reservoir is filled by a fluid delivery module in a sealed system (par. 0028). Handique teaches the use of the fluid delivery module in combination with the fluid reservoir then attaching to a manifold allows for controlled introduction of the fluid into the manifold (par. 0040). More detail can be found below.
Applicant offers no additional arguments for claims 2-10 aside from their dependence on claim 1, see Remarks pg. 10, par. 02, 04, and 06.
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, 5, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bort, et. al. (US 20140161686 A1) in view of Handique, et. al. (US 20140272965 A1).
Regarding claim 1, Bort teaches a microfluidic droplet actuating system (Abstract) (a microfluidic device including a microfluidic circuit). Bort teaches a barrel 1452 that holds a quantity of liquid 1454 with an inlet (unlabeled) at an upper position of barrel 1452 covered by seal 1460 (Fig. 14; par. 0074-0075) (an inlet port; a chamber configured to receive fluid from the inlet port, the chamber containing a reagent; a first valve or frangible member). Bort teaches seal 1460 retains liquid 122 inside barrel 1452 by remaining sealed closed (par. 0075) (a closed position in which fluid is prevented from entering or exiting the chamber through the first valve or frangible member) and can be pierced by piercer 1470 to puncture and open seal 1460 (par. 0076) (an open position in which fluid is permitted to enter or exit the chamber through the first valve or frangible member).
Bort teaches barrel 1452 leads to droplet operations gap 1414 (reservoir) that collects liquid 1454 after second seal 1458 is pierced by piercing edge 1422 at loading port 1420 (Fig. 14; par. 0075, 0077-0078); Bort teaches droplet operations gap contains a filler fluid that is typically an oil (par. 0053) (a reservoir configured to receive liquid from the chamber, the reservoir containing a non-aqueous liquid). Bort teaches at the lowermost position of barrel 1452 is second seal 1458 (a second valve or frangible member having) that holds liquid in barrel 1452 until ready for use (par. 0075) (a closed position in which fluid is prevented from flowing between the chamber and the reservoir through the second valve or frangible member), and when ready for use, is pierced by piercing edge 1422 allowing liquid 1454 to move from barrel 1452 to droplet operations gap 1414 (par. 0077-0078) (an open position in which fluid is permitted to flow between the chamber and the reservoir through the second valve or frangible member).
Bort teaches bottom substrate 1410, that partially delimits droplet operations gap 1414, comprises an arrangement of droplet operations electrodes 1416 creating a droplet operations surface once seal 1458 breaks and liquid 1454 moves from barrel 1452 to droplet operations gap 1414 (Fig. 14; par. 0074) (a droplet-generating region configured to receive liquid from the reservoir and produce droplets of the liquid from the reservoir).
The difference between the droplet operations gap 1414 being read as the reservoir and the surface of substrate 1410 comprising electrodes 1416 being read as the droplet generating region can be summarized as follows: The channel itself does not generate droplets it is an open space between a top 1412 and bottom substrate 1410, channel or reservoir, to hold liquid that comes from barrel 1452 through loading port 1420 to be acted up droplet operations electrodes 1416 the portion of the bottom substrate comprising electrodes 1416 is the droplet-generating region.
Bort is silent to the fluid being received from the inlet port being done through a channel.
Handique teaches a microfluidic system comprising a fluid delivery module, a reservoir, and a manifold (Abstract). Handique teaches the system comprises a reservoir 130 configured to hold a fluid received through inlet 131 by fluid delivery module 105 and ultimately delivers fluid in a controlled fashion to microfluidic manifold 140 (Fig. 2A; par. 0027-0028). The fluid deliver module 105 comprises at least one elongated chamber (channel) that holds the fluid to be delivered to reservoir 130 (par. 0027-0029) (through a channel). Handique teaches the use of the fluid delivery module in combination with the fluid reservoir then attaching to a manifold allows for controlled introduction of the fluid into the manifold (par. 0040).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the microfluidic device of Bort to further include a channel configured to deliver fluid to a reservoir as taught by Handique in order to have more control over the fluid flow being introduced to the microfluidic system. Because both systems have reservoirs that hold a liquid to be introduced to a microfluidic manifold, modifying the system to have a channel/system to deliver fluid to the reservoir as provided by Handique, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 5, modified Bort teaches first seal 1460 is configured to retain a liquid until penetrated and comprises a material like foil or cellophane (Bort, par. 0075) (the first valve or frangible member comprises a first fluid-impermeable membrane).
Regarding claims 6, modified Bort teaches second seal 1458 is configured to retain a liquid until penetrated and comprises a material like foil or cellophane (Bort, par. 0075) (the second valve or frangible member comprises a second fluid-impermeable membrane).
Regarding claim 8, modified Bort teaches all seals 1460, 1458 are arranged such that a single axis runs perpendicularly to all three (Bort, Fig. 14) (the first fluid-impermeable membrane and the second fluid-impermeable membrane are aligned such that an axis extends through each).
Claims 2-4, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bort, et. al. (US 20140161686 A1) and Handique, et. al. (US 20140272965 A1) as applied to claim 1 above, in further view of Ho (US 20040132218 A1).
With regards to Claim 2, modified Bort teaches a third seal 1462 at the uppermost position of barrel 1452 above seal 1460 (Fig. 14; par. 0075) (the microfluidic circuit comprises a third valve or frangible member). This divides the dispenser into a portion that includes seal 1462 and the area above seal 1462, and a second portion that includes seal 1460 and is below seal 1462 (Fig. 14) (that separates the chamber into a first portion and a second portion). Bort teaches seal 1462 can be a hydrophobic and oleophobic membrane and is sealed and all liquid/reagent 1454 remains in barrel 1452 allowing air to vent through the device (par. 0075-0076, 0078) (a closed position in which gas, but not liquid, is permitted to flow between the first and second portions through the third valve or frangible member). Bort does teach that liquid/reagent 1454 is not limited to being liquid but can also be a dry reagent that is reconstituted upon puncturing of the seal and entering the droplet-generating region (par. 0038).
Bort is silent to an open position in which fluid is permitted to flow between the first and second portions through the third valve or frangible member.
Ho teaches a microfluidic device with a plurality of reagent cavities separated by breakable seals (Abstract). Ho teaches the microfluidic device comprises a four-layer structure with a buffer solution 50 stored in the reagent buffer layer 51 and dry reagent 54 stored in dry reagent cavity 55 in the dry reagent layer 52 (Fig. 4; par. 0022). The buffer solution and dry reagent are separated by a first thin film 53 (Fig. 4; par. 0022) (the microfluidic circuit comprises a third valve or frangible member that separates the chamber into a first portion and a second portion). Ho teaches an actuator that engages with a microcap assembly housing a pin that pushes downward puncturing the thin film 53 separating the buffer solution from the dry reagent (Fig. 4; par. 0022) (an open position in which fluid is permitted to flow between the first and second portions through the third valve or frangible member). Ho teaches this configuration mitigates common problems associated with microfluidic devices like air bubbles associated with deal volume (par. 0010).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the air permeable membrane in the chamber of Bort to include a pierceable seal/membrane in the middle of the chamber as taught by Ho in order to prevent air bubbles and further allow mixing of dry reagents with solution at a specified time. Because both devises use microfluidic devices with pierceable chambers with mixable reagents for analysis, modifying the membrane to be pierceable as provided by Ho, provides likewise sought functionality with reasonable expectation of success. MPEP § 2143(I)(G).
Regarding claim 3, modified Bort teaches seal 1462 can be a hydrophobic and oleophobic membrane, specifically a Versapor membrane that is air-permeable (Bort, par. 0075) (the third valve or frangible member comprises an air-permeable membrane).
Regarding claim 4, modified Bort in view of Ho teaches thin film 53 holds/encloses a buffer solution in the reagent buffer layer until pierced by a pin allowing the buffer to move down into the dry reagent layer 52 (Ho, Fig. 4; par. 0022) (the air-permeable membrane comprises the reagent).
Regarding claim 7, modified Bort teaches first seal 1460 is configured to retain a liquid until penetrated and comprises a material like foil or cellophane (Bort, par. 0075) (the first valve or frangible member comprises a first fluid-impermeable membrane). Bort teaches second seal 1458 is configured to retain a liquid until penetrated and comprises a material like foil or cellophane (Bort, par. 0075) (the second valve or frangible member comprises a second fluid-impermeable membrane). Bort teaches all three seals 1460, 1458, and 1462 are arranged such that a single axis runs perpendicularly to all three (Bort, Fig. 14) (and the first fluid-impermeable membrane, the second fluid-impermeable membrane, and the air-permeable membrane are aligned such than an axis extends through each).
Regarding claim 9, modified Bort teaches a piercer 1470 that moves along the axis perpendicular to seals 1460 and 1462 to pierce seal 1460 (Bort, Fig. 14; par. 0078) (a penetrator that is movable relative to the membranes along the axis). Modified Bort teaches upon dispenser 1450 moving downward, edge 1422 pierces seal 1458 along a perpendicular axis (Bort, Fig. 14; par. 0078).
Modified Bort is silent to a (single) penetrator configured to puncture the membranes such that the membranes are in the open position.
Ho teaches beyond the dry reagent layer 52 below dry reagent cavity 55 is a second thin film 56 that separate the above sections from the microchannel layer (Fig. 4; par. 0022). When the microcap assembly housing the pin is actuated, the pin pierces first the first thin film 53 mixing the dry reagents and buffer, and then pierces the second thin film 56 forcing the mixture into the microchannel (Fig. 4; par. 0022) (the penetrator configured to puncture the membranes such that the membranes are in the open position). It can be seen in Figure 4 that the pin moves from the upper layer to the lowermost layer. Ho teaches the full range of piercing by a singular piercing element ensures the mixing of the dry reagent with the buffer solution and moving that mixture down to the microchannel for further analysis (par. 0022).
It would have been obvious to one skilled in the art before the effective filing dating of the invention to modify two-piercer configuration of modified Bort to instead be a single piercer that penetrates all seals/membranes as taught by Ho in order to thoroughly move all reagents/mixtures from the holding cavities/chambers, into a microchannel for further analysis/processing. Because both devices deal with a piercing element penetrating seals/membranes to mix reagents and move mixtures downstream for further processing, modifying the piercing element to be a single piercing element that penetrates all seals/membranes through the full length as provided by Ho, provides likewise sought functionality with reasonable expectation of success. MPEP § 2143(I)(G).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bort, et. al. (US 20140161686 A1) and Handique, et. al. (US 20140272965 A1) as applied to claim 1 above, in view of Johnson (US 20200197931 A1).
Regarding claim 10, modified Bort teaches all the limitations as applied to claim 1 above.
Bort is silent to the droplet-generating region includes a flow path having a minimum cross-sectional area that increases along the flow path in a direction away from the reservoir.
Johnson teaches a microfluidic chip with a microfluidic network with droplet-generating regions (Abstract). Johnson teaches a microfluidic chip with ports and channels that hold an aqueous and non-aqueous liquid and uses pressure changes to move the liquids through the microfluidic network to a droplet-generating region (par. 0059-0063). Johnson teaches the droplet-generating region includes a flow path starting with a constriction section 76 leading to an expansion region 98 wherein droplets are subsequently formed and move along the flow path (Fig. 9A-D; par. 0063) (the droplet-generating region includes a flow path having a minimum cross-sectional area that increases along the flow path in a direction away from the reservoir). Johnson teaches including a downstream expansion of the channel creates consistently sized droplets and helps propels the droplets forward (par. 0009).
It would have been obvious to one skilled in the art before the effective filing date of the invention to combine the droplet generating region of Bort to include a flow path with an expanding cross-sectional area as provided by Johnson in order to form drops of the same size and encourage downstream movement of the drops. Because both inventions deal with a microfluidic device that generate droplets for analysis, combining the droplet generating region to include an expanding flow path as provided by Johnson, provides likewise sought functionality and results of the combination would yield predictable results. MPEP § 2143(I)(A).
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.
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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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