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 .
Election/Restrictions
Applicant’s election without traverse of Claims 20-37 and 39 in the reply filed on 11/25/2025 is acknowledged.
Claim 38 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/05/2025.
Claims 20-37 and 39 are pending examination in this response.
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.
Claims 20, 21, 22, 28, 29, 36, 37 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pamula et. al. (US 20070243634 A1).
Regarding claim 20, Pamula teaches “A device (Para [0053] The invention provides methods, devices and systems for executing one or more droplet-based biochemical assays.); “for manipulating many hundreds or thousands of microdroplets into an array of microdroplets using EWOD or oEWOD,” (Abstract and Paras [0463] and [0476], The present invention relates to droplet-based surface modification and washing. Droplet microactuators can be made using standard microfabrication techniques commonly used to create conductive interconnect structures on microdroplet microactuators and/or using printed-circuit board (PCB) manufacturing technology. Systems are scalable and may control tens, hundreds, thousands or more parallel droplet manipulations per droplet microactuator.); “the device comprising:
a chip” (Para [0068], In this manner, the invention provides on-chip, real-time, quantitative amplification to detect and quantify a target nucleic acid in a sample.); “comprising a first region for receiving and manipulating microdroplets” (Paras [0060], [0080], [0333], and claim 2, a device or system of the invention comprising such droplet microactuator. Otherwise manipulating such droplet on a droplet microactuator. A droplet microactuator includes components for manipulating cells along with components and reagents for conducting affinity-based assays. A first substrate comprising electrodes configured for manipulating a droplet on a surface of the substrate); “a second region for comprising the array” (Para [0033] When a liquid in any form (e.g., a droplet or a continuous body, whether moving or stationary) is described as being "on", "at", or "over" an electrode, array, matrix or surface, such liquid could be either in direct contact with the electrode/array/matrix/surface, or could be in contact with one or more layers or films that are interposed between the liquid and the electrode/ array/ matrix/ surface.); “and a plurality of electrowetting pathways” Claim 2 and Paras [0178], [0375], [0377], a second substrate arranged relative to the first substrate and spaced from the surface of the first substrate by a distance sufficient to define a space between the first substrate and second substrate. The incubation zone may include an array of electrodes to facilitate transport of droplets into and out of the zone. The zone is scalable and may include electrodes for transporting and storing tens, hundreds or more droplets within the incubation zone. The droplet microactuator will include one or more arrays, paths or networks of such electrodes. A variety of electrical properties may be employed to effect droplet operations. Examples include electrowetting and electrophoresis. The basic droplet microactuator includes a substrate including a path or array of electrodes. In some embodiments, the droplet microactuator includes two parallel substrates separated by a gap and an array of electrodes on one or both substrates); “leading from the first region of the chip to the second region” (Claim 3, and Para [0377], wherein the second substrate is arranged in a substantially parallel relationship to the first substrate. The basic droplet microactuator includes a substrate including a path or array of electrodes. In some embodiments, the droplet microactuator includes two parallel substrates separated by a gap and an array of electrodes on one or both substrates.)
“a microdroplet source configured to provide microdroplets” (Paras [0022], [0021], and [0134], dispensing one or more droplets from a source droplet. Fluid is flowed from a reservoir 1002. "Droplet" means a volume of liquid on a droplet microactuator which is at least partially bounded by filler fluid. For example, a droplet may be completely surrounded by filler fluid or may be bounded by filler fluid );
“a channel” (Para [0314], Permeate passes into a permeate flow channel 1010);
“configured to provide fluid communication between the microdroplet source and the first region of the chip” (Para [0314],Serum and/or plasma may be extracted from whole blood on the droplet microactuator and/or prior to introduction into the droplet microactuator. An example of a loading structure 1000 provided for this purpose is provided in FIG. 10. In this embodiment, fluid is flowed from a reservoir 1002 through a sealing means 1004 into a loading chamber 1006 where it comes into contact with a membrane 1008. Permeate passes into a permeate flow channel 1010 through which it flows into droplet microactuator reservoir 1012, assisted by pressure source 1014 which applies pressure via channel 1016.) Therefore the first region of the chip is the droplet microactuator and the droplet microacuator reservoir is part of the droplet microactuator and the reservoir 1002 is the source droplet.
Further taught “a pump” (Paras [0386], [0405], It will be appreciated that the droplet microactuator may nevertheless be complemented or supplemented with other droplet manipulation techniques, such as electrical (e.g., electrostatic actuation, dielectrophoresis), magnetic, thermal (e.g., thermal Marangoni effects, thermocapillary), mechanical (e.g., surface acoustic waves, micropumping, peristaltic), optical (e.g., opto-electrowetting, optical tweezers), and chemical means (e.g., chemical gradients). When these techniques are employed, associated hardware may also electronically coupled to and controlled by the controller. Fluid can be pumped in to prevent evaporation of the liquid.); The recitation “configured to move the microdroplets between the microdroplet source and the first region of the chip” is capability of the pump however taught within (Para [0432], In one alternative embodiment, droplets of sample or reagent are separated by plugs of oil in a long pre-loaded glass capillary which when connected to the droplet microactuator allows droplets of sample or reagent to be captured and routed on the droplet microactuator as they are pumped out of the capillary into the input port).
Further taught “wherein the electrowetting pathways are created by a controller configured to synchronise the movement of each microdroplet in the pathways relative to the others by application of EWOD or oEWOD force.” (Paras [0376], [0385], [0377], [0417] For example, the electrodes may be electronically coupled to and controlled by a set of manual switches and/or a controller. The droplet microactuator is thus capable of effecting droplet operations, such as dispensing, splitting, transporting, merging, mixing, agitating, and the like. Droplet manipulation is, in one embodiment, accomplished using electric field mediated actuation. Electrodes will be electronically coupled to a means for controlling electrical connections to the droplet microactuator. Continuous flow components may be controlled by the controller. Various materials are also suitable for use as the dielectric component of the substrate. Examples include: vapor deposited dielectric, such as parylene C film dielectrics, The filler fluid may be selected to have particular electrical properties. For example, certain applications including electrowetting favor the use of a filler fluid that is non-conductive (e.g., silicone oil). Or the dielectric permittivity can be selected to control the coupling of electrical energy into the system from external electrodes. In certain applications a non-conductive filler fluid can be employed as an electrical insulator or dielectric in which the droplet floats just above the electrodes without physically contacting them. For example, in an electrowetting system a layer of filler fluid (e.g., silicone oil) between the droplet and electrode can be used to provide electrostatic control of the droplet. Filler fluids may be deionized to reduce conductivity.)
Regarding claim 21, Pamula teaches all of claim 20 as above in addition to “wherein the microdroplet source is a reservoir.” (Para [0056], An illustrative droplet microactuator 100 for use in amplification protocols of the invention is illustrated in FIG. 1. In this embodiment, multiple fluid ports and/or reservoirs may be provided, such as sample reservoirs 102, PCR reagent reservoirs 104, and primer set reservoirs 106. Heating areas may also be provided, such as lower temperature heating area 108 and upper temperature heating area 110. A sample visualization area 112 may also be provided, utilizing, for example, a microscope or photomultiplier tube (PMT).)
Regarding claim 22, Pamula teaches all of claim 20 as above in addition to “wherein the microdroplet source is a droplet generator.” (Para [0172] and [0434], Thus, all reagents required to incorporate a dNTP into the immobilized sample, release PPi, and react the PPi with APS to yield ATP may be included in a reservoir on the droplet microactuator as a single source reagent for each nucleotide. The input reservoir(s) serve as reservoirs for storage of bulk source material (e.g. reagents or samples) for dispensing droplets (e.g. reagent droplets or sample droplets). Thus, the input reservoir(s) may, for example, serve as sample wells or reagent wells.
Regarding claim 28, Pamula teaches all of claim 20 as above in addition to, “wherein the average spherical microdroplet diameter is 20 to 200 µm.” (Para [0365], For example, in one embodiment, the invention makes use of one to 100 magnetically responsive beads per droplet, where the beads have an average diameter of about 25 to about 100 microns. In another embodiment the invention makes use of one to 10 magnetically responsive beads per droplet, where the beads have an average diameter of about 50 to about 100 microns.).
Regarding claim 29, Pamula teaches all of claim 28 as above in addition to “wherein the average substantially spherical microdroplet diameter is 50 to 100 µm.” (Para [0365], For example, in one embodiment, the invention makes use of one to 100 magnetically responsive beads per droplet, where the beads have an average diameter of about 25 to about 100 microns. In another embodiment the invention makes use of one to 10 magnetically responsive beads per droplet, where the beads have an average diameter of about 50 to about 100 microns.).
Regarding claim 36, Pamula teaches all of claim 20 as above in addition to, “wherein the electrowetting pathways are created by a controller configured to synchronise the movement of each microdroplet in the pathways relative to the others.” (Paras [0376], [0385], [0377], [0417] For example, the electrodes may be electronically coupled to and controlled by a set of manual switches and/or a controller. The droplet microactuator is thus capable of effecting droplet operations, such as dispensing, splitting, transporting, merging, mixing, agitating, and the like. Droplet manipulation is, in one embodiment, accomplished using electric field mediated actuation. Electrodes will be electronically coupled to a means for controlling electrical connections to the droplet microactuator. [0385], Continuous flow components may be controlled by the controller. [0377], Various materials are also suitable for use as the dielectric component of the substrate. Examples include: vapor deposited dielectric, such as parylene C… film dielectrics, [0417] The filler fluid may be selected to have particular electrical properties. For example, certain applications including electrowetting favor the use of a filler fluid that is non-conductive (e.g., silicone oil). Or the dielectric permittivity can be selected to control the coupling of electrical energy into the system from external electrodes. In certain applications a non-conductive filler fluid can be employed as an electrical insulator or dielectric in which the droplet floats just above the electrodes without physically contacting them. For example, in an electrowetting system a layer of filler fluid (e.g., silicone oil) between the droplet and electrode can be used to provide electrostatic control of the droplet. Filler fluids may be deionized to reduce conductivity.)
Regarding claim 37, Pamula teaches all of claim 28 as above in addition to, “wherein at least a proportion of the microdroplets comprise a biological or chemical material selected from: a biological cell, cell media, a chemical compound or composition, a drug, an enzyme, a bead with material optionally bound to its surface or a microsphere.” (Paras [0066] and [0134], The system of the invention may be configured and programmed to permit processing of a biological sample to prepare a droplet including a nucleic acid template for amplification. For example, cells in a droplet, whether suspended or bound to a surface, can be lysed.)
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 nonobviousness.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Pamula et. al. (US 20070243634 A1) as applied to claim 20.
Regarding claim 30, Pamula teaches all of claim 20 as above but does not explicitly teach “wherein centre to centre spacing between the electrowetting pathways is at least 100 µm.” The specification does not indicate that the distances are critical. Without some showing of unexpected results, or statement of criticality, it would have been obvious to one of ordinary skill in the art to determine, through routine experimentation, an optimum spacing between the electrowetting pathways.
Claims 23 are rejected under 35 U.S.C. 103 as being unpatentable over Pamula et. al. (US 20070243634 A1) as applied to claim 22, and in further view of Link et. al. (US 20180355350 A1).
Regarding claim 23, Pamula teaches all of claim 22 however does not teach “wherein the droplet generator is a step emulsifier.”.
Link teaches “wherein the droplet generator is a step emulsifier.” (Para [0237], The combined mixture will each (C) be separately emulsified off-line using a flow-focusing microfluidics emulsifier to synthesize individual droplets containing both a specific compound and a unique set of q-dots. As shown in FIG. 4 (Right panel), the set of individually-emulsified encoded compounds will be (D) pooled together and injected, along with either cells or enzymes, into the RDT instrument and (E) the two droplets combined to fonn individual NanoReactors.).
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 Pamula to incorporate the teachings of Link wherein the droplet generator is a step emulsifier. Doing so allows the droplet to form from a low-pressure situation which decreases the chances of the droplet breaking apart which is critical in devices which are used with droplets containing biological or sensitive chemical materials.
Claims 24, 25, 27, 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Pamula et. al. (US 20070243634 A1) as applied to claims 20 and 22 and in further view of Dunning et. al. (WO 2019219905 A1).
Regarding claim 24, Pamula teaches all of claim 20 as above but does not teach “wherein the electrowetting pathways are created by one or more moving sprite patterns.”
Dunning teaches “wherein the electrowetting pathways are created by one or
more moving sprite patterns.” (Pages 1 lines 14-16 and 8 lines 22-32, The OEWOD configuration…. For these microdroplets, the performance advantage of having the total non-conducting stack above the photoactive layer is extremely useful as the droplet dimensions start to approach the thickness of the dielectric stack and hence the field gradient across the droplet (a requirement for electrowetting-induced motion) is reduced for the thicker dielectric. This gives rise to localised directional capillary forces in the vicinity of the microelectrodes which can be used to steer the droplet along one or more predetermined pathways.).
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 Pamula to incorporate the teachings of Dunning wherein the electrowetting pathways are created by one or more moving sprite patterns. Doing so allows for increased flexibility within the device and decreases the cost to make the device by eliminating the need for features that have a higher cost.
Regarding claim 25, modified Pamula teaches all of claim 24 as above but Pamula does not teach “wherein each individual sprite controls a single microdroplet.”.
Dunning teaches “wherein each individual sprite controls a single microdroplet.” (Page 1 lines 14-16 and Page 1 lines 27 and 28, This gives rise to localised directional capillary forces in the vicinity of the microelectrodes which can be used to steer the droplet along one or more predetermined pathways. Optoelectrowetting electrode locations).
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 Pamula to incorporate the teachings of Dunning wherein each individual sprite controls a single microdroplet. Doing so allows for one device to be capable of allowing a series of reactions to take place with one droplet as one droplet is moved at a time it can then be split or moved and mixed with another to form a bigger droplet.
Regarding claim 27, Pamula teaches all of claim 20 as above but Pamula does not teach “wherein spacing between the electrowetting pathways is 2 to 4 times the average microdroplet diameter.”
Dunning teaches a deep space increases speed due to decreased surface interactions within (Pages 3 lines 6-10, page 4 lines 14-16, This ability to manipulate the morphology of the microdroplets within a device has a number of advantages. For example, where the microfluidic space is deep relative to the diameters of the microdroplets in their natural, spherical shape, the microdroplets move relatively fast because their surface interaction with each electrode location is at a minimum. In another, tapering is such as to create a microfluidic space wherein the distance between the two containing walls narrows downwards to or upwards from a maximum dimension of 150% of the microdroplets' diameters in an uncompressed state.). However, Pamula nor Dunning not explicitly teach “wherein spacing between the electrowetting pathways is 2 to 4 times the average microdroplet diameter.” The specification does not indicate that the distances are critical. Without some showing of unexpected results, or statement of criticality, it would have been obvious to one of ordinary skill in the art to determine, through routine experimentation, an optimum spacing between the electrowetting pathways in order to increase speed and have the desired speed of the droplet for the type of reaction or manipulation to take place.
Regarding claim 31, Pamula teaches all of claim 20 as above but Pamula does not teach “wherein the number of electrowetting pathways present is 2 to 250.”.
Dunning teaches “wherein the number of electrowetting pathways present is 2 to 250.” (page 1 lines 14-16, This gives rise to localised directional capillary forces in the vicinity of the microelectrodes which can be used to steer the droplet along one or more predetermined pathways.). Therefore, the one or more pathways teaches to at least two electrowetting pathways.
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 Pamula to incorporate the teachings of Dunning wherein the number of electrowetting pathways present is 2 to 250. Doing so allows for increased droplet manipulation, the more pathways the more droplet manipulation can take place. Increasing the number of pathways allows one device to manipulation more droplets at a time.
Regarding claim 32, modified Pamula teaches all of claim 31 as above but does not explicitly teach “wherein the number of electrowetting pathways present is 50 to 180.”. However, it 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 Pamula by having 50 to 180 electrowetting pathways present, since Dunning teaches multiple pathways within (page 10 lines 1-4, optoelectrowetting electrode locations may be arranged to generate multiple pathways which intersect with each other so that the translocating microdroplets can be caused to merge with secondary microdroplets at one or more points of intersection in the tapered microfluidic space.). In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the apparatus. It has been held that a mere duplication of working parts of a device involves only routine skill in the art, MPEP 2144.04 (VI)(B). One would have been motivated to duplicate the electrowetting pathways in order to allow more droplets to be processed.
Regarding claim 33, Pamula teaches all of claim 22 as above but Pamula does not teach “wherein the two or more electrowetting pathways propagate from the first region at differing angles.”.
Dunning teaches “wherein the two or more electrowetting pathways propagate from the first region at differing angles.”. (Page 10 lines 1-6, In another embodiment, the optoelectrowetting electrode locations may be arranged to generate multiple pathways which intersect with each other so that the translocating microdroplets can be caused to merge with secondary microdroplets at one or more points of intersection in the tapered microfluidic space. In this embodiment, the secondary microdroplets may be delivered by one or more secondary pathways running at an angle or even perpendicular to the principal pathways carrying the translocating microdroplets.)
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 Pamula to incorporate the teachings of Dunning wherein the two or more electrowetting pathways propagate from the first region at differing angles. Doing so allows for increased splitting as a droplet moves throughout the device allowing for one droplet to be processed in different pathways.
Regarding claim 34, Pamula teaches all of claim 22 as above but Pamula does not teach “wherein two or more electrowetting pathways propagate from the first region at substantially the same angle.”
Dunning teaches “wherein two or more electrowetting pathways propagate from the first region at substantially the same angle.” (page 10 lines 1-6, In another embodiment, the optoelectrowetting electrode locations may be arranged to generate multiple pathways which intersect with each other so that the translocating microdroplets can be caused to merge with secondary microdroplets at one or more points of intersection in the tapered microfluidic space. In this embodiment, the secondary microdroplets may be delivered by one or more secondary pathways running at an angle or even perpendicular to the principal pathways carrying the translocating microdroplets.)
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 Pamula to incorporate the teachings of Dunning wherein two or more electrowetting pathways propagate from the first region at substantially the same angle. Doing so allows for increased flexibility within the device and give stability of the droplet traveling through the device.
Claims 26 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Pamula et. al. (US 20070243634 A1) as applied to claim 20 and in further view of Wang et. al. (US 20110220505 A1).
Regarding claim 26, Pamula teaches all of claim 20 as above but does not teach “wherein the velocity of microdroplets in the electrowetting pathways is 25 to 5000 µm/s.”
Wang teaches that the velocity of the microdroplets are dependent on the voltage range and the speeds can be up to 200,000 micrometers/second within (Para [0055], The velocity of the droplet can be controlled by adjusting the control voltage in a range from 0-90 V, and droplets can be moved at speeds of up to 20 cm/s. Droplets 151 and 152 can also be transported, in user-defined patterns and under clocked-voltage control, over a 2-D array of electrodes without the need for micropumps and microvalves.)
Pamula nor Wang explicitly teach “velocity of microdroplets in the electrowetting pathways is 25 to 5000 µm/s.” However, it 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 Pamula with the invention of Wang to have the recited claim limitation, since Wang teaches that the velocity is dependent on the voltage which a set voltage is not claimed in addition Wang teaches the velocity can be up to 200,000 micrometers/second which incorporates 25 to 5000 µm/s. Having such velocity would increase the control of the movement of the droplet within the device.
Regarding claim 35, Pamula teaches all of claim 20 as above but does not teach “wherein one or more electrowetting pathways splits to form two or more electrowetting pathways.”
Wang teaches “wherein one or more electrowetting pathways splits to form two or more electrowetting pathways.” (Claim 7, Further comprising splitting the droplet by using three configured-electrodes, wherein the droplet loaded on the first configured-electrode at the center generally overlaps with the two second adjacent configured-electrodes.).
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 Pamula to incorporate the teachings of Wang wherein one or more electrowetting pathways splits to form two or more electrowetting pathways. Doing so allows for a droplet to be split as it travels throughout the pathway that splits. This increases the types of reactions the droplet may have as it is split and then travels on its own path.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Pamula et. al. (US 20070243634 A1) in view of Dunning Et. al. (WO 2019/219905 A1).
Regarding claim 39, Pamula teaches “A device” (Para [0053] The invention provides methods, devices and systems for executing one or more droplet-based biochemical assays.); “for manipulating many hundreds or thousands of microdroplets into an array using EWOD or oEWOD,” (Abstract and Paras [0463] and [0476], The present invention relates to droplet-based surface modification and washing. Droplet microactuators can be made using standard microfabrication techniques commonly used to create conductive interconnect structures on microdroplet microactuators and/or using printed-circuit board (PCB) manufacturing technology. Systems are scalable and may control tens, hundreds, thousands or more parallel droplet manipulations per droplet microactuator.); “the device comprising: a chip” (Para [0068], In this manner, the invention provides on-chip, real-time, quantitative amplification to detect and quantify a target nucleic acid in a sample.); “comprising a first region for receiving and manipulating microdroplets;” (Paras [0060], [0080], [0333], and claim 2, a device or system of the invention comprising such droplet microactuator. Otherwise manipulating such droplet on a droplet microactuator. A droplet microactuator includes components for manipulating cells along with components and reagents for conducting affinity-based assays. A first substrate comprising electrodes configured for manipulating a droplet on a surface of the substrate); “a second region comprising the array” (Para [0033] When a liquid in any form (e.g., a droplet or a continuous body, whether moving or stationary) is described as being "on", "at", or "over" an electrode, array, matrix or surface, such liquid could be either in direct contact with the electrode/array/matrix/surface, or could be in contact with one or more layers or films that are interposed between the liquid and the electrode/ array/ matrix/ surface.); “and a plurality of electrowetting pathways” Claim 2 and Paras [0178], [0375], [0377], a second substrate arranged relative to the first substrate and spaced from the surface of the first substrate by a distance sufficient to define a space between the first substrate and second substrate. The incubation zone may include an array of electrodes to facilitate transport of droplets into and out of the zone. The zone is scalable and may include electrodes for transporting and storing tens, hundreds or more droplets within the incubation zone. The droplet microactuator will include one or more arrays, paths or networks of such electrodes. A variety of electrical properties may be employed to effect droplet operations. Examples include electrowetting and electrophoresis. The basic droplet microactuator includes a substrate including a path or array of electrodes. In some embodiments, the droplet microactuator includes two parallel substrates separated by a gap and an array of electrodes on one or both substrates); “leading to the array;” (Claim 3, and Para [0377], wherein the second substrate is arranged in a substantially parallel relationship to the first substrate. The basic droplet microactuator includes a substrate including a path or array of electrodes. In some embodiments, the droplet microactuator includes two parallel substrates separated by a gap and an array of electrodes on one or both substrates.) “a microdroplet source” (Paras [0022], [0021], and [0134], dispensing one or more droplets from a source droplet. Fluid is flowed from a reservoir 1002. "Droplet" means a volume of liquid on a droplet microactuator which is at least partially bounded by filler fluid. For example, a droplet may be completely surrounded by filler fluid or may be bounded by filler fluid );
The recitation “configured to provide microdroplets of a predetermined target diameter” is capability of the microdroplet source. Pamula discloses the positively claimed structural elements of the microdroplet source as claimed, such microdroplet source are said to be fully capable of the recited adaption in as much as recited and required herein.
Further taught “a channel” (Para [0314], Permeate passes into a permeate flow channel 1010); “configured to provide fluid communication between the microdroplet source and the first region of the chip;” (Para [0314], Serum and/or plasma may be extracted from whole blood on the droplet microactuator and/or prior to introduction into the droplet microactuator. An example of a loading structure 1000 provided for this purpose is provided in FIG. 10. In this embodiment, fluid is flowed from a reservoir 1002 through a sealing means 1004 into a loading chamber 1006 where it comes into contact with a membrane 1008. Permeate passes into a permeate flow channel 1010 through which it flows into droplet microactuator reservoir 1012, assisted by pressure source 1014 which applies pressure via channel 1016.) Therefore the first region of the chip is the droplet microactuator and the droplet microacuator reservoir is part of the droplet microactuator and the reservoir 1002 is the source droplet.
Further taught “and a pressure source” (Para [0022] and [0314], Examples of "loading" droplet operations include microdialysis loading, pressure assisted loading, robotic loading, passive loading, and pipette loading. Permeate passes into a permeate flow channel 1010 through which it flows into droplet microactuator reservoir 1012, assisted by pressure source 1014 which applies pressure via channel 1016.)
The recitation “configured to move the microdroplets between the microdroplet source and the first region of the chip;” is capability of the pressure source however taught within Para [0314] above).
Pamula does not explicitly teach “wherein the electrowetting pathways on the chip are centre to centre separated by at least double the predetermined target diameter of the microdroplets from the microdroplet source;”
Dunning teaches electrowetting pathways with same angles which teaches to a center-to-center electrowetting pathways within (page 10 lines 1-6, In another embodiment, the optoelectrowetting electrode locations may be arranged to generate multiple pathways which intersect with each other so that the translocating microdroplets can be caused to merge with secondary microdroplets at one or more points of intersection in the tapered microfluidic space. In this embodiment, the secondary microdroplets may be delivered by one or more secondary pathways running at an angle or even perpendicular to the principal pathways carrying the translocating microdroplets.).
The specification does not indicate that the distances between the electrowetting pathways are critical. Without some showing of unexpected results, or statement of criticality, it would have been obvious to one of ordinary skill in the art to determine, through routine experimentation, an optimum distance between the electrowetting pathways in relation to the diameter. In addition, the predetermined target diameter of the microdroplets is capability of the channel. Thus the claimed distance is dependent on capability within the claim limitations.
Further taught within Pamula “and wherein the controller is configured to enable synchronous movement of the microdroplets in the electrowetting pathways by application of EWOD or oEWOD force.” (Paras [0376], [0385], [0377], [0417] For example, the electrodes may be electronically coupled to and controlled by a set of manual switches and/or a controller. The droplet microactuator is thus capable of effecting droplet operations, such as dispensing, splitting, transporting, merging, mixing, agitating, and the like. Droplet manipulation is, in one embodiment, accomplished using electric field mediated actuation. Electrodes will be electronically coupled to a means for controlling electrical connections to the droplet microactuator. Continuous flow components may be controlled by the controller. Various materials are also suitable for use as the dielectric component of the substrate. Examples include: vapor deposited dielectric, such as parylene C… film dielectrics. The filler fluid may be selected to have particular electrical properties. For example, certain applications including electrowetting favor the use of a filler fluid that is non-conductive (e.g., silicone oil). Or the dielectric permittivity can be selected to control the coupling of electrical energy into the system from external electrodes. In certain applications a non-conductive filler fluid can be employed as an electrical insulator or dielectric in which the droplet floats just above the electrodes without physically contacting them. For example, in an electrowetting system a layer of filler fluid (e.g., silicone oil) between the droplet and electrode can be used to provide electrostatic control of the droplet. Filler fluids may be deionized to reduce conductivity.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798