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 .
Status of Claims
The claim set submitted on 11 AUGUST 2026 is acknowledged and considered. In the claim set, Claims 1-50 and 53, 54 are ‘Cancelled’; Claims 51, 52, 55-58, 61-64, 66-68 are ‘Currently Amended’; Claims 59, 60 and 65 (actually ‘Currently Amended’), and 69; Claims 70-78 are either ‘Withdrawn’ or ‘Withdrawn, currently amended’); and Claims 79-80 are ‘New’.
Current pending claims are Claims 51, 52, 55-69 and 79-80 and are considered on the merits below.
Regarding the 112(f) analysis, in particular the “liquid droplet driving unit” or the amended version of “drive unit”; Examiner respectfully disagree that 112(f) should not be applied.
In a 112(f) analysis; a 3-prong analysis is performed for identifying 112(f) claim limitations. The 3-prong analysis consists of :
(A) The claim limitation uses the term “means” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function.
(B) The term “means” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that.”
(C) The term “means” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
See MPEP § 2181(I).
It is well known that there is there is no fixed list of generic placeholders that always result in § 112(f) interpretation.
Examples of non-structural generic placeholders that may invoke § 112(f) in some situations include: “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for.”
There is no fixed list of words that always avoid § 112(f) interpretation.
A “unit” is a non-structural generic placeholder.
The generic placeholder is modified by functional language: configured to drive the liquid injected into the fluid channel layer
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. It is not well known or by a person skilled in the art to denote sufficient definite structure to ‘drive’.
While Applicant references other patents; each patent is examined on their own merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 JUNE 2026 was filed after the mailing date of the Non-Final Office Action on 23 APRIL 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 51, 52, 55, 56, 57,58, 59, 60, 61, 62, 63, 66, 79 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over SRINVASAN, WO 2009/086403 A3, submitted on the Information Disclosure Statement on 11 JUNE 2026.
Applicant’s invention is directed towards a micro-droplet generating system.
Regarding Claim 51, the SRINVASAN discloses a micro-droplet generating system, abstract, comprising:
a microfluidic chip, Claim 1, Figure 7A, 7B, and
a droplet drive unit connected to the microfluidic chip, Figure 7A, 7B, electrode 714 and 726a-e, page 38-39,
wherein the microfluidic chip comprises an upper electrode plate and a lower electrode plate, Figure 7A, 7B, electrode 714 and 726a-e, page 38-39,
a fluid channel layer is formed between the upper electrode plate and the lower electrode plate, Figure 7A, page 38-39, gap 23,
comprises a plurality of electrodes arranged in an array, Figure 7A, 7B, 726a-e, page 38-39, the upper electrode plate and the plurality of electrodes arranged in the array form [[forms]] a plurality of suction points, Figure 7B, page 39, and the suction points are configured to absorb the drive unit is configured to drive the liquid injected into the fluid channel layer to flow in the fluid channel layer so as to form liquid micro-droplets at positions of the suction points, Figure 7A, 7B, page 38-39, 734/744, wherein each of said suction points is[[are]] formed by an electrode that is configured to be actuated in the array, page 38-39, Figure 7A, 7B.
SRINVASAN discloses the claimed invention, but is silent in regards to wherein the upper electrode plate has a plurality of electrodes arranged in an array form.
As seen in Figure 7A and 7B , there is one electrode 714, however, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the electrode 714 in SRINVASAN so that it is in array form similarly to the lower electrode plate to create a plurality of regions to accurately and precisely create droplets, page 39.
Additional Disclosures Included are: Claim 52: wherein the micro-droplet generation system of claim 51, wherein the upper electrode plate comprises an upper plate, a conductive layer and a first hydrophobic layer which are sequentially arranged; wherein the lower plate comprises a second hydrophobic layer, a dielectric layer, [[the]] an electrode layer and a substrate which are sequentially arranged, the first hydrophobic layer and the second hydrophobic layer are oppositely arranged, the fluid channel layer is formed between the first hydrophobic layer and the second hydrophobic layer, and the electrode layer comprises the plurality of electrodes and the plurality of second electrodes arranged in the array, page 38. ; Claim 55: wherein the micro-droplet generation system of claim 52, wherein each electrode of the plurality of electrodes is hexagonal and/or square in shape, Claim 21, page 22, 31, electrodes can be hexagons.; Claim 56: wherein the micro-droplet generation system of claim [[52]] 51 wherein the plurality of electrodes arranged in the array comprises at least one of a plurality of square electrodes arranged in a first array or a plurality of hexagonal electrodes arranged in [[an]] a second array, Claim 21, page 22, 31.; Claim 57: wherein the micro-droplet generation system of claim [[56]] 51 wherein the plurality of electrodes arranged in the array comprises a plurality of hexagonal electrodes arranged in a first array and a plurality of square electrodes arranged in a second array on both sides of the plurality of hexagonal electrodes arranged in [[an]] the first array, Claim 21, page 22, 31.; Claim 58: wherein the micro-droplet generation system of claim [[56]] 51 wherein the plurality of electrodes arranged in the array comprises a plurality of regular- side electrodes arranged in a first array and a plurality of hexagonal electrodes arranged in a second array on both sides of the plurality of regular-side electrodes arranged in [[an]] the first array, Claim 21, page 22, 31.; Claim 63: wherein the micro-droplet generation system according to claim 52, wherein the drive unit is an electrode driving unit connected to the electrode layer and used for controlling opening and closing of the plurality of electrodes of the electrode layer so as to control the flow of liquid injected into the fluid channel layer and form liquid micro-droplets at the positions of the suction points, page 22, control may be effeted by controlling the voltage supplied.; Claim 79 : wherein the micro-droplet generating system of claim 51, wherein the fluid channel layer comprises a first end and a second end disposed opposite each other, a height of the first end of the fluid channel layer is less than a height of the second end of the fluid channel layer, Figure 4B, page 33.; Claim 80: wherein the micro-droplet generating system of claim 51, wherein the drive unit comprises an actuator, abstract, Claim 1.
Regarding Claim 59, SRINVASAN discloses the claimed invention, but is silent in regards to the dimensions of the electrode, in particular wherein a side length of the hexagonal electrode is 50 mm to 2 mm, and the side length of the square electrode is 50 mm to 2 mm.
SRINVASAN teaches the volume of the droplets is proportional to the features of the droplets dispensing configurations such as the droplet operations electrode size and or gap height, droplets having different volumes may be dispensed from the differently sized droplet dispensing configurations, page 34.
Since SRINVASAN the volume of the droplet is proportional to the electrode size, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the SRINVASAN so that the dimensions of the electrode have a side length of the hexagonal electrode is 50 mm to 2 mm, and the side length of the square electrode is 50 mm to 2 mm to effectively and accurately modify the volume/size of the droplet.
Regarding Claim 60, the reference SRINVASAN suggest the claimed invention and discloses wherein the electrode layer comprises a plurality of first and second square electrodes arranged in an array, page 31, but is silent in regards to a plurality of first hexagonal electrodes arranged in an array and a plurality of second hexagonal electrodes arranged in an array.
While SRINVASAN teaches different configuration of the electrodes, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the shape of the electrodes to be hexagonal as this is a matter of design choice and would have found it obvious absent evidence that this particular shape is significant and to have the hexagonal electrodes arranged in an array on both sides of the plurality of regular- side electrodes arranged in an array to moving and/or splitting droplets in a desired number of directions and on both sides of the regular- side electrodes creating twice as many droplets and mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claim 61, the reference SRINVASAN discloses the claimed invention and discloses wherein the electrode layer comprises a plurality of electrodes arranged in the array comprises an electrode configuration arranged to from a square or rectangle, Claim 21, page 22 and 31, but is silent in regards to wherein the plurality of electrodes arranged in the array comprises a plurality of first hexagonal electrodes arranged in a first array, a plurality of second hexagonal electrodes arranged in a second array, and a plurality of square electrodes arranged in a third array, which are sequentially connected.
While SRINVASAN suggest different shapes of the electrode configuration, a hexagonal shape is not taught, however, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the shape of the array of the electrodes to be hexagonal as this is a matter of design choice and would have found it obvious absent evidence that this particular shape is significant and to have the hexagonal electrodes arranged in an array on both sides of the plurality of regular- side electrodes arranged in an array to moving and/or splitting droplets in a desired number of directions and on both sides of the regular- side electrodes creating twice as many droplets and mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
SRINVASAN also teaches each of the electrodes can be provided in any configuration or include any structure or shape which causes the teaches the length of the droplet extension to depend on the characteristics of the terminal electrode, such as the voltage applied to the terminal electrode, page 23.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the array of electrodes so that the plurality of first hexagonal electrodes arranged in a first array, the plurality of second hexagonal electrodes arranged in a second array, and the plurality of square electrodes arranged in a third array, which are sequentially connected to control the field gradient produced across the electrode as well as the volume of the droplets, page 23, an obvious matter of design choice and does not modify the operation of the device, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 62, the reference SRINVASAN suggest the claimed invention, but is silent in regards to wherein the plurality of first square electrodes or a side length of the square electrodes is 50 mm - 2 mm, the side length of the plurality of second square electrodes is 1/5-1/2 of the side length of the first square electrodes, the side length of the first hexagonal electrodes is 50 mm - 2 mm, and the side length of the second hexagonal electrodes is 1/5-1/2 of the side length of the first hexagonal electrodes.
SRINVASAN teaches the electrodes can have a variety of shapes, page 22. SRINVASAN also teaches each of the electrodes can be provided in any configuration or include any structure or shape which causes the teaches the length of the droplet extension to depend on the characteristics of the terminal electrode, such as the voltage applied to the terminal electrode, page 23.
SRINVASAN teaches the volume of the droplets is proportional to the features of the droplets dispensing configurations such as the droplet operations electrode size and or gap height, droplets having different volumes may be dispensed from the differently sized droplet dispensing configurations, page 34.
Since SRINVASAN the volume of the droplet is proportional to the electrode size, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the SRINVASAN so that the plurality of first square electrodes or a side length of the square electrodes is 50 mm - 2 mm, the side length of the plurality of second square electrodes is 1/5-1/2 of the side length of the first square electrodes, the side length of the first hexagonal electrodes is 50 mm - 2 mm, and the side length of the second hexagonal electrodes is 1/5-1/2 of the side length of the first hexagonal electrodes effectively and accurately modify the volume/size of the droplet.
Regarding Claim 66, the SRINVASAN reference teaches the claimed invention directed to the micro-droplet generation system of claim 64, including a distance between the first hydrophobic layer and the second hydrophobic layer, Figure 7A, page 38-39, and the gap has a height which can be modified, Figure 4B, page 33-34, but is silent in regards to wherein each of the plurality of electrodes is hexagonal, a side length of the electrode is 50mm - 2mm and a distance between the first hydrophobic layer and the second hydrophobic layer is 5 mm -600 mm.
SRINVASAN teaches the electrodes can have a variety of shapes, page 22. SRINVASAN also teaches each of the electrodes can be provided in any configuration or include any structure or shape which causes the teaches the length of the droplet extension to depend on the characteristics of the terminal electrode, such as the voltage applied to the terminal electrode, page 23.
SRINVASAN teaches the volume of the droplets is proportional to the features of the droplets dispensing configurations such as the droplet operations electrode size and or gap height, droplets having different volumes may be dispensed from the differently sized droplet dispensing configurations, page 34.
Since SRINVASAN the volume of the droplet is proportional to the electrode size, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the SRINVASAN so that the dimensions of the electrode have a side length of the hexagonal electrode is 50 mm to 2 mm, and the side length of the square electrode is 50 mm to 2 mm and the distance between the first hydrophobic layer and the second hydrophobic layer is 5 mm -600 mm to have control over the volume of the droplets, page 33-34.
Claims 67-69 are rejected under 35 U.S.C. 103 as being unpatentable over SRINVASAN, WO 2009/086403 A3, submitted on the Information Disclosure Statement on 11 JUNE 2026, and further in view of SHABANI, Lab Chip, 2011, 11, 3401.
Regarding Claim 67, the SRINVASAN reference discloses the micro-droplet generation system of claim 52, See Rejection to Claim 52 above, including wherein the microfluidic chip is provided with a first sample injection hole and a first sample drain hole, the first sample injection hole and the first sample drain hole are arranged on a first diagonal line of the microfluidic chip, Figure 12A-C, 13, but is silent in regards to wherein the drive unit includes a first micropump and a third micropump, wherein the first micropump is connected to the first sample injection hole and is used for injecting liquid into the fluid channel layer so that the fluid channel layer is filled with the liquid, and the third micropump is connected to the first sample drain hole and is used for extracting the liquid or gas flowing out of the first sample drain hole so as to form micro-droplets at the suction points.
The SHABANI reference discloses a micro-droplet generation system, Figure 1-3, comprising: a microfluidic chip and a droplet driving unit connected to the microfluidic chip, Figure 3, wherein the microfluidic chip comprises an upper electrode plate and a lower electrode plate, Figure 1, page 3401-3402, silicon substrate and metallic tube, a fluid channel layer is formed between the upper electrode plate and the lower electrode plate, Figure 1 and 3, at least one of the upper electrode plate and the lower electrode plate forms a plurality of suction points, Figure 1 and 3,; wherein a liquid droplet driving unit is used for driving the liquid injected into the fluid channel layer to flow in the fluid channel layer so as to form liquid micro-droplets at a position of the suction points, Figure 3, wherein the liquid droplet driving unit includes a micropump, wherein the micropump is connected to a sample injection hold and is used for injecting liquid into the fluid channel layer so that the fluid channel layer is filled with the liquid, Figure 3.
It would be obvious to one having ordinary skill in the art before the effective filing date to include a micropump as the liquid droplet driving unit as taught by SHABANI to have an on-demand micropump which utilizes Laplace pressure gradient between a droplet and a liquid meniscus as a propellant source, and an alteration of the surface wettability as a valving method without using any moving parts, page 3401.
SHABANI teaches the use of a micropump, but not a third micropump, wherein the third micropump is connected to the first sample drain hole and is used for extracting the liquid or gas flowing out of the first sample drain hole so as to form micro-droplets at the suction points as this would also utilize a Laplace pressure gradient between a droplet and a liquid meniscus as a propellant source, and an alteration of the surface wettability as a valving method without using any moving parts and to have fluid flow through at a constant flow rate, page 3401, 3403, and by providing another micropump this would allow for a constant flow rate through the outlet and a mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) .
Regarding Claim 68, the combination of SRINVASAN and SHABANI suggest the claimed invention, but is silent in regards to more than one injection hole and micropump.
However, it would be obvious to one having ordinary skill in the art before the effective filing date to provide more than one sample injection hold and micropump as required by the instant claim to increase the number of samples process to generate droplet and to provide an active pumping means to create a constant flow rate through the entirety of the device creating a constant generation of droplet and so that a droplet may be surrounded by or wrapped in fluid at the suction point and a mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claim 69, combination of SRINVASAN and SHABANI suggest the claimed invention, but is silent in regards to the specific thicknesses of components of the system.
SHABANI discloses the thickness of some of the components, [0064, 0065 0067, 0094].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the thickness of the components such that the thickness of the upper plate is 0.05 mm to 1.7 mm, the thickness of the substrate is 0.05 mm to 1.7 mm, the thickness of the conductive layer is 10 nm to 500 nm, the thickness of the dielectric layer is 50 nm to 1000 nm, the thickness of the electrode layer is 10 nm to 1000 nm, the thickness of the first hydrophobic layer is 10 nm to 200 nm, and the thickness of the second hydrophobic layer is 10 nm to 200 nm so that the device can operate directly as an EWOD device for accurately manipulating a droplet, [0098].
Claims 64 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over SRINVASAN, WO 2009/086403 A3, submitted on the Information Disclosure Statement on 11 JUNE 2026, and further in view of UMAPATHI, US Publication No. 2018/0318826 A1.
Regarding Claim 64, the reference SRINVASAN teaches the claimed invention, but is silent in regards to wherein the drive unit comprises a turntable.
SRINVASAN discloses a liquid injection hole is formed in the center of the microfluidic chip; the liquid injection hole is used for injecting liquid into the fluid channel layer, the microfluidic chip is also provided with a plurality of liquid drain holes, wherein the plurality of liquid drain holes are used for discharging excess liquid from the microfluidic chip, Figure 12A-D, 13.
UMAPATHI discloses an electrowetting on dielectric actuator that causes droplets to change the contact angle between the droplet and a surface that the droplet is touching. This in turn may cause the droplet to change shape, to move, to split into smaller droplets, or to merge with another droplet, abstract, [0006]. In some cases, the EWOD actuator is configured to cause the movement to occur while the drops are above the EWOD actuator. In some cases, the apparatus includes a robot that is configured to actuate rotation of the EWOD actuator in such a way that a given surface of the EWOD actuator comprises a top surface of the EWOD actuator before the rotation and comprises the bottom surface after the rotation. In some cases, the EWOD actuator is configured to modulate voltage of each electrode in the array, respectively, in such a way that electric fields created by the electrodes cause the drops to touch and press against the actuator throughout the entire rotation, [0261], rotation would imply a turntable.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the SRINVASAN reference such that the drive unit comprises a turntable configured for driving the microfluidic chip to rotate at a rotation speed so that liquid injected into the fluid channel layer forms micro-droplets at the suction points at a desired volume.
Regarding Claim 65, the reference SRINVASAN teaches the claimed invention, but is silent in regards to wherein included in the system the rotation speed greater than 0 rpm and less than or equal to 1000 rpm.
UMAPATHI discloses an electrowetting on dielectric actuator that causes droplets to change the contact angle between the droplet and a surface that the droplet is touching. This in turn may cause the droplet to change shape, to move, to split into smaller droplets, or to merge with another droplet, abstract, [0006]. In some cases, the EWOD actuator is configured to cause the movement to occur while the drops are above the EWOD actuator. In some cases, the apparatus includes a robot that is configured to actuate rotation of the EWOD actuator in such a way that a given surface of the EWOD actuator comprises a top surface of the EWOD actuator before the rotation and comprises the bottom surface after the rotation. In some cases, the EWOD actuator is configured to modulate voltage of each electrode in the array, respectively, in such a way that electric fields created by the electrodes cause the drops to touch and press against the actuator throughout the entire rotation, [0261].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the rotation speed greater than 0 rpm and less than or equal to 1000 rpm to promote mixing , heat transfer enhancement , prevent droplet collision.
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
