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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 18 July 2025.
Claims 1-17 are pending.
Claims 8-15 are withdrawn from consideration.
No claims are cancelled.
Claims 1-5 and 7 are amended.
Claims 16 and 17 are newly added.
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 1-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Umapathi (US 2019/0262829 A1), referred to hereinafter as “Umapathi”, in view of Kim et al. (US 2010/0096266 A1), referred to hereinafter as “Kim”.
Regarding Claim 1, Umapathi teaches an apparatus comprising:
a digital microfluidic (DMF) array 100 including a plurality of droplet manipulation electrodes 120 (Figs. 1A and 1B);
a controller communicatively coupled to a droplet dispenser to deposit fluid on the DMF array ([0231]: “Various processes described herein may be implemented by appropriately programmed general purpose computers, special purpose computers, and computing devices.” – See also Fig. 12C. [0183]: “Droplets may be dispensed onto the chip through one or more “liquid dispenser” droppers. Each liquid dispenser may be an electro-fluidic pump, syringe pump, simple tube, robotic pipettor, inkjet nozzle, acoustic ejection device, or other pressure or non-pressure driven device.”),
as in Claim 1.
Further regarding Claim 1, Umapathi does not specifically teach the apparatus discussed above wherein the controller is configured to:
receive a signal from a sensor monitoring a first droplet manipulation electrode of the plurality of droplet manipulation electrodes, the signal indicating a droplet characteristic of a first droplet on the first droplet manipulation electrode or an electrode characteristic of the first droplet manipulation electrode;
select, based on the droplet characteristic of the first droplet or the electrode characteristic of the first droplet manipulation electrode, a second droplet manipulation electrode from the plurality of droplet manipulation electrodes on which to dispense a first volume of fluid via the droplet dispenser;
position the droplet dispenser over the selected second droplet manipulation electrode; and
deposit the first volume of fluid onto the selected second droplet manipulation electrode, as in Claim 1.
However, Kim teaches a respective DMF array for laboratory droplet analysis wherein a controller is configured with the DMF array to monitor a characteristic (droplet size) of a first droplet on a first droplet manipulation electrode (See Fig. 5 and para. [0044].), and select a second electrode based on the characteristics of the first electrode to deposit a volume of fluid onto the second electrode (See Figs. 7A-D and paras. [0053-0054] discussing adding a droplet of a second solution to a second electrode based on satisfaction of the feedback system determining the size of the first droplet, so as to merge the two droplets thereby performing a dilution operation.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Umapathi wherein the controller is configured to: receive a signal from a sensor monitoring a first droplet manipulation electrode of the plurality of droplet manipulation electrodes, the signal indicating a droplet characteristic of a first droplet on the first droplet manipulation electrode or an electrode characteristic of the first droplet manipulation electrode; select, based on the droplet characteristic of the first droplet or the electrode characteristic of the first droplet manipulation electrode, a second droplet manipulation electrode from the plurality of droplet manipulation electrodes on which to dispense a first volume of fluid via the droplet dispenser; position the droplet dispenser over the selected second droplet manipulation electrode; and deposit the first volume of fluid onto the selected second droplet manipulation electrode, such as suggested by Kim, so as to enable on-chip droplet dilution operations such as serial dilutions utilized prevalently in laboratory analyses; and would have a reasonable expectation of success therein.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, modified Umapathi does not specifically teach the apparatus discussed above wherein the controller is configured to:
cause the droplet dispenser to move to a different position over a third droplet manipulation electrode of the plurality of droplet manipulation electrodes responsive to a detection from the second droplet manipulation electrode; and deposit a second volume of fluid onto the third droplet manipulation electrode, as in Claim 2.
However, as discussed above regarding Claim 1, Kim teaches adding droplets to selected electrodes of the system based on feedback signals received by a controller. Therein, one skilled in the art would find it obvious to repeat the step of droplet detection and subsequent dispensing as many times as indicated or desired for a particular assay at hand.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Umapathi wherein the controller is configured to: cause the droplet dispenser to move to a different position over a third droplet manipulation electrode of the plurality of droplet manipulation electrodes responsive to a detection from the second droplet manipulation electrode; and deposit a second volume of fluid onto the third droplet manipulation electrode, such as suggested by Kim, given that mere duplication of the detection and subsequent dispensing step would provide the expected result of another dilution performed or reagent added, which would be recognized by one skilled in the art given an assay requiring or benefiting from multiple dilutions or reagents combined; and would have a reasonable expectation of success therein.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, Umapathi teaches the apparatus discussed above wherein the controller is configured to:
cause the first volume of fluid on the second droplet manipulation electrode to merge with the second volume of fluid deposited on the third droplet manipulation electrode (Figs. 10D-F and [0069]: “…differential wetting may be used to merge two droplets…”), wherein the first volume of fluid and the second volume of fluid are different fluids ([0195]: “…droplets of two reagents may be brought together…”), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Umapathi teaches the apparatus discussed above wherein the controller is configured to:
cause the droplet dispenser to move to a different position over a third droplet manipulation electrode of the plurality of droplet manipulation electrodes absent a detection from the first droplet manipulation electrode (As Umapathi teaches the droplet dispenser 1184 as depositing droplets at any location of the electrowetting device ([0213]), and Umpathi teaches the deposition of two or more droplets ([0069]), and Umpathi teaches droplet location detection ([0189]), Umpathi thereby inherently teaches the droplet dispenser as moving to a different position over a second droplet manipulation electrode of the plurality of droplet manipulation electrodes absent a detection from the first droplet manipulation electrode. – I.e. the controller does not rely on detection for depositing droplets; as currently claimed, the first electrode need not even hold a droplet to satisfy the condition of “absent a detection”.); and cause the first volume of fluid on the second droplet manipulation electrode to move to the third droplet manipulation electrode (Figs. 10A-C and [0003]: “A set of electrode pads is arranged in an array or in paths defining one or more tracks over which liquid droplets may be induced to move over a sequence of the electrode pads.” – Further, it appears the claim is drawn to droplet merging, which is discussed in Umapathi paras. [0053-0054].), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Umapathi teaches the apparatus discussed above wherein the controller is configured to:
cause the droplet dispenser to deposit a second volume of fluid onto the third volume of fluid on the second droplet manipulation electrode (As Umapathi teaches the droplet dispenser 1184 as depositing droplets at any location of the electrowetting device ([0213]), and Umpathi teaches the deposition of two or more droplets ([0069]), and Umpathi teaches droplet location detection ([0189]), Umpathi thereby inherently teaches the droplet dispenser as depositing a second volume of fluid onto the first volume of fluid on the second droplet manipulation electrode. – See also para. [0211] which discusses dispensing directly to a droplet already located on the chip.), wherein the first volume of fluid and the second volume of fluid are different fluids (As Umapathi teaches two or more droplets of different compositions being deposited on the electrowetting device ([0174], Umapathi inherently teaches the droplet dispenser as depositing droplets onto one another, wherein the droplets have different compositions.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Umapathi teaches the apparatus discussed above further comprising a plurality of reservoirs 1164 coupled to the droplet dispenser, wherein each of the plurality of reservoirs 1164 contains a different fluid (Fig. 11I and [0184]: “Droplets may be moved from the digital microfluidic chip on to micro plates. Microplates are plates with wells that can hold samples. Microplates may have anywhere from one to a million wells on a single plate. Multiple microplates may interface with the chip in the box. To dispense droplets from the microfluidic chip to the microplate, electrowetting chips with various geometries may be used.” – Further, Fig. 11I shows various different fluids held in the wells 1164. While every well may not contain a different fluid, the microwell plate is fully capable of holding a different fluid in each well.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Umapathi teaches the apparatus discussed above wherein the controller is configured to:
transmit control signals to at least some of the plurality of droplet manipulation electrodes ([0189]: “The cameras may be used to locate droplets on the chip, to measure volumes of droplets, to measuring mixing, and to analyze reaction in progress.”), as in Claim 7.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, Umapathi does not specifically teach the apparatus discussed above wherein the controller is configured to select the second droplet manipulation electrode from the plurality of droplet manipulation electrodes based on the droplet characteristic of the first droplet, as in Claim 16.
However, Kim teaches a respective DMF array for laboratory droplet analysis wherein a controller is configured with the DMF apparatus to monitor a characteristic (droplet size) of a first droplet on a first droplet manipulation electrode (See Fig. 5 and para. [0044].), and select a second electrode based on the characteristics of the first electrode to deposit a volume of fluid onto the second electrode (See Figs. 7A-D and paras. [0053-0054] discussing adding a droplet of a second solution to a second electrode based on satisfaction of the feedback system determining the size of the first droplet, so as to merge the two droplets thereby performing a dilution operation.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Umapathi wherein the controller is configured to select the second droplet manipulation electrode from the plurality of droplet manipulation electrodes based on the droplet characteristic of the first droplet, such as suggested by Kim, so as to enable on-chip droplet dilution operations such as serial dilutions utilized prevalently in laboratory analyses; and would have a reasonable expectation of success therein.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, Umapathi does not specifically teach the apparatus discussed above wherein the controller is configured to select the second droplet manipulation electrode from the plurality of droplet manipulation electrodes based on the electrode characteristic of the first droplet manipulation electrode, as in Claim 17.
However, Kim teaches a respective DMF array for laboratory droplet analysis wherein a controller is configured with the DMF apparatus to monitor a characteristic (droplet size) of a first droplet on a first droplet manipulation electrode (See Fig. 5 and para. [0044].), and select a second electrode based on the characteristics of the first electrode to deposit a volume of fluid onto the second electrode (See Figs. 7A-D and paras. [0053-0054] discussing adding a droplet of a second solution to a second electrode based on satisfaction of the feedback system determining the size of the first droplet, so as to merge the two droplets thereby performing a dilution operation.). – See also Fig. 8A showing changing electrode characteristics used for measurement and detection.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Umapathi wherein the controller is configured to select the second droplet manipulation electrode from the plurality of droplet manipulation electrodes based on the electrode characteristic of the first droplet manipulation electrode, such as suggested by Kim, so as to enable on-chip droplet dilution operations such as serial dilutions utilized prevalently in laboratory analyses; and would have a reasonable expectation of success therein.
Response to Arguments
Claim Objections
Applicant’s amendments sufficiently overcome the objection over Claim 1 set forth in the previous office action. Accordingly, the claim rejection is hereby withdrawn.
35 USC 112
Applicant’s amendments sufficiently overcome those 35 USC 112(b) indefiniteness rejections set forth in the previous office action. Accordingly, those indefiniteness rejections under 35 USC 112(b) are hereby withdrawn.
35 USC 102
Applicant’s arguments are on the grounds that the device of Umapathi deposits droplets upon the DMF array electrodes in any arbitrary location, as opposed to the Claim 1 requirement that the device select a particular electrode on which to deposit a second droplet in response to a signal obtained from performing an analysis on a first droplet.
This is not found persuasive because the prior art reference of Kim (newly added herein as necessitated by Applicant’s amendments requiring the controller “configured to” perform the desired functions makes up for this deficiency. Kim teaches a respective DMF array wherein a feedback system monitors the droplet characteristic of droplet size and, upon the droplet size signal satisfying a predetermined voltage trigger of the electrode (Fig. 8A), the device selects second, third, etc. electrodes for depositing subsequent droplets for combining reagents with and diluting the original droplets (Figs. 7A-D). Note that while Kim teaches droplets actuated by the electrodes to reach the selected electrode as opposed to a movable dispenser depositing the droplets, Umapathi provides for the movable droplet dispenser, wherein one skilled in the art would modify the device of Umapathi with the detection and selecting capabilities of Kim while utilizing the movable dispenser of Umapathi for actually depositing droplets upon the chip.
Further note that the art of digital microfluidics is highly developed, wherein numerous devices disclose performing separate analyses based on an initial preliminary result, such as Srinivasan et al. (US 2007/0275415 A1), for example, which teaches conditional execution of controls triggered by a particular test result, such as performing a second confirmatory test ([0465]), which necessarily involves selecting electrodes and performing droplet manipulations as claimed herein. Thus, merely performing basic operations of selecting electrodes for providing droplets to merge with other droplets as claimed is routine and expected in such operations.
Applicant further argues that Claims 2-7 depend from Claim 1 and are thereby allowable in view of the alleged alloability of Claim 1.
This is not found persuasive because, as discussed above, Claim 1 is unpatentable under 35 USC 103 over Umapathi in view of Kim. Thus, Claims 2-7 are not allowable merely for their dependance on Claim 1.
New Claims
Claims 16-17 are newly added herein and rejected under 35 USC 103 over Umapathi in view of Kim. Thus, as discussed above, Claims 16-17 are not allowable merely for their dependance on Claim 1.
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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798