DETAILED ACTION
In application filed on 12/13/2022, Claims 1-4 and 6-18 are pending. The claim set submitted on 05/27/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-4 and 6 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/2022 are 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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over by Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1).
Regarding Claim 1, Gach teaches a method of recovering material (See Para 0034…to facilitate the transportation of the droplet inside the one or more fluidic channels; See Para 0004… that may be used to dispense …droplets and/or bubbles; See Para 0040… the dispensed droplet may be conveyed or moved from dispensing region 445 through the channel 410 to a final destination, thereby teaching “recovering material” ) from a digital microfluidic device (See Abstract; Fig. 1, ref. 100… digital microfluidic systems]) comprising:
taking the digital microfluidic device (See Abstract; Fig. 1, ref. 100… digital microfluidic systems]) comprising:
(a) a top plate (referred to as top plate [Para 0009, 0031; Fig. 1, ref. 110]) comprising:
a top plate substrate (referred to as second substrate [Para 0031; Fig. 1, ref. 123]),
a top common electrode (referred to as controllable electrodes 130 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 130]);
a first hydrophobic layer (referred to as second hydrophobic layer [Para 0035; Fig. 1, ref. 180]) covering (See Fig. 1…for covering) the top common electrode (referred to as controllable electrodes 130 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 130]), and
a plurality of wells (See Para 0040; Fig. 4, ref. 420 for the plurality of reservoirs)
(b) a bottom plate (referred to as bottom plate [Para 0009, 0031; Fig. 1, ref. 105]) comprising:
a bottom electrode array (referred to as a patterned array of controllable electrodes 125 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 125]) comprising a plurality of digital microfluidic propulsion electrodes (See Para 0031; Fig. 1, ref. 125… a patterned array of controllable electrodes 125 (a first array of droplet actuation electrodes; Examiner views the limitation “propulsion” as intended use. See MPEP 2114) and
a second hydrophobic layer (referred to as first hydrophobic layer [Para 0035; Fig. 1, ref. 175]) covering (See Fig. 1…for covering) the bottom electrode array (referred to as a patterned array of controllable electrodes 125 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 125]);
wherein the top plate (referred to as top plate [Para 0009, 0031; Fig. 1, ref. 110]) and the bottom plate (referred to as bottom plate [Para 0009, 0031; Fig. 1, ref. 105]) are provided in a spaced relationship (See Fig. 1, ref. 112…distance gap) defining a microfluidic region (referred to as one or more fluidic channels 120 [Para 0034; Fig. 1, ref. 120]) therebetween to permit droplet motion (See Para 0034…to facilitate the transportation of the droplet inside the one or more fluidic channels 120) within the microfluidic region (referred to as one or more fluidic channels 120 [Para 0034; Fig. 1, ref. 120]) under application of propulsion voltages (See Para 0034…when the electric voltage is applied to the group of electrodes (A), (B), (C), (D),) between the bottom electrode array (referred to as a patterned array of controllable electrodes 125 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 125]) and the top common electrode (referred to as controllable electrodes 130 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 130]);
introducing sample droplets (See Para 0034…the droplet inside the one or more fluidic channels 120; See Para 0033…one or more droplets may be manipulated (serially or simultaneously) by the digital microfluidic system 100; See Para 0034… The droplet and/or bubble 167, 170 may comprise a sample (e.g., a biochemical, chemical, biological, etc. sample)) into the microfluidic region (referred to as one or more fluidic channels 120 [Para 0034; Fig. 1, ref. 120]) of the digital microfluidic device (See Abstract; Fig. 1, ref. 100… digital microfluidic systems]);
performing droplet operation (‘transportation of the droplet’) on the sample droplets (See Para 0034…facilitate the transportation of the droplet inside the one or more fluidic channels 12; See Para 0027… various embodiments disclosed herein are directed to techniques for manipulating droplets (e.g., dispense, transport, split, and merge droplets) on a droplet transport layer using minimal connections to an array of droplet actuation electrodes) to bring the sample droplets into contact (See Para 0040…a droplet being dispensed from the reservoir 420, thereby teaching “droplet in contact”; See Para 0033…one or more droplets may be manipulated (serially or simultaneously) by the digital microfluidic system 100) with the wells (See Para 0040; Fig. 4, ref. 420 for the plurality of reservoirs), where each well contacts at most a single droplet of the sample droplets (See Para 0040…a droplet is dispensed from the reservoir 420, thereby teaching “each well contacts at most a single droplet of the sample droplets”).
Gach does not teach:
(a) a removable top plate;
wherein at least one of the wells includes a surface that is more hydrophilic than the first hydrophobic layer.
In the analogous art of a droplet actuator, and methods of making and using the droplet actuator, Pollack teaches:
(a) a removable top plate (referred to as top member [Fig. 1A, ref. 110]; Also See Para 0057… top member 110 may be coupled by a flexible hinge portion or member 115, thereby teaching “removable”);
wherein at least one of the wells (referred to as reservoir [Para 0078; Fig. 5A, ref. 535]) includes a surface that is more hydrophilic (See Para 0078… Further, the surface of reservoir 525 and/or reservoir 535 may also be hydrophobic or coated with a hydrophobic material) than (See Para 0024… In some cases, droplet operations are further facilitated by the use of hydrophilic and/or hydrophobic regions on surfaces …, thereby teaching “than”) the first hydrophobic layer (referred to as protective film 205 [Para 0058, 0088, 0078]; See Para 0070… the protective film may double as a hydrophobic layer; See Para 0063… A hydrophilic coating (not shown) may, in some cases, be provided atop protective film 205).
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 the method of Gach to incorporate a method having a removable top plate; and wherein at least one of the wells includes a surface that is more hydrophilic than the first hydrophobic layer, as taught by Pollack for the benefit of placing the droplet into the reservoirs (Pollack, Para 0078), which allows the provision of a method including using the droplet to conduct an assay analyzing a component of the sample. In some cases, the assay analyzes a protein or peptide present in the sample. In some cases, the assay may include amplifying a nucleic acid present in the sample (Pollack, Para 0009).
The combination of Gach and Pollack does not teach “removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells”.
In the analogous art of a microplate lid containing fluid processing and transport structures is disclosed that provides controlled delivery of small volumes of samples and reagents to a microplate, and prevents evaporation during processing, Mcneely teaches “removing the removable top plate (‘by removing the lid,’) in order to recover at least a portion of the sample droplets (‘fluid or liquid’) in contact with the wells (See Page 3, line 25…wells)” ( See Page 3, lines 29-33…The lid may be designed to extract liquid from a well and deliver it to an integrated microdetection system, such as a microelectrophoresis system, or, by removing the lid, the fluid in the well may be available for conventional extraction and transfer to another external system. Micro beads often used in some chemical processes could also be present and easily contained in a well).
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 the method of Gach and Pollack to incorporate “removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells”, as taught by Mcneely for the benefit of extracting liquid from a well and deliver it to an integrated microdetection system, such as a microelectrophoresis system (Mcneely, Page 3, lines 29-30), which allows for the provision of enhanced function to microplates, such as improved sample and reagent fluid processing capability, while retaining the same basic format for compatibility with existing equipment (Mcneely, Page 2, lines 23-25).
Regarding Claim 2, the method of claim 1 is obvious over Gach in view of Pollack and further in view of Mcneely.
Gach teaches that the droplet operation (See Para 0034…facilitate the transportation of the droplet inside the one or more fluidic channels 12; See Para 0027… various embodiments disclosed herein are directed to techniques for manipulating droplets (e.g., dispense, transport, split, and merge droplets) on a droplet transport layer using minimal connections to an array of droplet actuation electrodes) are selected from the group consisting of merging, incubating, agitating, mixing, diluting, splitting, and combinations thereof (See Para 0027… various embodiments disclosed herein are directed to techniques for manipulating droplets (e.g., dispense, transport, split, and merge droplets) on a droplet transport layer using minimal connections to an array of droplet actuation electrodes).
Regarding Claim 3, the method of claim 2 is obvious over Gach in view of Pollack and further in view of Mcneely.
Gach teaches wherein the sample droplets (See Para 0034…the droplet inside the one or more fluidic channels 120; See Para 0033…one or more droplets may be manipulated (serially or simultaneously) by the digital microfluidic system 100) include a biological sample (See Para 0034… The droplet and/or bubble 167, 170 may comprise a sample (e.g., a biochemical, chemical, biological, etc. sample).
Regarding Claim 4, the method of claim 1 is obvious over Gach in view of Pollack and further in view of Mcneely.
Gach teaches wherein the sample droplets (See Para 0034…the droplet inside the one or more fluidic channels 120; Further See Para 0034… The droplet and/or bubble 167, 170 may comprise a sample (e.g., a biochemical, chemical, biological, etc. sample; See Para 0033…one or more droplets may be manipulated (serially or simultaneously) by the digital microfluidic system 100).
The combination of Gach and Mcneely does not teach that the sample droplets includes a nucleic acid molecule.
In the analogous art of a droplet actuator, and methods of making and using the droplet actuator, Pollack teaches that the droplet includes a nucleic acid molecule (See Para 0009… The droplet may include a non-aqueous droplet. The method may include using the droplet to conduct an assay analyzing a component of the sample. … the assay may include amplifying a nucleic acid present in the sample. The method may include removing the droplet from the droplet actuator; Further See Para 0012, 0014-0015, 0022).
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 the method of Gach and Mcneely to incorporate a process where the droplet includes a nucleic acid molecule, as taught by Pollack for the benefit of amplifying a nucleic acid present in the sample placing the droplet into the reservoirs (Pollack, Para 0009, 0012, 0014-0015, 0022), which allows the provision of a method including using the droplet to conduct an assay analyzing a component of the sample. In some cases, the assay analyzes a protein or peptide present in the sample. In some cases, the assay may include amplifying a nucleic acid present in the sample (Pollack, Para 0009).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1) as applied to claim 1 above, and further in view of Naessens et al. (US20120031176A1).
Regarding Claim 6, the method of claim 1 is obvious over Gach in view of Pollack and further in view of Mcneely.
The combination of Gach, Pollack and Mcneely does not teach that the contact angle ϴ of the well surface is in the range 0 < ϴ < 5O.
In the analogous art of the field of microfluidics characterisation. More particularly the present invention relates to methods and devices for characterisation of microliter amounts of fluids, Naessens teaches that the contact angle ϴ (See Para 0042… Applying a hydrophilic coating assists in obtaining a contact angle) of the well surface (See Para 0042… the walls or some of the walls of the input well 110…may be hydrophilised) is in the range 0 < ϴ < 5O (See Para 0042… In some embodiments, the hydrophilic coating may be selected so that a contact angle between 80° and 0 is obtained).
While the combination of Gach, Pollack, Mcneely and Naessens does not explicitly teach that the contact angle ϴ of the well surface is in the range 0 < ϴ < 5O, Naessens teaches that the contact angle ϴ of the well surface is in the range 0 < ϴ < 5O by using an overlapping range disclosure (See Para 0042… Applying a hydrophilic coating assists in obtaining a contact angle smaller than 90°. In some embodiments, the hydrophilic coating may be selected so that a contact angle between 80° and 0 is obtained).
As a result, since the claimed limitation overlap the range disclosed by the prior art, a prima facie case of obviousness exists. Please see MPEP 2144.05 (I) and In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976) for further details.
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 the method of Gach, Pollack and Mcneely to have the contact angle ϴ of the well surface to be in the range 0 < ϴ < 5O as taught by Naessens, for the benefit of obtaining capillary forces on the surfaces of the walls or some of the walls of the input well 110, the storage chamber 140 and the throughput channel 130 which are hydrophilized (Naessens, Para 0042), allowing for the provision of good devices with improved accuracy and methods for characterizing microliter amounts of fluids(samples) or assisting therein. (Naessens, Para 0005).
Response to Arguments
Applicant's arguments filed on 05/27/2026, with respect to the objections to the drawings filed 12/13/2022 have been fully considered and are persuasive.
Without acceding to the propriety of the objection and solely in the interest of furthering prosecution, Applicant files Replacement Sheets herewith to replace the previously-filed FIGs. 1-7. The Replacement Sheets merely provide for improved legibility, compliance with 37 CFR § 1.84, and/or resolution. No new matter is added.
Applicant submits that entry of the Replacement Sheets filed herewith complies with the manner of making amendments to the drawings as set forth in 37 C.F.R. § 1.121(d). Therefore, entry of the Replacement Sheets and withdrawal of the objections to the drawings is respectfully requested. Applicant's understanding is that the Replacement Sheets filed herewith fully address the objections of the Office Action.
Examiner respectfully agrees and the objections to the drawings filed 12/13/2022 are withdrawn.
Applicant's arguments filed on 05/27/2026, with respect to the objections to Claims 1 and 3-5 have been fully considered and are persuasive.
Applicant submits that Claim 1 is objected to as allegedly using inconsistent language due to previously reciting a "top plate common electrode" and a "top common electrode". Without acceding to the propriety of the objection and solely in the interest of furthering prosecution, amended claim 1 replaces "top plate common electrode" with "top common electrode".
Applicant submits that Claim 1 is further objected to as allegedly using inconsistent language due to previously reciting a "sample droplet" and a "droplet". Without acceding to the propriety of the objection and solely in the interest of furthering prosecution, amended claim 1 removes recital of "the droplet" as in line 20 of previous claim 1.
Applicant submits that Claims 3-5 are objected to as allegedly using inconsistent language due to previously reciting a "droplet" rather than a "sample droplet". Without acceding to the propriety of the objection and solely in the interest of furthering prosecution, amended claims 3-4 recite "sample droplets". Claim 5 is cancelled, rending moot the objection to claim 5. Accordingly, withdrawal of the objections to the claims is respectfully requested.
Examiner respectfully agrees and the objections to claim 1 and 3-5 are withdrawn.
Applicant’s arguments, see Page 9, filed 05/27/2026, with respect to the rejection(s) of claim(s) 1-5 under 35 U.S.C. §103 (Claim 5 is cancelled, rendering the rejection of Claim 5 moot) 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 for amended Claim 1 by Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1).
Applicant submits that Gach does not disclose a removable top that is plate separable from a bottom plate. In other words, Gach's top and bottom plates appear configured to remain attached to each other. Moreover, Gach does not appear to disclose, teach, or suggest anything related to "recover at least a portion of the sample droplets in contact with the wells" as further required by amended claim 1. For the sake of clarity, Applicant submits that it does not appear possible to remove Gach's top plate from Gach's bottom plate "in order to recover at least a portion of the sample droplets" therebetween; if such a plate removal were even possible without destroying Gach's device, Applicant submits that it would require a disruptive disassembly process through which respective sample droplets possibly existing between the plates would not survive…Without acceding to the propriety of these assertions, Applicant submits that Pollack generally pertains to a "droplet actuator" including "a reagent storage cassette" for loading fluid into a "droplet operations gap" (see Pollack, at claim 174). Pollack is not asserted to show, nor does Pollack appear to disclose, teach, or suggest, the claimed "removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells".
Applicant therefore submits that Pollack fails to bridge the factual deficiencies of Gach as set forth above with respect to at least the claimed "removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells." Moreover, one skilled in the art would not be motivated to modify Pollack to include a removable top plate or to separate discrete droplets as recited in claim 1. Pollack is concerned with a reagent transfer or holding device to then transfer to a bead or droplet to perform digital microfluidic operations. Pollack's device is not for recovery of samples from the digital microfluidic operations to run operations on the resulting products. Further, the hydrophobic films in the case of Pollack are designed to seal in the stored reagents, not to keep separate discrete droplets that have been given different properties by digital microfluidic operations.
Accordingly, for at least the foregoing reasons, Applicant submits that amended claim 1 is patentable over Gach in view of Pollack. Dependent claims 2-4 require all the limitations of amended claim 1 and are therefore patentable over Gach in view of Pollack for at least the same reasons. Withdrawal of the outstanding rejections to claims 1-4 under 35 U.S.C. § 103 is respectfully requested.
Applicant’s arguments with respect to amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 1 is taught as disclosed in the rejection of amended Claim 1 (Supra) by Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1).
Accordingly, the combination of Gill, Pollack and Mcneely discloses the method of recovering material from a digital microfluidic device comprising: “removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells”. as recited in the rejection of amended claim 1.
Applicant’s arguments, see Page 11, filed 05/27/2026, with respect to the rejection(s) of claim(s) 6 under 35 U.S.C. §103 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 for Claim 6 with respect to amended Claim 1 by Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1) as applied to claim 1 above, and further in view of Naessens et al. (US20120031176A1).
Applicant submits that Naessens is relied on in the rejection of claim 6 as allegedly teaching "the contact angle 0 of the well surface is in the range 0° < 0 < 5°". Without acceding to the propriety of this assertion, Applicant submits that Naessens fails to bridge the factual deficiencies of Gach and Pollack as set forth above with respect to at least the claimed "removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells."
Accordingly, for at least the foregoing reasons, withdrawal of the outstanding rejection to claim 6 under 35 U.S.C. § 103 is respectfully requested.
Applicant’s arguments with respect to Claim 6 in view of amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of Claim 6 in view of amended Claim 1 is taught as disclosed in the rejection of Claim 6 (Supra) by Gach et al. (US20190126280A1) in view of Pollack et al. (US20150027889A1, submitted in IDS on 12/13/2022) and further in view of Mcneely et al. (WO2002072423A1) as applied to claim 1 above, and further in view of Naessens et al. (US20120031176A1).
Accordingly, the Mcneely reference is used to the claimed "removing the removable top plate in order to recover at least a portion of the sample droplets in contact with the wells."
As such the combination of Gach, Pollack, Mcneely and Naessens teaches Claim 6 limitations.
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 OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (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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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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