DETAILED ACTION
In application filed on 12/13/2022, Claims 1-18 are pending. The claim set submitted on 06/07/2023 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-6 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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 10/28/2025 is acknowledged. Claims 7-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Group I, Claims 1-6 are considered on the merits below.
Drawings
The drawings are objected to because certain reference characters in figures, not limited to Figures 2- 5 are not legible.
Further, Figures including Fig. 2, 4-7 have a low resolution. Applicant should provide Figures with improved resolution.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 3-5 are objected to because of the following informalities:
Claim 1 recites the limitation “top common electrode” in line 6 and “common top electrode” in line 17, but recites “top plate common electrode” in line 5 of the claim.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “top common electrode” in line 6 and “common top electrode” in line 17 as “top plate common electrode”.
Appropriate correction is required.
Claim 1 recites the limitation “the droplet” in line 20, but recites “a sample droplet” in line 18 of the Claim.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “the droplet” in line 20 as “the sample droplet”.
Appropriate correction is required.
Further, Claims 3-5 recites the limitation “droplet” but recites “sample droplet” in Claim 1.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “droplet” as “sample droplet”.
Appropriate correction is required.
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 1-5 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).
Regarding Claim 1, Gach teaches a method of conducting an assay comprising: taking a 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 plate 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]; interpreted as “top plate common electrode” with respect to Claim 1 objection), 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 common top electrode (referred to as controllable electrodes 130 (a first array of droplet actuation electrodes) [Para 0031; Fig. 1, ref. 130]; interpreted as “top plate common electrode” with respect to Claim 1 objection);
introducing a sample droplet (See Para 0034…the droplet inside the one or more fluidic channels 120) in 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 a droplet operation (‘transportation of the droplet’) on the sample droplet (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); and
separating the top plate from the bottom plate (See Fig. 1, refs. 105 and 125 for the separation of the top plate from the bottom plate).
Gach does not teach:
wherein at least one of the wells includes a surface that is more hydrophilic than the first hydrophobic layer; and
transferring the droplet into one of the wells, and detecting a diagnostic analyte in the droplet and optionally measuring the concentration of the analyte.
In the analogous art of a droplet actuator, and methods of making and using the droplet actuator, Pollack teaches:
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); and
transferring the droplet (See Para 0078… including one droplet in each reservoir 535) into one of the wells (‘reservoir’) (See Para 0078… FIG. 5A shows droplets 536, including one droplet in each reservoir 535), and detecting a diagnostic analyte in the droplet (See Para 0011… providing a sample droplet including substances for separation on the droplet… and providing a sample droplet may include supplying a sample droplet through the opening in the second substrate into contact with the polymerized material. The method may include marking one or more target substances for detection; Also See Para 0007… the one or more droplet operations may include steps in an assay protocol to analyze a target substance on the magnetically responsive bead, thereby teaching “detecting a diagnostic analyte in the droplet”) and optionally measuring the concentration of the analyte (the limitation “optionally measuring the …” is viewed as an optional limitation and thus not required by the claim).
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 process of wherein at least one of the wells includes a surface that is more hydrophilic than the first hydrophobic layer; and
transferring the droplet into one of the wells, and detecting a diagnostic analyte in the droplet and optionally measuring the concentration of the analyte, 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).
Regarding Claim 2, the method of claim 1 is obvious over Gach in view of Pollack. 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) is 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. Gach teaches wherein the droplet is 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. Gach teaches wherein the droplet (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).
The combination of Gach and Pollack does not teach that the droplet 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 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).
Regarding Claim 5, the method of claim 1 is obvious over Gach in view of Pollack.
The combination of Gach and Pollack does not teach that each well contains a different droplet.
In the analogous art of a droplet actuator, and methods of making and using the droplet actuator, Pollack teaches that each well (See Para 0078… FIG. 5A shows droplets 536, including one droplet in each reservoir 535) contains a different droplet (See Para 0137…the sample may be combined with magnetic beads having affinity for analytes (e.g., DNA and/or RNA) of interest; Examiner views DNA and RNA as the different droplets under BRI; Further See Para 0140…tests for bacterial and fungal pathogens (Bacillus anthracis, Franciscella tularensis, Candida albicans, Mycoplasma pneumoniae, Eschericia coli, Methicillin-resistant Staphylococcus aureus (MRSA)), human gene targets (RPL4, CFTR, PCNA) and RNA, as the different droplets; Further See Para 0136 for bacteria, viruses, and fungi).
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 process where each well contains a different droplet, as taught by Pollack for the benefit of conducting preprocessing sample having different analytes of interest (Pollack, Para 0137, 0136), 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) 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.
The combination of Gach and Pollack 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 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 and Pollack 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).
Conclusion
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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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797