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 .
Priority
This application is a continuation of PCT/US2023/068253, filed 06/09/2023 and published as WO 2023/240276 A1 on 12/14/2023.
This application claims benefit of U.S. provisional application 63/350,835, filed 06/09/2022.
Response to Amendment
Claims 76-95 are pending as filed in the amendment dated 07/17/2025.
Information Disclosure Statement
The Primary Examiner has considered the IDS filed 02/04/2025.
Drawings
The drawings filed 12/09/2024 are acceptable. See MPEP § 608.02(b)(I).
Specification
Abstract
The abstract of the disclosure is objected to because: (i) it uses phrases which can be implied (e.g., “The present disclosure describes”); (ii) it refers to the purported merits of the invention (e.g., “increased force applied to the fluid, better fluid position accuracy, improved fluid movement reliability, increased maximum fluid movement speed, resilience against surface fouling, resistance against fluid pinning”); and (ii) fails to recite and process steps. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 87 is objected to because of the following informalities: (i) in line 3 of the claim, “polyphenylene Sulfide” should read “polyphenylene sulfide;” (ii) in lines 6-7 of the claim, “Polyphenyl ether” should read “polyphenyl ether.” Appropriate correction is required.
Claim 95 is objected to because of the following informalities: in the penultimate line of the claim, “encepbaloscope” should read “encephaloscope.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 87 and 95 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 87 and 95, the parenthetical phrases beginning "e.g., . . .” renders the claim indefinite because it is unclear whether the limitation(s) following the parenthetical phrases are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 76-95 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0114360 A1 (“US 360”) in view of EITHER Abdelgawad et al., Low-cost, rapid-prototyping of digital microfluidics devices, Microfluid Nanofluid (2008) 4:349-355 (“Abdelgawad”) OR WO 2021/041709 A1 (“WO 709”), further in view of Barman et al., Electrowetting on dielectrics on lubricating fluid-infused smooth/rough surfaces with negligible hysteresis, Journal of Adhesion Science and Technology, 2017, Vol. 31, No. 2, 159-170 (“Barman”).
Claim 76
US 360 teaches a method (Para. [0007]: In general, in a fifth aspect, the invention features a method. A liquid droplet is introduced into a surface over a set of electrode pads arranged in an array) of coating a surface (Para. [0008]: The surface may be smoothed to within 1 micron by applying a coating . . . . The surface coating may be of a material that is both dielectric and hydrophobic) for contacting a fluid (Para. [0007]: The varying-wettability portions are 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 varying-wettability portions) comprising:
applying a film layer to said surface (Para. [0121]: a thin polymer film (1 micron to 20 microns) may be used to form a smooth dielectric surface directly above the electrode array) wherein said film layer is non-textured (Para. [0121]: In these cases, the film is first stretched to remove any wrinkles and is then bonded to the surface of the electrodes. Polymer films of low surface free energy may be used for such use; Para. [0008]: The surface may be smoothed to within 1 micron by applying a coating);
applying a liquid layer to said film layer (Para. [0123]: this slippery surface may be created by creating a thin layer of lubricating liquid on the smooth dielectric; Para. [0150]: The lubricating oil may be any low-energy oil such a silicone oil).
US 360 does not teach: (i) that the surface also comprises a silicone oil gap-filling liquid; (ii) that the liquid layer has a viscosity of about 0.5 cSt to about 100 cSt; or (iii) that the liquid layer has an initial thickness ranging from about 0.01 micron to about 500 microns.
With respect to (i), Abdelgawad teaches a process for forming a microfluidic device for manipulating liquid droplets based on a substrate having an array of electrodes (etched copper printed circuit) [§2.3], a polymer dielectric film thereon, and a lubricating liquid [§2.4]. In the process of manufacturing this microfluidic device, Abdelgawad teaches placing a few drops of silicone oil onto the surface of the electrode array (inherently filling the gaps therebetween). “The film of oil helps prevent the trapping of air bubbles, and reduces the likelihood of the [polymeric film’s] wrinkling on the device surface” [§2.4]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the process of US 360 so as to apply a silicone oil gap-filling liquid over the set of electrode pads arranged in an array before the application of the polymer film layer. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of reducing or eliminating air bubbles that might cause wrinkling of the polymeric film, thereby ensuring a smooth surface over which liquid droplets can move.
In the alternative, with respect to (i), WO 709 teaches a process for the manufacture of a device for the microfluidic processing of droplets biological samples by manipulation through electrowetting – using electric fields from electrodes to move the droplet adjacent to the surface of the device [0003]. WO 709 teaches that, in a substrate having an electrode array and a film thereover, similar to the devices of US 360, Abdelgawad, and WO 709, “a filler fluid 10350 is used to ensure good adhesion between the film layer and the substrate. A thin layer of filler fluid 10305 may be placed between the electrode array 10320 and the bottom film layer 10335 . . . through surface tension, removes any air gaps. Filler fluids may include a variety of insulating materials including silicone oil or fluorinated oils” [0432]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the process of US 360 so as to apply a silicone oil gap-filling liquid over the electrode array before the application of the polymer film. One of ordinary skill in the art would have been motivated to improve the adhesion between the substrate and the polymeric film layer, thereby ensuring a durable microfluidic device.
With respect to (ii) and (iii), Barman teaches broadly that electrowetting properties of a drop on a smooth dielectric-coated (EWOD) substrate are affected by the viscosity of the lubricating fluid [abstract and ¶ beginning at the bottom of p. 164 ff.]. Specifically, a the lower the viscosity of the lubricating fluid, the lower the threshold voltage [Fig. 4]. Specifically, Barman teaches silicone oils with viscosities of approximately 20, 100, and 350 cSt at a thickness of approximately 3 microns [Experimental Setup]. The experimental viscosities of 20 cSt and 100 cSt are within the claimed viscosity range of about 0.5 cSt to about 100 cSt. The experimental thickness of approximately 3 microns is within the claimed range of about 0.01 micron to about 500 microns. See MPEP § 2131.03. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the process of US 360 in view of Abdelgawad or WO 709 so as to utilize a silicone oil having a viscosity of 20, 100, or 350 cSt, and a layer thickness of 3 microns. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully making an EWOD device because these viscosities and thicknesses are known in the art as suitable for EWOD.
Moreover, in the alternative, Barman teaches that the viscosity of the silicone oil is a result-effective variable affecting the threshold voltage [supra]. Consequently, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the viscosity of the silicone oil by routine experimentation, absent evidence of criticality. See MPEP § 2144.05(II). It is the Primary Examiner’s position that this thickness of the silicone oil is a result-effective variable, too. The layer must be thick enough to provide the desired movement properties, but not so thick as to be wasteful of material or otherwise detrimental to the coating process or subsequent use of the device, such as impeding droplet mobility. Consequently, it would have also been obvious to one of ordinary skill in the art to optimize the silicone oil layer thickness by routine experimentation, absent criticality, as well.
Finally, see US 360 at [0150], which teaches “[t]he viscosity of the lubricating oil affects droplet mobility during electrowetting; with lower viscosity promoting higher mobility.” Here, too, is a teaching of the result-effective nature of the viscosity of the viscosity of the silicone oil further supporting the Primary Examiner’s position that it would have been obvious to one of ordinary skill in the art to optimize the viscosity by routine experimentation so as to achieve the desired level of droplet mobility. Nothing in the record to date indicates that the optimization of the viscosity of the silicone oil would be “anything other than the exercise of ordinary skill in the art.” In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012).
Claim 77
As noted above, US 360 teaches that the surface may be smoothed to within 1 micron by applying a coating [0008].
Claims 78-80
US 360 teaches that the liquid layer is a lubricating layer (Para. [0123]: this slippery surface may be created by creating a thin layer of lubricating liquid on the smooth dielectric; Para. [0150]: The lubricating oil may be any low-energy oil such as silicone oil, DuPont Krytox oil, Fluorinert FC-70, or other oil).
Claims 81-82
US 360 does not expressly teach that the liquid layer comprises an additive, or that the additive is a rheology modifier, filler, solvent, surfactant, dye, or combinations thereof.
Nevertheless, US 360 teaches at [0150]: “[t]he viscosity of the lubricating oil affects droplet mobility during electrowetting; with lower viscosity promoting higher mobility.” As has been established above, it would have been obvious to one of ordinary skill in the art to optimize the viscosity of the silicone oil by routine experimentation. It is the Primary Examiner’s position that such optimization would extend to the use, if necessary or desired, of a rheology modifier additive.
Claims 83-85
US 360 does not explicitly teach the limitations of these claims. Nevertheless, it is the Primary Examiner’s position that these limitations are physical properties of the liquid layer. Since the instant application discloses and the prior art teaches silicone oil as the liquid layer, that liquid layer necessarily possesses the characteristics recited in these claims. See MPEP § 2112.01.
Claims 86-87
US 360 teaches that the polymeric film having low surface energy can be used, including PTFE, ETFE FEP, PFA, other fluoropolymers, PDMS, and other polymers with low surface energy suitable for electrowetting [0121].
Claim 88
US 360 teaches that the polymer film has a thickness of 1 micron to 20 microns [0121]. This range falls completely within the claimed range of about 0.1 micron to about 1000 microns and a prima facie case of obviousness exists. MPEP § 2144.05(I).
Claims 89-91
US 360 teaches that the low surface energy polymer film may sometimes need an additional layer of hydrophobic material to reduce surface energy further for low adhesion and good electrowetting (i.e., modifying the film layer to increase affinity of the liquid layer for the film by application of a secondary coating) [0121].
Claims 92-94
US 360 teaches that, “as droplets are transported . . ., the droplets may carry and deplete the oil film from the surface. The oil on the surfaces may be replenished by injecting oil from an external reservoir; for example, from an inkjet cartridge, syringe pump or other dispensing mechanisms. The lubricating surface may be washed away entirely and replaced with a fresh layer of oil to prevent cross contamination between two consecutive experiments.” [0171-0172]. The silicone oil is intended to facilitate electrowetting of droplets and so is intended to be contacted with a fluid.
It is the Primary Examiner’s position that the silicone oil’s being removeable/replaceable and being permanent, within the context of electrowetting, is a difference of degree and not of kind. If the silicone oil remains in place for as long as desired for device usage, it is permanent. If the oil becomes contaminated or is lost, it may be removed/replaced.
Claim 95
US 360 teaches that the electrowetting layers “may include stations for one or more of, or two or more of, or three or more of, or four or more of, the group consisting of dispensing, mixing, heating, cooling, application of magnetic field, application of electric field, addition of reagent, optical inspection or assay, and isolation or purification of proteins, peptides, or any other biopolymer” [0008]. It is the Primary Examiner’s position that this teaching reads on at least the claimed biosensor (“other protein or enzyme sensors”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cao et al., Electrowetting on liquid-infused membrane for flexible and reliable digital droplet manipulation and application, Sensors and Actuators B: Chemical, Volume 291, 2019, Pages 470-477, ISSN 0925-4005, https://doi.org/10.1016/j.snb.2019.04.102 — This reference teaches digital microfluidic devices based on electrowetting-on-dielectric (EWOD). The EWOD device consists of two flexible conductive films as top and bottom electrodes, and one flexible liquid-infused membrane (LIM) as the hydrophobic insulating layer. LIMs made by infusing various fluids (air, fluorocarbon, silicone and hydrocarbon oils) into polytetrafluoroethylene (PTFE) membranes are evaluated by electrowetting performance of a sessile water droplet. Silicone oil is selected as the filling insulating oil according to its excellent electrowetting performance in good reversibility, low contact angle hysteresis, and negligible volatility. The factors affecting droplet transport velocity are investigated, including the infused oil viscosity. This reference differs from the instant claims in that it fails to teach a silicone oil gap filler. This reference differs from the instant disclosure in that it teaches top and bottom electrodes, instead of a single electrode. Moreover, it does not teach a non-EWOD surface such as the many medical devices and implants recited in claim 95.
Kleinert et al., The dynamics and stability of lubricating oil films during droplet transport by electrowetting in microfluidic devices, Biomicrofluidics 9, 034104 (2015) — This reference teaches that the operation of digital microfluidic devices with water droplets manipulated by electrowetting is critically dependent on the static and dynamic stability and lubrication properties of the oil films that separate the droplets from the solid surfaces. This reference differs from the instant claims in that it fails to teach a silicone oil gap filler. This reference differs from the instant disclosure in that it teaches top and bottom electrodes, instead of a single electrode. Moreover, it does not teach a non-EWOD surface such as the many medical devices and implants recited in claim 95.
Wang et al., Effect of lubricant viscosity on the self-healing properties and electrically driven sliding of droplets on anisotropic slippery surfaces, J. Mater. Chem. A, 2018, 6, 3414-3421 — This reference teaches anisotropic slippery surfaces designed and prepared with directional, porous and conductive PCDTPT films and lubricants (silicone oils with different viscosities), which are used to investigate the influencing factors of the self-healing properties and electrically driven droplet motion. The results elucidate that the critical self-healing thickness increases with increasing silicone oil viscosity and that low-viscosity silicone oils filling in the porous films can reduce the responsive voltage of the electrical control of droplet motion on the anisotropic slippery surfaces with the same lubricant layer thickness. This reference differs from the instant claims in that it fails to teach a silicone oil gap filler. Moreover, it does not teach a non-EWOD surface such as the many medical devices and implants recited in claim 95.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM P FLETCHER III whose telephone number is (571)272-1419. The examiner can normally be reached Monday-Friday, 9 AM - 5 PM.
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WILLIAM PHILLIP FLETCHER III
Primary Examiner
Art Unit 1759
/WILLIAM P FLETCHER III/Primary Examiner, Art Unit 1759
29 January 2026