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 .
DETAILED ACTION
The Examiner of your application has changed. Please address future correspondence to Amy M. Bunker, AU1684.
Pursuant to a preliminary amendment filed December 1, 2025, claims 1, 3, 6, 8-10, 16, 18-20, 27, 29, 32-37, 51-54, 56 and 69-71 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election with traverse of Group V, claims 69-71, directed to a system for performing high throughput screening, in the reply filed December 1, 2025 is acknowledged.
Response to Traversals:
The traversal of is on the grounds that: (a) Banerjee does not disclose the method of preparing of the core-shelled bead disclosed by Applicant (Applicant Remarks, pg. 13, third full paragraph)
Regarding (a), as noted in the Requirement for Restriction/Election mailed October 2, 2025, Groups I-V lack unity of invention under PCT Rule 13.1 because they do not share the same or corresponding special technical feature, and are not linked by a single general inventive concept. Therefore, they do not meet the requirement of unity of invention in accordance with PCT Rules 13.1, 13.2 and 13.3. For example, Groups I-V do not recite preparing a core-shell bead (Group I and Group II recites an emulsion and a fluorinated silica nanoparticle; Group III recites a method of preparing a copolymer resin; Group IV recites a core-shell bead, and Group V includes a core-shell bead, a thin-shelled bead, and a copolymer resin, such that all of the Groups do not share the same or corresponding special technical feature, and are not linked by a single general inventive concept. Thus, the restriction is proper.
Claims 1, 3, 6, 8-10, 16, 18-20, 27, 29, 32-37, 51-54 and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 1, 2025.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 69-71 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed September 11, 2023, is a 35 U.S.C. 371 national stage filing of
International Application No. PCT/IB2022/05224, filed March 9, 2022, which claims the benefit of US Provisional Patent Application 63291637, filed December 20, 2021; and US Provisional Patent Application 63160641, filed March 12, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 15, 2023 has been considered. An initialed copy of the IDS accompanies this Office Action.
Claim Objections/Rejections
Product-by-Process
Please Note: instant claims 69-71 are determined to be product-by-process claims. The structural elements of the system, comprising: (i) a continuous phase formulation comprising a fluorous dispersion oil and droplet stabilizer as recited; (ii) a solid support selected from the group consisting of a PEGA copolymer resin, a thin-shelled bead, and a core-shell bead; and (iii) a sorter as recited is not considered to limit the system of claims 69-71, such that it is assumed that equivalent systems comprising a continuous phase formulation, solid support, and a sorter are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. Moreover, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Claim Objection
Claims 69-71 are objected to because of the following informalities: Claims 69-71 recites the term "PEG” in claim 69, lines 24-25, where an abbreviation should be spelled out in the first encounter of the claims. Appropriate correction is required.
Drawing Objection
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description:
Figure 1b: appears to illustrate a plurality of picoliter droplets, each comprising a UPC-E barcode (e.g., printed barcodes comprising linear lines), as opposed to, nucleic acid barcodes. The presence of UPC-E barcodes in each microdroplet is not identified in the as-filed Specification, filed September 11, 2023.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 Rejections - 35 USC § 112(b)
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 69-71 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 69-71 are indefinite for the recitation of the term “the fluorous dispersion oil” such as recited in claim 69, line 4. There is insufficient antecedent basis for the term “the fluorous dispersion oil” in the claim because claim 69, line 3 recites the term “at least one fluorous dispersion oil.”
Claims 69-71 are indefinite for the recitation of the term “the monomers” such as recited in claim 69, lines 20 and 21. There is insufficient antecedent basis for the term “the monomers” in the claim because claim 69, line 13 recites the term “a first plurality of monomers.”
Claims 69-71 are indefinite for the recitation of the term “a PEGA co-polymer resin” such as recited in claim 69, line 21. There is insufficient antecedent basis for the term “a PEGA co-polymer resin” in the claim because claim 69, lines 8-9 recites the term “a monodisperse polyethylene glycol acrylamide (PEGA) co-polymer resin.”
Claims 69-71 are indefinite for the recitation of the term “functionalization handle” such as recited in claim 69, lines 25-28 because the structure of the co-polymer resin is unclear. More specifically, it is unclear whether the mono-acrylamide PEG and/or the mono-acrylamide diamine comprise a “functionalization handle” after polymerization is complete (e.g., the handle is available for further functionalization); and/or whether either “functionalization handle” undergoes functionalization, bond formation, etc. during polymerization such that a handle is unavailable for reaction in the final co-polymer resin and, thus, the metes and bounds of the claim cannot be determined.
Claims 69-71 are indefinite for the recitation of the terms “polymerizing the monomers,” such as recited in claim 69, line 36. There is insufficient antecedent basis for the term “the monomers” in the claim because claim 69, line 30 recites the term “a second plurality of monomers.”
Claims 70 and 71 are indefinite for the recitation of the term “the continuous phase formulation comprises, “PEGA co-polymer resin is prepared by,” “the core-shell bead is prepared by,” and “the thin-shell bead is prepared by” such as recited in claim 70, lines 3, 11-12 and 29 because claims 70 and 71 depend from instant claim 69, wherein claim 69 already recites what the ‘continuous phase formulation’ comprises and/or how each of the resins or beads is prepared, such that dependent claims 70 and 71 cannot recite that it comprises anything different from (or in addition to) the independent claim and, thus, the metes and bounds of the claim cannot be determined.
Claim 70 is indefinite for the recitation of the terms “the first electrode” and “the second electrode” such as recited in claim 70, lines 46 and 49-50. There is insufficient antecedent basis for the terms “the first electrode” and “the second electrode” in the claim because claim 70, line 44 recites the term “first and second electrodes.” The Examiner suggests that Applicant amend claim 70 to recite, for example, “a first electrode and a second electrode.”
Claim 70 is indefinite for the recitation of the terms “the first outlet channel” and “the second outlet channel” such as recited in claim 70, lines 47-48 and 51. There is insufficient antecedent basis for the terms “the first outlet channel” and “the second outlet channel” in the claim because claim 70, line 43 recites the term “first and second outlet channel.”
Claim 70 is indefinite for the recitation of the terms “voltage” and “one or more target compositions” such as recited in claim 70, lines 46, 49 and 50 because claim 70 depends from claim 69, wherein claim 69 does not recite the presence of any ‘voltage,’ the application of a voltage, and/or ‘one or more target compositions’ in the system and, thus, the metes and bounds of the claim cannot be determined.
Claim 71 is indefinite for the recitation of the terms “one microdroplet,” “assay droplets,” “desired droplets” and “multiple desired droplets” such as recited in claim 71, lines 40, 42 and 45 because claim 71 depends from claim 69, wherein claim 69 does not recite the presence of “microdroplets,” “assay droplets,” “desired droplets,” and/or “multiple desired droplets” in the systems. Moreover, the difference between the recited droplets is unclear and, thus, the metes and bounds of the claim cannot be determined.
Claim 71 is indefinite for the recitation of the term “to hit wells” such as recited in claim 71, line 45 because it is unclear whether the term is describing a type of well within the microwell array plate; or whether the term is describing a process and/or an ability of the droplet sampling device to successfully deposit desired droplets into wells (e.g., the ability to hit a well during deposition). Moreover, claim 71 depends from claim 69, where claim 69 does not recite the presence of “hit wells” and, thus, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 70 and 71 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 70 recites (in part): “the continuous phase formulation comprises…a first state, in which the first electrode receives more voltage than the second electrode, that causes one or more target compositions flowing through the junction…to enter the second outlet channel” in lines 3-51 because claim 70 depends from instant claim 69, wherein claim 69 already recites what the continuous phase formulation comprises. Additionally, claim 69 does not recite a system comprising the presence of a voltage, one or more target compositions, anything flowing through the sorter, etc. Thus, claim 70 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 71 recites (in part): “the continuous phase formulation comprises…an imager configured to automatically image assay droplets and identify desired droplets…continuously selected multiple desired droplets and deposit them to hit wells” in lines 3-45 because claim 71 depends from instant claim 69, wherein claim 69 already recites what the ‘continuous phase formulation’ comprises and/or how each of the resins or beads is prepared. Additionally, claim 69 does not recite that the system comprises one microdroplet, desired droplets; multiple desired droplets and/or hit wells. Thus, claim 71 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 69 and 71 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Abate et al. (hereinafter “Abate”) (US Patent Application Publication No. 20200261879, published August 20, 2020; effective filing date September 29, 2017).
Regarding claim 69, Abate teaches that monodisperse droplets can be effectively obtained by using monodisperse particles to template the formation of droplets, which can include, e.g., mono-disperse single-emulsion droplets, multiple-emulsion droplets, or Giant Unilamellar Vesicles (GUY), without destroying the integrity of the droplets (Abstract). Abate teaches microfluidic devices used to generate monodisperse template particles for use in the preparation of monodisperse droplets, including, but are not limited to, those described in U.S. Patent Application Publication No. 2015/0232942, the disclosure of which is incorporated by reference herein such as a microfluidic system including a nucleic acid amplification region and a detection region can be used in connection with the processing/incubation and analysis of monodisperse droplets prepared as described herein (paragraph [0025], lines 1-10). Abate teaches that Figure 16 provides a schematic diagram of a workflow to create core-shell microgel using instant emulsion technology, which combines affinity-based PTE with targeted analysis; while Figure 17 provides images of polyacrylamide core beads with an agarose shell (interpreted as core-shell beads and thin-shell beads; a hydrogel encapsulating a core; and hydrophilic agarose grafted onto a core bead, claims 69-71) (paragraphs [0042]-[0043]; and Figures 16 and 17). Figures 16 and 17A are shown below:
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Figure 16
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Figure 17A
Abate teaches that the non-aqueous phase can serve as a carrier fluid forming a continuous phase that is immiscible with water, or the non-aqueous phase can be a dispersed phase. The non-aqueous phase can be referred to as an oil phase including at least one oil, but can include any liquid (or liquefiable) compound or mixture of liquid compounds that is immiscible with water, wherein the oil can be synthetic or naturally occurring, the oil can or may not include carbon and/or silicon, and/or the oil can or may not include hydrogen and/or fluorine, such that a fluorinated oil, such as fluorocarbon oil can be a perfluorinated organic solvent including, but not limited to, HFE7500, FC-40, and perfluoromethyl-decalin (PFMD) (interpreting the fluorinated oils to be continuous phase formulation, fluorous dispersion oil having a fluorine content of about 70 wt % or more, claim 69-71). Abate teaches that a droplet can involve a surfactant stabilized emulsion, e.g., a surfactant stabilized single emulsion or a surfactant stabilized double emulsion, where the surfactant is soluble in the first fluid, second fluid, and/or third fluid, wherein any convenient surfactant that allows for the desired reactions to be performed in the droplets can be used, including, but not limited to, octylphenol ethoxylate (Triton X 100), polyethylene glycol (PEG), C26H50O10 (Tween 20) and/or octylphenoxypolyethoxyethanol (IGEPAL) (interpreted as comprising a droplet stabilizer including a surfactant, claim 69-71) (paragraph [0100]). Abate teaches that the surfactant used depends on a number of factors such as the oil and aqueous phases (or other suitable immiscible phases, e.g., any suitable hydrophobic and hydrophilic phases) used for the emulsions, such that when using aqueous droplets in a fluorocarbon oil, the surfactant can have a hydrophilic block (PEG-PPO) and a hydrophobic fluorinated block (Krytox FSH) (interpreted as a diblock copolymer surfactant stabilizer, claims 69-71) (paragraph [0101]). Abate teaches that exemplary surfactants which can be utilized to provide thermostable emulsions are the "biocompatible" surfactants that include PEG-PFPE (polyethyleneglycol-perflouropolyether) block copolymers, e.g., PEG-Krytox (see, e.g., Holtze et al., "Biocompatible surfactants for water-in-fluorocarbon emulsions," Lab Chip, 2008, 8, 1632-1639, the disclosure of which is incorporated by reference herein), and surfactants that include ionic Krytox in the oil phase and Jeffamine (polyetheramine) in the aqueous phase (see, e.g., DeJournette et al., "Creating Biocompatible Oil-Water Interfaces without Synthesis: Direct Interactions between Primary Amines and Carboxylated Perfluorocarbon Surfactants", Anal. Chem. 2013, 85(21):10556-10564, the disclosure of which is incorporated by reference herein) (interpreting the stabilizer as diblock copolymer surfactants, claims 69-71) (paragraph [0104]). Abate teaches that monodisperse droplets can be sorted using: (a) commercially available flow cytometers such as fluorescence activated cell sorters (FACS) or magnetic activated cell sorting (MACS) devices; (b) size sorters, e.g., a hydrodynamic sorter to recover only larger, single-cell containing drops; (c) passive sorters of interest including hydrodynamic sorters, which sort monodisperse droplets into different channels according to size, based on the different ways in which small and large monodisperse droplets travel though the microfluidic channel; and/or (d) bulk sorters (interpreted as a system comprising a sorter, claims 69-71) (paragraphs [0025]; [0175]; and [0207]-[0208]).
Regarding claim 70 (in part), Abate teaches that droplets can be passed through electrodes or other means of applying an electric field, wherein the electric field can destabilize the droplets such that they are merged together (interpreted as first and second electrodes, claim 70) (paragraph [0113]). Abate teaches that if an electric field is applied to the droplet as it passes the injector, fluid containing the reagents will be injected into the droplet, wherein the amount of reagent added to the droplet can be controlled by several different parameters, such as by adjusting the injection pressure and the velocity of the flowing drops, by switching the electric field on and off, and the like (interpreted as a controller, claim 70) (paragraph [0114]). Abate teaches modulating the voltage to inject different charges for affixed injection volume, the final charge on the monodisperse droplets could be adjusted, to produce monodisperse droplets with a different charge (interpreted as a controller configured to switch electrodes between a first and second state, claim 70) (paragraph [0209], lines 15-19). Abate teaches that the heater includes a Peltier plate, heat sink and control computer (interpreted as a controller, claim 70) (paragraph [0169], lines 1-2). Abate teaches that the monodisperse template particles generation process can be accomplished by pumping two immiscible fluids, such as oil and water into a junction, wherein the junction shape, fluid properties such as viscosity, interfacial tension, etc. and flow rates influence the properties of the monodisperse template particles generated (interpreted as a junction, claim 70) (paragraph [0071], lines 5-11).
Regarding claim 71, Abate teaches that Figure 12 provides images of monodisperse emulsions prepared in a 96 well plate format as discussed in Example 7 (interpreted as a microwell array plate, claim 71) (paragraph [0038]; and Figure 12). Abate teaches that after amplification, the positive monodisperse single-emulsion droplets, multiple-emulsion droplets, and/or GUVs can be sorted into individual compartments, such as well plate arrays, using FACS or MACS, such that the individual compartments can then be subjected to further manipulation (interpreted as a microwell array plate; microdroplets including desired droplets and assay droplets; and interpreting FACS or MACS as an automated-based droplet sampling device, claim 71) (paragraph [0185]). Abate teaches that fluorescence positive droplets were sorted using the FACSAria II from BD and observed under a microscope, such that the sorted beads were fluorescent and were surrounded by agarose shell after FACS (interpreted as comprising a fluorescence microscope; also an imager to identify desired droplets, claim 71) (paragraph [0333]). Abate teaches an EVOS fluorescent microscope for imaging (interpreting the microscope as an imager, claim 71) (paragraph [0356]).
Abate does not specifically exemplify a first and second outlet channel (claim 70, in part).
Abate meets all the limitations of the claims and, therefore, anticipates the claimed invention.
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 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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 69-71are rejected under 35 U.S.C. 103 as being unpatentable over Abate et al. (hereinafter “Abate”) (US Patent Application Publication No. 20200261879, published August 20, 2020; effective filing date September 29, 2017) in view of Cayer et. al. (hereinafter “Cayer”) (US Patent No. 11919000, issued March 5, 2024; filed October 9, 2020; effective filing date October 10, 2019).
The teachings of Abate as applied to claims 69-71 are described supra.
Abate does not specifically exemplify a first and second outlet channel (claim 70, in part).
Regarding claim 70 (in part), Cayer teaches methods and systems for performing high-throughput assays using microfluidic systems including screening large libraries of effector molecules including such methods and systems particularly useful in microfluidic systems (Abstract; and col 1, lines 24-26). Cayer teaches electro-osmosis is believed to produce motion in a stream containing ions, e.g. a liquid such as a buffer, by application of a voltage differential or charge gradient between two or more electrodes (interpreted as two or more electrodes; and configured to apply a differential voltage, claim 70) (col 53, lines 45-49). Cayer teaches the manipulation of individual cells or particles can be accomplished in a streaming fluid, such as in a cell sorter device, using dielectrophoresis, such that using conventional semiconductor technologies, electrodes can be microfabricated onto a substrate to control the force fields in a microfabricated sorting device of the disclosure (interpreted as a first and second electrode configured to cause compositions flowing through a junction, claim 70) (col 54, lines 34-39). Cayer teaches that sorter embodiments of the device also have a discrimination region or branch point in communication with the main channel and with branch channels, and a flow control responsive to the detector, wherein there can be a plurality of detection regions and detectors, working independently or together, e.g., to analyze one or more properties of a sample or encapsulation, such that the branch channels can each lead to an outlet region and to a well or reservoir (interpreted as a plurality of inlets and outlets; and channels meeting at a junction, claim 70) (col 48, lines 7-14). Cayer teaches that there can also be a plurality of inlet regions, each of which introduces droplets of a different sample (e.g., of cells, of virions or of molecules such as molecules of an enzyme or a substrate) into the main channel, wherein each of the one or more inlet regions can also communicate with a well or reservoir (interpreted as a plurality of inlets and outlets, claim 70) (col 48, lines 14-19). Cayer teaches that different switching and flow control mechanisms can be combined on one chip or in one device and can work independently or together as desired (interpreted as a controller, claim 70) (col 54, lines 58-60). Cayer teaches that one detector is an optical detector, such as a microscope, which can be coupled with a computer and/or other image processing or enhancement devices to process images or information produced by the microscope using known techniques, where molecules can be analyzed and/or sorted by size or molecular weight (interpreting the computer as a controller; microscope; and devices as an imager, claims 70 and 71) (col 55, lines 2-7). Cayer teaches that a sorting algorithm can be implemented that is not limited by the intrinsic switching speed of the devices, such that the droplets flow at the highest possible static speed from the inlet channel to the waste channel; and unwanted droplets can be directed into a waste channel at the highest speed possible, such that when the desired molecule, cell or virion is detected, the flow can be slowed down, reversed and/or directed back into the detection region (col 60, lines 20-32). Cayer teaches in Figure 2C, a negative outlet and positive (hit) outlet (interpreted as a first and second outlet channel, claim 71) (col 9, lines 25-27; and Figure 2C).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of performing high-throughput assays using microfluidic systems as exemplified by Cayer, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic systems and methods for generating monodisperse droplets including an amplification region, detection region, and a fluidically connected sorting region as disclosed by Abate to include the microfluidic channels comprising additional inlet and outlet channels as taught by Cayer with a reasonable expectation of success in the efficient on-chip and/or off-chip sorting of scaffolds, molecules, cells and/or virions within monodisperse microfluidic droplets including by flow cytometry such as in a FACS device or MACS device; and/or for efficiently directing unwanted molecules, cells or virions within a microfluidic droplet into a waste channel, and directing desired molecules, cells or virions within a microfluidic droplet back into the detection region at the highest speed possible.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly
rejected under 35 USC §103(a) as obvious over the art.
Conclusion
Claims 69-71 are rejected.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684