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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Response to Amendment
The Amendment filed 10/24/2025 has been entered. Claims 1-5, 10-14, and 16-28 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection, 112(a), and 112(b) rejections previously set forth in the Final Office Action mailed 07/25/2025. New grounds of rejections necessitated by amendments are discussed below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“one or more dilution apparatuses” in claim 1: “apparatuses” is a generic placeholder and has no structural meaning; “apparatuses” is modified by functional language “configured to receive…dilute…eject waste”; “apparatuses” is not modified by sufficient structure, material, or acts for performing the claimed function, e.g. “dilution” does not provide sufficient structure for performing the claimed function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this instant case:
“one or more dilution apparatuses” is interpreted as a chamber or compartment for fluids (paragraph [0036], [0045]; Fig. 1, element 110), microfluidic channels or microfluidic T-mixers (paragraphs [0049]-[0051]; Figs. 10-11), multiplexor chip (paragraph [0053]) or equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 10-14, and 16-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites “the separation device further comprising one or more of a filter, separating fluid inlet, settling channel, magnet, heat source, or light inlet” (emphasis added). While the specification discloses that microcarrier separation devices can include filter based systems (paragraph [0037]), the disclosure fails to describe the separation device further comprising one or more of a separating fluid inlet, settling channel, magnet, heat source, or light inlet. Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-5, 10-14, and 16-28 are rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 103
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 1-2, 4-5, 11-14, 17-25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Link et al. (US 20100137163 A1) in view of Foster et al. (US 20150226657 A1).
Regarding claim 1, Link teaches a system for preparing a biological sample for analysis (abstract teaches microfluidic devices for assays and combinatorial chemistry; paragraph [0009] teaches processing, i.e. preparing, components such as cells, nucleic acids, enzymes, coded microbeads, and other biomaterials; note that “for preparing...for analysis” is interpreted as an intended use of the claimed system, wherein Link’s system is capable of the claimed limitations at a later time), system comprises:
a source of the biological sample (paragraph [0051] teaches a sample solution reservoir or well, i.e. a source of the biological sample, introduces molecules or cells, i.e. biological sample, to the device), wherein the biological sample comprises one or more biological particle(s) suspended in fluid or attached to a microcarrier or other substrate (paragraph [0051] teaches a sample solution reservoir or well that introduces molecules or cells, i.e. biological sample comprising one or more biological particle suspended in fluid, into the device; paragraph [0091] teaches chemical materials can be biological particles, such as tissues, cells, particles, proteins, antibodies, amino acids, nucleotides, small molecules, labels, dyes, or a DNA tag, i.e. biological sample comprising one or more biological particles; paragraph [0207] teaches cells suspended in fluid),
a separation device (Fig. 1, interpreted as the “UV-Release Module”, which includes a channel and reaction zone or releasing means of paragraph [0184], and the “Sorting Module”; Fig. 1 and paragraph [0017] teach the structures are a microfluidic device) configured to perform a separation operation on the one or more biological particle(s) from the biological sample (interpreted as a functional limitation, see MPEP 2114; Fig. 1 shows a “sorting module” that is capable of separating different components into separate channels, i.e. left and right channels; paragraph [0048] teaches a sorting module with branch channels with one or more outlet modules; paragraphs [0149], [0170]-[0171] teach the sorting module is capable of employing a variety of sorting techniques for sorting molecules, cells, small molecules or particles, and thus is capable of separating a biological particle and a microcarrier into separate channels, i.e. perform a separation operation), the separation device comprising an inlet (Fig. 1, interpreted as the inlet of the UV-Release Module and/or the inlet of the Sorting Module) configured to receive reagent to perform the separation operation (interpreted as a functional limitation, see MPEP 2114; the inlet of the UV-Release Module and/or the inlet of the Sorting Module are structurally capable of receiving the claimed reagent at a later time; note that “reagent” is not positively recited structurally), the separation device further comprising one or more of a separating fluid inlet (Fig. 1, interpreted as the inlet of the Sorting Module), settling channel (Fig. 1, interpreted as the channel of the UV-Release Module and/or the channel of the Sorting Module), or light inlet (Fig. 1 shows UV light entering the UV-release module, therefore the structure where the UV light enters is interpreted as a light inlet) configured to separate the one or more biological particle(s) into a channel (interpreted as a functional limitation, see MPEP 2114; Fig. 1 shows a “sorting module” that is capable of separating different components into separate channels, i.e. left and right channels; paragraph [0048] teaches a sorting module with branch channels with one or more outlet modules; paragraphs [0149], [0170]-[0171] teach the sorting module is capable of employing a variety of sorting techniques for sorting molecules, cells, small molecules or particles, and thus is capable of separating a biological particle and a microcarrier into separate channels), wherein the separation device uses at least one of density differences, size exclusion, a fluidic force, an enzymatic reaction, a biological process, a chemical process, an electrical force, a magnetic field, a thermal perturbation, an optical force, a mechanical force, a gravitational force, or combinations thereof (interpreted as an intended use of the separation device, see MPEP 2114; paragraphs [0183] teaches the UV release module is capable of cleaving compounds from beads, i.e. an optical force; paragraph [0184] teaches a releasing means to release chemicals attached to a bead via chemical, UV light, heat, etc.; paragraph [0157] teaches separating can be done isocratic, chemically, electrically, by pressure, or etc.),
an interface (Fig. 1, interpreted as the elements between the UV-Release Module and the detection module) in fluid communication with an analysis instrument (Fig. 1 shows the elements between the UV-Release Module and the detection module are in fluid communication with the detection module, i.e. analysis instrument; paragraph [0148] teaches a detection module in communication with one or more detection apparatuses, and therefore the detection module is interpreted as an analysis instrument), wherein the interface is configured to introduce the one or more biological particle(s) at the desired concentration into the analysis instrument (interpreted as a functional limitation of the claimed interface, MPEP 2114; Fig. 1 shows the elements between the UV-Release Module and the detection module is structurally capable of introducing the at least one biological particle at a desired concentration, e.g. cell sample from the inlet modules, into the detection module, i.e. analysis instrument).
Link fails to teach: one or more dilution apparatuses in fluid communication with the channel of the separation device, the one or more dilution apparatuses configured to receive the one or more biological particle(s) and to receive a solution comprising a diluent, reagent, or both, to dilute the one or more biological particle(s) to a desired concentration, and eject waste.
Link further teaches assembly of modules into complete systems provides a convenient and robust way to construct microfluidic devices (paragraph [0005]), enabling modular integration of systems for transporting and reacting molecules could benefit high throughput screening (paragraph [0304]), channel design can include two dilution channels to prevent surface attachment of cells (paragraph [0073]), and that a sample concentration should be dilute enough to ensure proper measurement (paragraph [0107]).
Foster teaches a system for separating particles suspended in a fluid stream according to their weight, size, or density, the system comprising channels (abstract; Figs. 5-7). Foster teaches one or more dilution apparatuses (Figs. 5-6, particle manipulation systems comprising channels), the one or more dilution apparatuses configured to receive at least one biological particle (Figs. 5-6 shows the system is configured to receive a sample via sample input channel 120 from sample reservoir A; paragraph [0032] teaches the sample fluid comprises cellular particles), receive a solution comprising a diluent, reagent, or both (Figs. 5-6 and paragraphs [0033],[0040],[0054] teach the system receives viscoelastic suspending fluid through channel 121; paragraph [0033] teaches viscoelastic suspending fluid may mix with the sample fluid and dilute it, thus is interpreted as at least a diluent), dilute the at least one biological particle to a desired concentration (Figs. 5-6 and paragraph [0033],[0086] teaches viscoelastic suspending fluid is injected via channel 121 to mix with the sample fluid and dilute it, thus is capable of diluting the sample to a desired concentration), and eject waste (Figs. 5-6 shows pick-off channels 600; paragraph [0061] teaches the pickoff channel may remove a fraction of materials, i.e. eject waste). Foster teaches nontarget materials flow into a waste channel using a movable valve (paragraphs [0054]-[0055]). Foster teaches a dilution apparatus (Figs. 6-7, interpreted as the region and components of viscoelastic region 100) is upstream of an interrogation region (200), which allows for analysis of particles in a sample stream (paragraphs [0047]-[0048]). Foster teaches the arrangement of the system allows for improved speed and effectiveness of the device (paragraph [0067]).
Since Foster teaches a fluidic device for analysis and separation of particles in a fluid stream, similar to Link, 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 system of Link to incorporate Foster’s teachings of one or more dilution apparatuses configured to receive a sample, dilute and mix the sample, and remove fraction of materials (Figs. 5-7; paragraphs [0032]-[0033],[0040],[0054],[0061][0086]) and nontarget materials flowing into a waste channel (paragraphs [0054]-[0055]) and Link’s teachings of enabling modular integration of systems for transporting and reacting molecules could benefit high throughput screening (paragraph [0304]), a channel design can include two dilution channels to prevent surface attachment of cells (paragraph [0073]), and that a sample concentration should be dilute enough to ensure proper measurement (paragraph [0107]) to provide: one or more dilution apparatuses in fluid communication with the channel of the separation device, the one or more dilution apparatuses configured to receive the one or more biological particle(s) and to receive a solution comprising a diluent, reagent, or both, to dilute the one or more biological particle(s) to a desired concentration, and eject waste. Doing so would have a reasonable expectation of successfully improving dilution of a sample to a desired concentration within a fluid stream to ensure proper measurement and improving separation of nontarget materials as discussed by Foster (Figs. 5-6 and paragraph [0033],[0061],[0086]) and preventing surface attachment of cells as discussed by Link (paragraph [0073]).
Note that the limitations of separation device, the one or more dilution apparatuses, and the interface are interpreted as an functional limitations of the claimed system. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114; In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458,459 (CCPA 1963). The system of modified Link is identical to the presently claimed structure as discussed above and therefore, would have the ability to perform the use recited in the claim (see MPEP 2112.01(I)).
Regarding claim 2, Link further teaches wherein the one or more biological particle(s) comprise(s): a cell, cellular fragment, cellular component, virus, bacteria, microbe, pathogen, macromolecule, sugar, genetic material, nucleic acid, DNA, RNA, transcription factor, amino acid, peptide, protein, lipid, enzyme, metabolite, antibody, or receptor (paragraph [0009] teaches processing cells, nucleic acids, enzymes, coded microbeads, and other biomaterials; paragraph [0010] teaches a fluid can comprise tissues, cells, particles, proteins, antibodies, amino acids, nucleotides, small molecules, and pharmaceuticals; paragraph [0051] teaches a sample solution reservoir or well that introduces molecules or cells into the device; paragraph [0091] teaches chemical materials can be biological particles, such as tissues, cells, particles, proteins, antibodies, amino acids, nucleotides, small molecules, labels, dyes, or a DNA tag).
Regarding claim 4, Link further teaches wherein the analysis instrument comprises a laser force analytical instrument (paragraph [0148] teaches the detection module comprising lasers, i.e. laser force analytical instrument), sequencing instrument (in an alternative embodiment, Link, paragraph [0036], teaches the system includes a “sequencing instrument” and “user interface and instrument control”), PCR analysis instrument (paragraph [0176] teaches “flow-through PCR” and paragraph [0148] teaches the detection module comprising detection apparatuses, thus the detection module is capable of analyzing a sample that undergoes flow-through PCR), high performance gas or liquid chromatography (HPLC) (paragraph [0051] teaches “liquid chromatography or HPLC tubing”) or a mass spectrometry (MS) machine (paragraph [0148] teaches the detection module comprising detection apparatuses, and paragraph [0156] teaches “mass spectroscopy”, thus the detection module comprises a mass spectrometry machine or components for mass spectroscopy).
Regarding claim 5, Link further teaches wherein the analysis instrument is configured to measuring velocity, size, eccentricity, or a combination thereof of the one or more one biological particle(s) (paragraph [0148] teaches the detection apparatus comprises lasers, i.e. laser force analytical instrument; paragraph [0086] teaches sorting a sample by size; therefore, the detection apparatus is structurally capable of measuring at least size of at least one biological particle; the analysis instrument is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim, see MPEP 2112.01(I)).
Regarding claim 11, Link further teaches wherein the source of the biological sample is in fluid communication with the analysis instrument (Fig. 1 and paragraph [0051] teaches molecules or cells are introduced into the channel of each analysis unit, therefore the source of the biological sample is in fluid communication with the analysis instrument in order to properly flow into the channels) using pressure or vacuum driven flow, pumping via a peristaltic pump, syringe pump, or diaphragm pump (interpreted as an intended use of the biological sample, see MPEP 2114; Fig. 1 and paragraph [0051] teaches molecules or cells are introduced into the channel of each analysis unit, e.g. and flows to a detection module; paragraph [0089] teaches pressurized syringes; paragraph [0100] teaches pumps to manipulate flow of cells; therefore, syringes and pumps are capable of performing the claimed intended uses of transporting the biological sample using pressure or vacuum at a later time).
Regarding claim 12, Link further teaches wherein a direction of flow is further determined by configurations of one or more control valves and tubing (Fig. 1 and paragraph [0040] teaches sorting in microfluidic devices can be accomplished through the use of mechanical valves and channels, i.e. tubing; paragraph [0112]; paragraph [0053], “tubes”).
Regarding claim 13, Link further wherein the system is configured to receive a plurality of biological samples via a continuous or a batch flow (interpreted as a functional limitation of the system, see MPEP 2114; paragraph [0009], “continuous phase fluid”; paragraph [0090], “fluidic stream may be continuous and/or discontinuous”; paragraph [0100] teaches using drive flow control, thus the system would be capable of receiving samples in a continuous or a batch flow; paragraph [0089] teaches “pressurized syringes”, wherein a syringe can be used at a later time by a user to receive samples in a continuous or batch flow).
Regarding claim 14, modified Link further teaches wherein the source of the biological sample comprises at least one sample-containing vessel (paragraph [0051] teaches a sample solution reservoir or well, therefore the source of the biological sample comprises at last one sample-containing vessel).
Regarding claim 17, modified Link fails to teach wherein the one or more dilution apparatuses, comprises a microfluidic T mixing and dilution device with microfluidic channels.
Link teaches various modules with T-mixing structures (Fig. 1 shows inlet modules, coalescence module, and sorting module with T-shaped junctions). Link teaches channels can communicate with other channels via T-shape or Y-shaped junctions, and other shapes and channel geometries may be used (paragraphs [0084]-[0085]).
Foster teaches a system for separating particles suspended in a fluid stream according to their weight, size, or density, the system comprising channels (abstract; Figs. 5-7). Foster teaches one or more dilution apparatuses (Figs. 5-6, particle manipulation systems comprising channels), the one or more dilution apparatuses configured to receive at least one biological particle (Figs. 5-6 shows the system is configured to receive a sample via sample input channel 120 from sample reservoir A; paragraph [0032] teaches the sample fluid comprises cellular particles), receive a solution comprising a diluent, reagent, or both (Figs. 5-6 and paragraphs [0033],[0040],[0054] teach the system receives viscoelastic suspending fluid through channel 121; paragraph [0033] teaches viscoelastic suspending fluid may mix with the sample fluid and dilute it, thus is interpreted as at least a diluent), dilute the at least one biological particle to a desired concentration (Figs. 5-6 and paragraph [0033],[0086] teaches viscoelastic suspending fluid is injected via channel 121 to mix with the sample fluid and dilute it, thus is capable of diluting the sample to a desired concentration), and eject waste (Figs. 5-6 shows pick-off channels 600; paragraph [0061] teaches the pickoff channel may remove a fraction of materials, i.e. eject waste). Foster teaches nontarget materials flow into a waste channel using a movable valve (paragraphs [0054]-[0055]). Foster teaches a dilution apparatus (Figs. 6-7, interpreted as the region and components of viscoelastic region 100) is upstream of an interrogation region (200), which allows for analysis of particles in a sample stream (paragraphs [0047]-[0048]). Foster teaches the arrangement of the system allows for improved speed and effectiveness of the device (paragraph [0067]).
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 system of Link to incorporate Foster’s teachings of one or more dilution apparatuses configured to receive a sample, dilute and mix the sample, and remove fraction of materials (Figs. 5-7; paragraphs [0032]-[0033],[0040],[0054],[0061][0086]) and nontarget materials flowing into a waste channel (paragraphs [0054]-[0055]) and Link’s teachings of channels can communicating with other channels via T-shape or Y-shaped junctions, and other shapes and channel geometries may be used (paragraphs [0084]-[0085]).to provide: wherein the one or more dilution apparatuses, comprises a microfluidic T mixing and dilution device with microfluidic channels. Doing so would have utilized known T-shape configurations to communicate channels with a reasonable expectation of successfully improving dilution of a sample to a desired concentration within a fluid stream to ensure proper measurement and improving separation of nontarget materials as discussed by Foster (Figs. 5-6 and paragraph [0033],[0061],[0086]).
Regarding claim 18, Link further teaches wherein the microfluidic T-mixing and dilution device comprises a base T, offset T, T's in parallel, T's with multiple discrete inputs, T's with multiplex inputs that combine into one, or a combination thereof (Fig. 1 shows the interface, i.e. the elements between the UV-Release Module and the detection module, comprises a T structure at the coalescence module; Fig. 1 shows the coalescence module having a T structure with multiplex inputs; paragraph [0040] teaches “T-junction bifurcation”).
Regarding claim 19, Link further teaches the system further comprising a sampling manifold chip or cup (Fig. 1 and paragraph [0041], interpreted as the inlet modules, collection module outlet channel, or a waste module channel; paragraphs [0079], [0185],[0186] teach the system can include a receptacle, cuvette, or container, i.e. cup) and an interface to an autosampler (Fig. 1, interpreted as the inlet modules, collection module outlet channel, or waste module channel which is capable of interfacing with an autosampler; paragraph [0083] teaches a channel is connected to a means for collection a sample from said device).
Note that the autosampler is not positively recited structurally and is interpreted as an intended use of the claimed system. The inlet modules, collection module, waste module are capable of interfacing with an autosampler at a later time since they have inlet/outlet channels.
Regarding claim 20, Link further teaches wherein the separation device comprises a horizontal channel for gravitational separation (Link, Fig. 1 shows horizontal channels of the sorting module, collection module and waste module, wherein the microcarrier and particle can be separated gravitationally at a later time, e.g. by a user; paragraph [0219] teaches a delay line that can depend on gravity).
Regarding claim 21, Link further wherein teaches the separation device is configured to use density differences to separate fluids of varying density (Fig. 1 shows horizontal channels of the sorting module, the collection module and waste module, wherein the microcarrier and particle can be separated using fluids of varying density at a later time via the channels; paragraph [0113] teaches fluids of different densities are advantageous for sorting).
Regarding claim 22, Link further teaches wherein the separation device is configured to use an active force in a vertical channel to perform a separation (Fig. 1 shows a detection module in a vertical channel and a sorting module comprising a vertical channel, wherein paragraph [0222] teaches using dielectrophoretic and electrostrictive forces based on a fluorescence probe; thus, an active force is implied to be at least used in the vertical channels to properly sort; paragraph [0157] teaches separating can be done isocratic, chemically, electrically, by pressure, or etc.; note that a user is capable of providing an active force in the vertical channel at a later time for separation).
Regarding claim 23, Link further teaches wherein the separation device is configured to use an active force in a horizontal channel to perform a separation (Fig. 1 a sorting module comprising a horizontal channel, wherein paragraph [0222] teaches using dielectrophoretic and electrostrictive forces based on a fluorescence probe; thus, an active force is implied to be at least used in the horizontal channels to properly sort; paragraph [0157] teaches separating can be done isocratic, chemically, electrically, by pressure, or etc.; note that a user is capable of providing an active force in the horizontal channel at a later time for separation).
Regarding claim 24, Link further teaches wherein the separation device comprises an angled mesh, pillars, or other structures configured to perform a size-based separation (paragraph [0157] teaches a separating means could include size; paragraph [0158] teaches a detector, wherein molecules can be sorted by size; wherein “separating means” or “detector” are interpreted as “other structures”; paragraphs [0100] and [0170] teaches valves and pumps to manipulate the flow of molecules in one or more directions, wherein valves and/or pumps are interpreted as “other structures”; furthermore, the biological sample can be separated using the “other structures” of Link at a later time), wherein flow within the separation device is continuous or pulsatile (paragraph [0009], “continuous phase fluid”; paragraph [0090], “fluidic stream may be continuous and/or discontinuous”).
Regarding claim 25, Link further teaches the separation device is configured to use inertial fluidic forces to perform a size-based separation (paragraph [0087] teaches application of any force may be used to provide a flow to provide for sorting, such as pressure, i.e. inertial fluidic forces).
Regarding claim 27, Link further teaches wherein the separation device is configured to use: i) inertial fluidic forces; and ii) optical forces, electrical forces, or optical and electrical forces to perform a separation (paragraph [0041] teaches the substrate can comprise one or more sorting modules; paragraphs [0170]-[0171] teaches dielectric, electric, electro-osmotic, (micro-) valve, etc. to change or direct the flow of molecules, cells, small molecules or particles into a predetermined branch channel; paragraph [0157] teaches separating can be done isocratic, chemically, electrically, by pressure, or etc.; paragraph [0114] teaches changing flow path can be accomplished by mechanical, electrical, optical, or other technique; paragraph [0087] teaches application of any force may be used to provide a flow to provide for sorting, such as pressure; thus, the device is capable of sorting a microcarrier from biological particle based on size at a later time using inertial fluidic forces, e.g. pressure from fluid flow, and optical or electrical forces; paragraph [0170] further teaches “additional sorting”).
Regarding claim 28, Link further teaches wherein the one or more biological particle(s) comprises a cell (paragraph [0009] teaches processing components such as cells; paragraph [0010] teaches chemical material includes cells; paragraph [0051]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Foster as applied to claim 1 above, and further in view of Hart et al. (US 20170227442 A1).
Regarding claim 3, while Link teaches a sample solution reservoir or well (paragraph [0051]) and an embodiment of multiple samples each separately contained within sample wells connected to one or more inlet channels (paragraph [0300]), modified Link fails to explicitly teach wherein the source of the biological sample comprises one or more of a bioreactor, flask, bottle, test tube, slide, bag, microtiter plate, microtiter dish, multi-well plate, culture dish, permeable support, or combinations thereof.
Hart teaches a device for particle separation for fluids (paragraph [0003]), such as for biological species such as cells, bacteria, and viruses (paragraph [0015]). Hart teaches a system (Fig. 12) comprising multiwell plates (580, 590) and multiple bioreactors, flasks, bottles, or test tubes (reservoirs 200), wherein a microfluidic chip (400) is attached to a number of fluid connections that include sample inlets to the well plate samples and sample vessels (Fig. 12; paragraph [0058]). Hart teaches a sample inlet contains one or more well plate samples, and a sample vessel could be a microfluidic well plate that contains an array of samples in different reservoirs (paragraph [0058]).
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 vessel of modified Link to incorporate the teachings of multiple well plate samples and sample vessels of Hart (Fig. 12; paragraph [0058]) and the teachings of multiple samples contained in sample wells of Link (paragraph [0300]) to provide: wherein the source of the biological sample comprises one or more of a bioreactor, flask, bottle, test tube, slide, bag, microtiter plate, microtiter dish, multi-well plate, culture dish, permeable support, or combinations thereof. Doing so would have a reasonable expectation of successfully improving throughput of the overall system by allowing for multiple samples to be present and used in the system via known types of vessels for containing samples as taught by Hart.
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Foster as applied to claim 1 above, and further in view of Yamaguchi et al. (US 20020071119 A1).
Regarding claim 10, Link further teaches the system of claim 1, further comprising one or more control valves (paragraph [0040], “mechanical valves”; paragraph [0089], “valve…to control the flow…”; paragraph [0100], “valves”).
While Link teaches on-off values to direct particles (paragraph [0105]), washing a cell suspension (paragraphs [0320], [0331]), and flowing reagents in channels of a microfluidic device (paragraph [0100]), modified Link fails to teach: wherein the one or more control valves comprise a first 3-way valve open to a decontamination fluid and closed to the source of the biological sample and a second 3-way valve closed to the solution and open to the decontamination fluid, wherein the decontamination fluid is configured to flow through the one or more dilution apparatuses.
Yamaguchi teaches an apparatus in which a sample circulation circulates and allowing the flow cell to be washed easily and surely (abstract; Fig. 1). Yamaguchi teaches one or more control valves (Fig. 1, three-way electromagnetic valves 6a and 6c) comprise a first 3-way valve (6a) and a second 3 way valve (6c). Yamaguchi teaches the first 3-way valve (6a) is coupled to a decontamination fluid (Fig. 1 and paragraph [0043] teach injection path 6b is coupled to and comprises washing liquid from washer liquid supplying path 6d) and a sample-containing vessel (paragraph [0045] teach sample solution is supplied from supplying part 3). Yamaguchi teaches the second 3 way valve (6c) is coupled to the decontamination liquid (Fig. 1 shows element 6c coupled to a washer liquid) and coupled to a solution (Fig. 1 shows element 6c coupled to a dilution solvent). Yamaguchi teaches a first step of supplying a sample solution from supply part 3 into flow path 1 (paragraph [0045]) and after measurement is complete, a wash liquid is injected from part 6 into flow path 1 to circulate through the flow path 1 (paragraph [0051]). Yamaguchi teaches it is possible to inject disjunctively the washer liquid or the dilution liquid into the flow path 1 by switching the three-way electromagnetic valves 6a, 6c (i.e. first and second 3 way valve) appropriately (paragraph [0044]).
Since Yamaguchi teaches a fluidic device for flowing particles for analysis, similar to modified Link, 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 one or more control valve of modified Link to incorporate the teachings of 3 way valves and washer/dilution liquid of Yamaguchi (Fig. 1; paragraphs [0044]-[0045]) to provide: wherein the one or more control valves comprise a first 3-way valve open to a decontamination fluid and closed to the source of the biological sample and a second 3-way valve closed to the solution and open to the decontamination fluid, wherein the decontamination fluid is configured to flow through the one or more dilution apparatuses. Doing so would have a reasonable expectation of successfully ensuring proper fluid connections and improved control of desired fluids into the system to allow the system to be washed easily and surely as taught by Yamaguchi.
Regarding claim 16, Link further teaches the system further comprising a process control system in communication with at least one of the source of the biological sample, separation device, one or more dilution apparatuses, interface, analysis instrument, one or more control valves, or combination thereof (paragraph [0159] teaches a computer that controls valve action, therefore the system comprises a process control system in communication with at least one or more control valves; paragraph [0148] teaches the detection modules comprises processors to detect a signal and direct measurement or sorting, thus is a process control system in communication with at least the analysis instrument; paragraph [0170] teaches the sorting is under control of a detection module).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Foster and Hart as applied to claim 14 above, and further in view of Zohar et al. (US 20170355950 A1).
Regarding claim 26, Link further teaches the system of claim 14, further comprising a sample extraction apparatus comprising a dip tube (paragraphs [0077] and [0089] teaches a syringe; paragraph [0089] teaches a main and sample inlet channel, pressurized syringes feeding into the inlet channels, wherein the “syringe” is interpreted as a “dip tube”, since a syringe structurally implies a tube that can be dipped) for extracting the biological sample from the sample-containing vessel (interpreted as an intended use of the dip tube, see MPEP 2114; paragraph [0051] teaches a sample solution reservoir or well, i.e. a vessel, for introducing a sample to the device, and positive pressure allows for introduction of a sample from a reservoir to the inlet module; paragraphs [0077] teaches a solution can be injected via a syringe and [0089] teaches a syringe to feed channels, therefore the syringe is structurally capable of extracting a biological sample from a sample-containing vessel at a later time), wherein the sample extraction apparatus is configured to obtain a plurality of biological samples from the plurality of vessels (paragraph [0089] teaches a main and sample inlet channel, pressurized syringes feeding into the inlet channels, wherein the pressurized syringes are capable of extracting from the plurality of vessels at a later time; claim 39 recites loading multiple samples on to the device).
Modified Link fails to explicitly teach the dip tube is a sterile dip tube.
Zohar teaches systems for dissociating biological tissues into viable cells (abstract), wherein an entire microfluidic system (including tubing, syringes, and adapters) is sterilized to prevent microbial contamination (e.g., prior to tissue sample loading) (paragraph [0087]).
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 dip tube of modified Link to incorporate the teachings of sterilization of Zohar to provide the dip tube of Link as a sterile dip tube. Doing so would prevent contamination of the system during sample processing.
Note that the limitation of “configured to obtain…” is interpreted as a functional limitation of the claimed sample extraction apparatus. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The system of modified Link is identical to the presently claimed structure. Link teaches “sample extraction apparatus” and therefore, would have the ability to perform the function recited in the claim. See MPEP 2112.01. As discussed above, Link’s “sample extraction apparatus” is capable of extracting a biological sample from a plurality of vessels at a later time since structures such as a pressurized syringe and pump are capable of extracting a sample at a later time.
In an alternative interpretation, claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Foster as applied to claim 25 above, and further in view of Kapur et al. (US 20160123858 A1).
Regarding claim 27, if it is determined that modified Link fails to teach wherein the separation device is configured to use: i) inertial fluidic forces and ii) optical forces, electrical forces, or optical and electrical forces, to perform a separation, Kapur teaches that other functionality may be added to the microfluidic system to enhance the focusing, concentrating, separating, and/or mixing of particles; for instance, additional forces may be introduced which result in target specific modification of particle flow, wherein the additional force may include, for example, magnetic forces, acoustic forces, gravitational/centrifugal forces, electrical forces, and/or inertial forces (paragraph [0164]).
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 system of modified Link to incorporate the teachings of using additional forces to manipulating particles of Kapur to provide wherein the separation device is configured to use: i) inertial fluidic forces and ii) optical forces, electrical forces, or optical and electrical forces, to perform a separation. Doing so would improve focusing, concentrating, separating, and/or mixing of particles as taught by Kapur (paragraph [0164]).
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 10/24/2025, with respect to the drawing objections, claim objections, and rejections under 35 U.S.C. 112(a) and 112(b) have been fully considered and are persuasive. The drawing objections, claim objections, and rejections under 35 U.S.C. 112(a) and 112(b) of 07/25/2025 have been withdrawn.
Applicant's arguments, see pages 8-9, with respect to the claim interpretations under 35 U.S.C. 112(f) have been fully considered but they are not fully persuasive.
In response to applicant’s argument that the claims have been amended to recite sufficient structure to withdraw the “means-plus-function” interpretations of “separation device”, the examiner agrees. Therefore, the interpretation of “separation device” under 112(f) is withdrawn. Regarding applicant’s argument regarding “one or more dilution apparatuses”, the examiner disagrees.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“one or more dilution apparatuses” in claim 1: “apparatuses” is a generic placeholder and has no structural meaning; “apparatuses” is modified by functional language “configured to receive…dilute…eject waste”; “apparatuses” is not modified by sufficient structure, material, or acts for performing the claimed function, e.g. “dilution” does not provide sufficient structure for performing the claimed function.
The amended claim 1 does not provide sufficient structures to the “dilution apparatuses” to avoid interpretations under 112(f).
Applicant’s arguments, see pages 10-19, filed 10/24/2025, with respect to the rejections of claims 1-2, 4-5, 9, 11-13, 16-25, and 27-28 under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive.
In response to applicant’s argument that Link fails to teach “an interface in fluid communication with an analysis instrument , wherein the interface is configured to introduce the one or more biological particle(s) at the desired concentration into the analysis instrument” (Remarks, pages 14 and 17), the examiner disagrees. Link teaches: an interface (Fig. 1, interpreted as the elements between the UV-Release Module and the detection module) in fluid communication with an analysis instrument (Fig. 1 shows the elements between the UV-Release Module and the detection module are in fluid communication with the detection module, i.e. analysis instrument; paragraph [0148] teaches a detection module in communication with one or more detection apparatuses, and therefore the detection module is interpreted as an analysis instrument), wherein the interface is configured to introduce the one or more biological particle(s) at the desired concentration into the analysis instrument (interpreted as a functional limitation of the claimed interface, MPEP 2114; Fig. 1 shows the elements between the UV-Release Module and the detection module is structurally capable of introducing the at least one biological particle at a desired concentration, e.g. cell sample from the inlet modules, into the detection module, i.e. analysis instrument). Note that the limitations of the interface are interpreted as an functional limitations of the claimed system. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114; In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458,459 (CCPA 1963). The system of modified Link is identical to the presently claimed structure as discussed above and therefore, would have the ability to perform the function of the interface recited in the claim (see MPEP 2112.01(I)).
In response to applicant’s argument that Link fails to teach “a separation device further comprising one or more of a filter, separating fluid inlet, settling channel, magnet, heat source, or light inlet configured to separate the one or more biological particle(s) into a channel, wherein the separation device uses at least one of density differences, size exclusion, a fluidic force, an enzymatic reaction, a biological process, a chemical process, an electrical force, a magnetic field, a thermal perturbation, an optical force, a mechanical force, a gravitational force, or combinations thereof” (Remarks, page 14), the examiner disagrees. Link teaches: the separation device further comprising one or more of a separating fluid inlet (Fig. 1, interpreted as the inlet of the Sorting Module), settling channel (Fig. 1, interpreted as the channel of the UV-Release Module and/or the channel of the Sorting Module), or light inlet (Fig. 1 shows UV light entering the UV-release module, therefore the structure where the UV light enters is interpreted as a light inlet) configured to separate the one or more biological particle(s) into a channel (interpreted as a functional limitation, see MPEP 2114; Fig. 1 shows a “sorting module” that is capable of separating different components into separate channels, i.e. left and right channels; paragraph [0048] teaches a sorting module with branch channels with one or more outlet modules; paragraphs [0149], [0170]-[0171] teach the sorting module is capable of employing a variety of sorting techniques for sorting molecules, cells, small molecules or particles, and thus is capable of separating a biological particle and a microcarrier into separate channels), wherein the separation device uses at least one of density differences, size exclusion, a fluidic force, an enzymatic reaction, a biological process, a chemical process, an electrical force, a magnetic field, a thermal perturbation, an optical force, a mechanical force, a gravitational force, or combinations thereof (interpreted as an intended use of the separation device, see MPEP 2114; paragraphs [0183] teaches the UV release module is capable of cleaving compounds from beads, i.e. an optical force; paragraph [0184] teaches a releasing means to release chemicals attached to a bead via chemical, UV light, heat, etc.; paragraph [0157] teaches separating can be done isocratic, chemically, electrically, by pressure, or etc.). Note that the limitations of separation device are interpreted as an functional limitations of the claimed system. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114; In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458,459 (CCPA 1963). The system of modified Link is identical to the presently claimed structure as discussed above and therefore, would have the ability to perform the functions of the separation device recited in the claim (see MPEP 2112.01(I)).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references to arrive at the claimed “one or more dilution apparatuses” since the combination would fail to achieve the system as claimed (Remarks, pages 14-18), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Link provides teachings and motivation of enabling modular integration of systems for transporting and reacting molecules could benefit high throughput screening (paragraph [0304]), and a channel design can include two dilution channels to prevent surface attachment of cells (paragraph [0073]). Foster provides teachings of one or more dilution apparatuses configured to receive a sample, dilute and mix the sample, and remove fraction of materials (Figs. 5-7; paragraphs [0032]-[0033],[0040],[0054],[0061][0086]) and nontarget materials flowing into a waste channel (paragraphs [0054]-[0055]). Foster also provides motivation of diluting a particle to a desired concentration (Figs. 5-6 and paragraph [0033],[0086] teaches viscoelastic suspending fluid is injected via channel 121 to mix with the sample fluid and dilute it) which allows for analysis of particles in a sample stream (paragraphs [0047]-[0048]).
Since Foster teaches a fluidic device for analysis and separation of particles in a fluid stream, similar to Link, it would have been obvious to one of ordinary skill in the art to have modified the system of Link to incorporate Foster’s teachings of one or more dilution apparatuses configured to receive a sample, dilute and mix the sample, and remove fraction of materials (Figs. 5-7; paragraphs [0032]-[0033],[0040],[0054],[0061][0086]) and nontarget materials flowing into a waste channel (paragraphs [0054]-[0055]) and Link’s teachings of enabling modular integration of systems for transporting and reacting molecules could benefit high throughput screening (paragraph [0304]), a channel design can include two dilution channels to prevent surface attachment of cells (paragraph [0073]), and that a sample concentration should be dilute enough to ensure proper measurement (paragraph [0107]) to provide: one or more dilution apparatuses in fluid communication with the channel of the separation device, the one or more dilution apparatuses configured to receive the one or more biological particle(s) and to receive a solution comprising a diluent, reagent, or both, to dilute the one or more biological particle(s) to a desired concentration, and eject waste. Doing so would have a reasonable expectation of successfully improving dilution of a sample to a desired concentration within a fluid stream to ensure proper measurement and improving separation of nontarget materials as discussed by Foster (Figs. 5-6 and paragraph [0033],[0061],[0086]) and preventing surface attachment of cells as discussed by Link (paragraph [0073]).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed system including the claimed one or more dilution apparatus.
In regards to applicant’s arguments regarding claims 3, 10, 14, 26, and 27 (Remarks, pages 18-19), the examiner disagrees for the same reasons as discussed above regarding claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Spaid et al. (US 20030041652 A1) teaches microfluidic devices (abstract). Spaid teaches a multiplexor chip (Fig. 39, interpreted as a chip comprising multiple channels, such as multiple input channels) comprising a T-junction (Fig. 39), wherein the T-junction and applied pressures of wells allows for a dilution ratio (paragraph [0203]).
Obara (US 20150212105 A1) teaches an analysis system in which droplets in a microfluidic device are transported to an analysis apparatus (abstract). Obara teaches the substrate solution and the diluted solution are respectively injected via the inlet 2211 and 2212, and are confluent with each other at a T-junction 2216, and are mixed together (paragraph [0123]).
Makarewicz et al. (US 20140200164 A1) teaches systems for detection of droplets (abstract). Makarewicz teaches the system includes spacers that include one dilution inlet channel and is T-shaped (paragraph [0196]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758