DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Summary
This action is responsive to the Request for Continued Examination filed on 03/02/2026. The amendment has been entered. Applicant has submitted Claims 1-21 for examination. Applicant's amendments to the Claims have overcome each and every objection and 112 rejection previously set forth in the Non-Final Office Action mailed 12/02/2025.
Examiner finds the following: 1) Claims 1-21 are rejected; 2) no claims are objected to; and 3) no claims allowable.
Response to Arguments and Remarks
Examiner respectfully acknowledges Applicant's remarks.
Regarding the remarks about use of Knollenberg, Examiner is not persuaded.
First, Applicant argues that combining Thaker and Knollengberg would change the principle operation of Thaker.
By and large, the main operations of the claimed invention are mapped to Thaker. Examiner relies on Knollenberg for a dynamic scattering assembly and an explicit teaching of a processor, and upon Simpson for an explicit teaching of fiber optics. Examiner generally understands the principles of scattering, processors, and fiber optics to be well known in the art, and would reasonable understand that PHOSITA would know how to incorporate and adapt such principles into Thaker. Thus, Examiner maintains the combination and rejection.
Second, Applicant argues that Knollenberg is not analogous art, specifically that Knollenberg is not from the same field of endeavor.
In response to Applicant's argument, it has been held that a prior art reference must either be in the field of the inventor's endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention (See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992)).
In this case, as previously noted, Thaker discloses a microfluidic device as the primary reference. The slurry system of Knollenberg is, in many ways, operationally similar to Thaker. It uses a dynamic light scattering probe to monitor the liquid as it moves through the fluid chamber. Examiner does not feel that applying the principles of one system to another, similar system, to be unreasonable. In fact, pursuant to MPEP 2141(a)(I) (emphasis added):
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007))
Examiner understands it to be reasonable that PHOSITA would be able to look at Thaker and Knollenberg, similar systems in principle, and be able to take the teaching of one to improve the other. To better articulate to Applicant why PHOSITA would be motivated to do so, it is as simple as adapting the monitoring of Knollenberg, which tracks multiple aspects of the fluid, into the microfluid device of Thaker, in which fine monitoring could be valuable, depending on the needs of the user. Thus, Examiner maintains the combination and rejection.
Third, Applicant argues that Knollenberg is not reasonably pertinent to the problem addressed in the application.
In the name of brevity, Examiner directs Applicant to the above section regarding non-analogous art and how the fine monitoring are principles taught by Thaker. Thus, Examiner maintains the combination and rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 16-18 and 20 are rejected under 35 USC § 103 as obvious in view of Thaker (US 20210272654 A1) and in further view of Knollenberg (US 20200158616 A1).
Regarding Claim 16, Thaker discloses:
A method comprising:
(a) communicating fluid components (Thacker, FIG. 3F, [00432], first fluidic medium 180) through a fluid mixing assembly of a process chip (Thaker, FIG. 3B, [0419], microfluidic device 200) to generate a mixture including encapsulated particles in a fluid (Thaker, FIG. 3F, [0432], “a first fluidic medium 180 in the microfluidic channel 122A may mix with a second fluidic medium 248 in the isolation region 240 substantially by diffusion of components of the first medium 180 from the microfluidic channel 122A through the connection region 236 and into the second fluidic medium 248 in the isolation region 240”); …
Thaker discloses the above but does not explicitly disclose:
… (b) monitoring a pressure of the fluid components communicated through the mixing assembly;
(c) activating a dynamic light scattering assembly to determine a size or size distribution of the encapsulated particles in the fluid, the dynamic light scattering assembly scattering light off the particles while the fluid is in the process chip; and
(d) correlating the monitored pressure of the fluid components with the determined particle size or size distribution.
However, Knollenberg, in a similar field of endeavor (Slurry Monitor Coupling Bulk Size Distribution And Single Particle Detection), discloses:
… (b) monitoring a pressure of the fluid components communicated through the mixing assembly (Knollenberg, FIG. 1, [0062], “the systems and methods disclosed herein include a first probe and a second probe, each probe independently selected from the group consisting of … a pressure probe…”);
(c) activating a dynamic light scattering assembly to determine a size or size distribution of the encapsulated particles in the fluid, the dynamic light scattering assembly scattering light off the particles while the fluid is in the process chip (Knollenberg, Example 4, [0084], “a particle detection system comprises a first probe that is a dynamic light scattering probe configured or optimized for determining a concentration and/or size distribution of a plurality of small particles in a liquid sample”); and
(d) correlating the monitored pressure of the fluid components with the determined particle size or size distribution (Knollenberg, [0047], “The term “probe” refers to a system capable of detecting particles suspended and/or dispersed in a fluid, a system capable of determining the sizes of particles suspended and/or dispersed in a fluid, system capable of counting particles suspended and/or dispersed in a fluid, system capable of classification of particles suspended and/or dispersed in a fluid, or any combination of these.” Examiner notes that FIG. 1, [0062], “the systems and methods disclosed herein include a first probe and a second probe, each probe independently selected from the group consisting of … a pressure probe…” shows that Knollenberg teaches that determining the sizes of particles and counting particles with a pressure probe, which would inherently correlate the two).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Thaker with the dynamic light scattering of Knollenberg. PHOSITA would have known about the uses of dynamic light scattering as disclosed by Knollenberg and how to use them to modify Thaker. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of dynamic light scattering on microdevice chambers.
Regarding Claim 17, the combination of Thaker and Knollenberg discloses Claim 16, and Knollenberg further discloses:
… further comprising adjusting the communication of fluid components through the mixing assembly using at least the monitored pressure (Knollenberg, FIG. 1, [0069], “Particle detection system 100 may controllably change the flow rate of sample 008 through sample chamber 106, for example via a pump such as pump 102(I) and/or 102(II). The flow rate may be dynamically varied during characterization of sample 008.” Examiner notes that flow rate is inherently intertwined with pressure due to Bernoulli's Principle and Hagen–Poiseuille equation).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker and Knollenberg with the flow rate monitoring of Knollenberg. PHOSITA would have known about the uses of flow rate monitoring as disclosed by Knollenberg and how to use them to modify the combination of Thaker and Knollenberg. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of flow rate monitoring to adjust the characteristics of the sample.
Regarding Claim 18, the combination of Thaker and Knollenberg discloses Claim 16 and Thaker further discloses:
… further comprising determining that a monitored pressure falls outside a predetermined range, the activating the dynamic light scattering assembly being performed in response to the determination that a monitored pressure falls outside a predetermined range (Thaker, [0378], the one or more artificial intelligence modules 123 may identify segments of the associated data with metrics that exceed or fall below a certain threshold (e.g., a confidence level exceeding a first threshold, an estimated error below a second threshold, etc.) as a part of a training or benchmark dataset for training one or more models to improve the accuracy in their predictions of these one or more models).
Additionally, Knollenberg further discloses in FIG. 1, [0069]:
the flow rate may be increased to improve range and/or accuracy of the particle size distribution and concentration measurement corresponding to the second particles or the flow may be decreased to improve detection range and/or accuracy of the particle size distribution and concentration measurement corresponding to the first particles. (Examiner notes that flow rate is inherently intertwined with pressure due to Bernoulli's Principle Hagen–Poiseuille equation)
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker and Knollenberg with the threshold monitoring and flow rate monitoring of Knollenberg. PHOSITA would have known about the uses of threshold monitoring and flow rate monitoring as disclosed by Knollenberg and how to use them to modify the combination of Thaker and Knollenberg. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of threshold monitoring and flow rate monitoring to adjust the characteristics of the sample.
Regarding Claim 20, Thaker discloses:
An apparatus comprising:
a process chip (Thaker, FIG. 3B, [0419], microfluidic device 200), the process chip including: …
… a processor, the processor being configured to activate the [fluid components] of the plurality of mixing assemblies (Thaker, FIG. 3O, [0399], “Computer system 300O may transmit and receive messages, data, and instructions, including program (e.g., application code) through communication link 315O and communication interface 314O.” Examiner notes that for computer system 300O to execute the sequence of instructions to practice Thaker, computer system 300O would inherently control the valves to control the fluid flow) …
Though Thaker discloses the above and components such as fluid input ([0424]), valves ([0369]), and pumps ([0369]), Thaker does not explicitly disclose the following as clearly as Examiner would want for claim mapping purposes:
… a first fluid input port,
a first fluid input manifold fluidically coupled with the first fluid input port,
a second fluid input port,
a second fluid input manifold fluidically coupled with the second fluid input port,
a plurality of mixing assemblies, each mixing assembly including:
a first valve fluidically coupled with the first input manifold,
a first inlet fluidically coupled with the first valve,
a second valve fluidically coupled with the second input manifold,
a second inlet fluidically coupled with the second valve, and
an outlet, the mixing assembly being configured to form a mixture of fluids from the first and second inlets and communicate the mixture out through the outlet; …
one or more measurement features, the one or more measurement features being operable to detect one or more characteristics of the mixture; and …
… based on data from the one or more measurement features.
However, Knollenberg, in a similar field of endeavor (Slurry Monitor Coupling Bulk Size Distribution And Single Particle Detection), discloses:
… a first fluid input port (Knollenberg, FIG. 1, [0068], “Pump 102(I) is in fluid communication with conduits 101(I) and 101(II) and forces flow of a liquid sample 008 of slurry 004 from slurry source 002 to sample chamber 106”),
a first fluid input manifold fluidically coupled with the first fluid input port (Knollenberg, FIG. 1, [0068], conduit 101(II)),
a second fluid input port (Knollenberg, FIG. 1, [0070], “sample chamber 106 is flushed via fluid conduit(s) 101(VIII)”),
a second fluid input manifold fluidically coupled with the second fluid input port (Knollenberg, FIG. 1, [0068], conduit 101(VIII)),
a plurality of mixing assemblies, each mixing assembly including:
a first valve fluidically coupled with the first input manifold (Knollenberg, [0053], “The flow rate may be controlled by any means known in the art, including by flow controllers, pumps, vacuum sources, valves, solenoids and the like that are fluidically integrated to any of the devices or methods described herein,” and FIG. 1, [0072], “The varying of flow rates may be accomplished by control of one or more pumps 102(I)-102(IV) and/or by various flow control elements such as valves, switches and/or flow-controllers”),
a first inlet fluidically coupled with the first valve (Knollenberg, FIG. 1, [0068], “Pump 102(I) is in fluid communication with conduits 101(I) and 101(II) and forces flow of a liquid sample 008 of slurry 004 from slurry source 002 to sample chamber 106”),
a second valve fluidically coupled with the second input manifold (Knollenberg, [0053], “The flow rate may be controlled by any means known in the art, including by flow controllers, pumps, vacuum sources, valves, solenoids and the like that are fluidically integrated to any of the devices or methods described herein,” and FIG. 1, [0072], “The varying of flow rates may be accomplished by control of one or more pumps 102(I)-102(IV) and/or by various flow control elements such as valves, switches and/or flow-controllers”),
a second inlet fluidically coupled with the second valve (Knollenberg, FIG. 1, [0070], “sample chamber 106 is flushed via fluid conduit(s) 101(VIII)”), and
an outlet, the mixing assembly being configured to form a mixture of fluids from the first and second inlets and communicate the mixture out through the outlet (Knollenberg, FIG. 1, [0068], “Liquid sample 008 flows out of chamber 106 via fluid conduit, such as conduit(s) 101(III) and/or 101(IV)”); …
one or more measurement features, the one or more measurement features being operable to detect one or more characteristics of the mixture (Knollenberg, FIG. 1, [0068], first and second probes 110 and 120); and …
… based on data from the one or more measurement features (Knollenberg, FIG. 1, [0069], “Particle detection system 100 may controllably change the flow rate of sample 008 through sample chamber 106, for example via a pump such as pump 102(I) and/or 102(II). The flow rate may be dynamically varied during characterization of sample 008”).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Thaker with the dynamic light scattering of Knollenberg. PHOSITA would have known about the uses of dynamic light scattering as disclosed by Knollenberg and how to use them to modify Thaker. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of dynamic light scattering on microdevice chambers.
Claim 1-15, 19, and 21 are rejected under 35 USC § 103 as obvious in view of Thaker (US 20210272654 A1), in view of Knollenberg (US 20200158616 A1), and in further view of Simpson (US 20210237078 A1).
Regarding Claim 1, Thaker discloses:
An apparatus comprising:
(a) a process chip (Thaker, FIG. 3B, [0419], microfluidic device 200), the process chip including:
(i) a fluid chamber (Thaker, FIG. 3B, [0419], region/chamber 202), the fluid chamber including a fluid chamber inlet and a fluid chamber outlet (Thaker, [0309], “A microfluidic device … may include an instrument that manipulates (e.g., by using active and/or passive components and/or micro-components such as micropumps, microvalves, etc.), and [0689], “The one or more flow channels may then be flushed to remove the assay reagent.” Examiner notes that for Thaker to flush the chamber that it would inherently use an inlet and an outlet), and
(ii) an optically transmissive material adjacent to the fluid chamber (Thaker, FIG. 3B, [0420], “changing patterns of light 218 from the light source 216, which may be controlled by the motive module 162, may selectively activate and deactivate changing patterns of DEP electrodes at regions 214 of the inner surface 208 of the electrode activation substrate 206.” Examiner notes that for Thaker to function an optically transmissive material in inherently used); …
Thaker discloses the above but does not explicitly disclose:
… (b) a dynamic light scattering assembly, the process chip configured to be removably positioned in relation to the dynamic light scattering assembly, …
… (c) a processor configured to determine viscosity of the fluid carrying the particles in the fluid chamber based on the captured light scattering data, the processor further configured to determine one or both of size or size distribution of particles in the fluid based on the captured light scattering data.
However, Knollenberg, in a similar field of endeavor (Slurry Monitor Coupling Bulk Size Distribution And Single Particle Detection), discloses:
… (b) a dynamic light scattering assembly (Knollenberg, FIG. 1, [0066], first probe 110 and second probe 120), the process chip configured to be removably positioned in relation to the dynamic light scattering assembly, …
… (c) a processor (Knollenberg, FIG. 1, [0068], controller 130) configured to determine viscosity of the fluid carrying the particles in the fluid chamber based on the captured light scattering data (Knollenberg, FIG. 1, [0069], “Particle detection system 100 may controllably change the flow rate of sample 008 through sample chamber 106, for example via a pump such as pump 102(I) and/or 102(II). The flow rate may be dynamically varied during characterization of sample 008.” Examiner notes that flow rate is inherently intertwined with viscosity), the processor further configured to determine one or both of size or size distribution of particles in the fluid based on the captured light scattering data (Knollenberg, Example 4, [0084], “a particle detection system comprises a first probe that is a dynamic light scattering probe configured or optimized for determining a concentration and/or size distribution of a plurality of small particles in a liquid sample”).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Thaker with the dynamic light scattering of Knollenberg. PHOSITA would have known about the uses of dynamic light scattering as disclosed by Knollenberg and how to use them to modify Thaker. PHOSITA would have been motivated to do this as a use of known technique to improve similar devices in the same way (See MPEP § 2143 (I)(C)), specifically the use of dynamic light scattering as described by Knollenberg on microdevice chambers as described by Thacker.
The combination of Thaker and Knollenberg discloses the above but does not explicitly disclose:
… the dynamic light scattering assembly including a source optical fiber configured to direct light through the optically transmissive material and into the fluid chamber, the dynamic light scattering assembly further including a sensing optical fiber configured to receive light scattered by particles in fluid in the fluid chamber in response to the source optical fiber emitting light into the fluid chamber and thereby capture light scattering data; and …
However, Simpson, in a similar field of endeavor (SYSTEMS, DEVICES AND METHODS ASSOCIATED WITH MICROFLUIDIC SYSTEMS), discloses:
… the dynamic light scattering assembly including a source optical fiber configured to direct light through the optically transmissive material and into the fluid chamber (Simpson, FIG. 1C, [0206], “the particles can be illuminated by a radiation source 112a (e.g., narrow band) via a fibre optic 114a”), the dynamic light scattering assembly further including a sensing optical fiber configured to receive light scattered by particles in fluid in the fluid chamber in response to the source optical fiber emitting light into the fluid chamber and thereby capture light scattering data (Simpson, FIG. 1C, [0206], “Fluorescence is transmitted by a second fibre optic 114b to an optical detector 116”); and …
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker and Knollenberg with the fiber optics of Simpson. PHOSITA would have known about the uses of fiber optics as disclosed by Simpson and how to use them to modify the combination of Thaker and Knollenberg. PHOSITA would have been motivated to do this as a simple substitution of one known element for another to obtain predictable results (See MPEP § 2143 (I)(B)), specifically the use of fiber optics to bring light to the sample and collect light for the detector.
Regarding Claim 2, the combination of Thaker, Knollenberg, and Simpson discloses Claim 1, and Thaker further discloses:
… a first channel, the fluid chamber inlet being configured to receive a first fluid from the first channel (Thaker, FIGS. 3B-3C, [0417], “the microfluidic device 200 may include a plurality of growth chambers or chambers and/or one or more flow regions or flow channels the microfluidic device 200 may include a plurality of growth chambers or chambers and/or one or more flow regions or flow channels”), and
a second channel, the fluid chamber inlet being further configured to receive a second fluid from the second channel (Thaker, FIGS. 3B-3C, [0417], “the microfluidic device 200 may include a plurality of growth chambers or chambers and/or one or more flow regions or flow channels the microfluidic device 200 may include a plurality of growth chambers or chambers and/or one or more flow regions or flow channels”).
Regarding Claim 3, the combination of Thaker, Knollenberg, and Simpson discloses Claim 1, and Thaker further discloses:
… wherein the first fluid comprises a therapeutic composition (Thaker, [0014], “detection and high-throughput drug screening, especially in a pandemic situation such as the Covid-19 pandemic requires rapid multifactorial evaluation of potential leads and candidate therapeutics”).
Regarding Claim 1, the combination of Thaker, Knollenberg, and Simpson discloses Claim 1, and Thaker further discloses:
… wherein at least some of the particles in the fluid in the fluid chamber form a therapeutic composition (Thaker, [0014], “In one example, therapeutic antibody discovery is a laborious, expensive process with high uncertainty during the discovery process”).
Regarding Claim 5, the combination of Thaker, Knollenberg, and Simpson discloses Claim 4, and Thaker further discloses:
… wherein the particles of the therapeutic composition comprises mRNA (Thaker, [0014], “detection and high-throughput drug screening, especially in a pandemic situation such as the Covid-19 pandemic requires rapid multifactorial evaluation of potential leads and candidate therapeutics.” Examiner notes that mRNA vaccines have been known in the art since at least 1990).
Regarding Claim 6, the combination of Thaker, Knollenberg, and Simpson discloses Claim 2, and Thaker further discloses:
… wherein the second fluid comprises a dilutant (Thaker, FIG. 3F, [0432], second medium 248. Examiner notes that as long as the second fluid is different from the first fluid, any second fluid would dilute the first fluid).
Regarding Claim 7, the combination of Thaker, Knollenberg, and Simpson discloses Claim 6, and Thaker further discloses:
… wherein the processor is configured to:
(i) selectively add discrete amounts of dilutant to the first fluid in a sequence;
(ii) track changes in scattering patterns of the captured light scattering data during the sequence to obtain autocorrelation data (Thaker, [0309], “a microchip configured to perform one or more miniaturized processes or tests (e.g., multiplexing, automation, high-throughput screening, analysis, assays, etc.) on one or more biological samples”), and
(iii) determine one or both of size or size distribution of particles in the fluid based on the autocorrelation data (Thaker, [0378], the one or more artificial intelligence modules 123 may identify segments of the associated data with metrics that exceed or fall below a certain threshold (e.g., a confidence level exceeding a first threshold, an estimated error below a second threshold, etc.) as a part of a training or benchmark dataset for training one or more models to improve the accuracy in their predictions of these one or more models).
Regarding Claim 8, the combination of Thaker, Knollenberg, and Simpson discloses Claim 6, and Thaker further discloses:
… wherein the process chip further includes a mixing chamber configured to mix the dilutant with the first fluid (Thaker, FIG. 3F, [0432], “a first fluidic medium 180 in the microfluidic channel 122A may mix with a second fluidic medium 248 in the isolation region 240 substantially by diffusion of components of the first medium 180 from the microfluidic channel 122A through the connection region 236 and into the second fluidic medium 248 in the isolation region 240”).
Regarding Claim 9, the combination of Thaker, Knollenberg, and Simpson discloses Claim 8, and Thaker further discloses:
… wherein the mixing chamber is positioned adjacent to the fluid chamber (Thaker, FIG. 3F, [0432], isolation chamber 240, shown in FIG. 3F as being part of chambers 226, 228 structure).
Regarding Claim 10, the combination of Thaker, Knollenberg, and Simpson discloses Claim 8, and Thaker further discloses:
… wherein the process chip further comprises a first pump and a second pump (Thaker, [0369], “A microfluidic device … may include an instrument that manipulates (e.g., by using active and/or passive components and/or micro-components such as micropumps, microvalves, etc.) a very small amount of fluid”), …
The combination of Thaker, Knollenberg, and Simpson discloses the above, but does not explicitly disclose:
… the first pump and the second pump being configured to alternatingly activate to thereby drive a combination of the dilutant and the first fluid back and forth through the mixing chamber.
However, as noted above, Thaker discloses the use of pumps to control the flow of the fluids into the microfluidic device. The exact mixture to be analyzed is a results-effective variable. In that, if the composition is not proper for analysis, the device would not operate properly. Given the small amounts of fluids being analyzed, adding to the mixture, as needed, small amounts at a time is a known means to control the composition.
Therefore, it would have been obvious to PHOSITA before applicant’s filing date to alternate the first and second pumps, since the needed mixture composition is based on a result effective variable and would require routine skill in the art. Furthermore, it has been held that that determining the optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05 (II (A) and (B)).
Regarding Claim 11, the combination of Thaker, Knollenberg, and Simpson discloses Claim 1, and Thaker further discloses:
… wherein the process chip further includes a plurality of mixing assemblies (Thaker, FIGS. 3D-3J, [0424], “Each chamber 224, 226, and 228 may comprise an isolation structure 232 defining an isolation region 240 and a connection region 236 fluidically connecting the isolation region 240 to a channel 122A”), each mixing assembly of the plurality of mixing assemblies having a plurality of inlets and an outlet, each mixing assembly of the plurality of mixing assemblies being configured to form a mixture of fluids from the plurality of inlets and communicate the mixture through the outlet (Thaker, FIG. 3F, [0432], “a first fluidic medium 180 in the microfluidic channel 122A may mix with a second fluidic medium 248 in the isolation region 240 substantially by diffusion of components of the first medium 180 from the microfluidic channel 122A through the connection region 236 and into the second fluidic medium 248 in the isolation region 240”).
Regarding Claim 12, the combination of Thaker, Knollenberg, and Simpson discloses Claim 11, and Thaker further discloses:
… wherein the fluid chamber is positioned downstream of one or more of the mixing assemblies of the plurality of mixing assemblies, such that the processor is configured to determine viscosity of the mixture and one or both of size or size distribution of particles in the mixture (Thaker, FIG. 3F, [0432], “components (not shown) of the second medium 248 in the isolation region 240 may mix with the first medium 180 in the microfluidic channel 122A substantially by diffusion of components of the second medium 248 from the isolation region 240 through the connection region 236 and into the first medium 180 in the microfluidic channel 122A”).
Regarding Claim 13, the combination of Thaker, Knollenberg, and Simpson discloses Claim 12, and Thaker further discloses:
… wherein the process chip further comprises a plurality of valves (Thaker, [0369], “A microfluidic device … may include an instrument that manipulates (e.g., by using active and/or passive components and/or micro-components such as micropumps, microvalves, etc.) a very small amount of fluid”), the plurality of valves being operable to selectively permit or prevent flow of fluid from the inlets into corresponding mixing assemblies of the plurality of mixing assemblies (Thaker, FIG. 3O, [0399], “Computer system 300O may transmit and receive messages, data, and instructions, including program (e.g., application code) through communication link 315O and communication interface 314O.” Examiner notes that for computer system 300O to execute the sequence of instructions to practice Thaker, computer system 300O would inherently control the valves to control the fluid flow).
Regarding Claim 14, the combination of Thaker, Knollenberg, and Simpson discloses Claim 13, and Thaker further discloses:
… wherein the processor is configured to selectively transition the plurality of valves between respective open and closed states (Thaker, FIG. 3O, [0399], “Computer system 300O may transmit and receive messages, data, and instructions, including program (e.g., application code) through communication link 315O and communication interface 314O.” Examiner notes that for computer system 300O to execute the sequence of instructions to practice Thaker, computer system 300O would inherently control the valves to control the fluid flow), …
Knollenberg further discloses:
… based at least in part on one or more of viscosity of the mixture, size of particles in the mixture, or size distribution of particles in the mixture (Knollenberg, FIG. 1, [0069], “Particle detection system 100 may controllably change the flow rate of sample 008 through sample chamber 106, for example via a pump such as pump 102(I) and/or 102(II). The flow rate may be dynamically varied during characterization of sample 008”).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker, Knollenberg, and Simpson with the flow rate monitoring of Knollenberg. PHOSITA would have known about the uses of flow rate monitoring as disclosed by Knollenberg and how to use them to modify the combination of Thaker, Knollenberg, and Simpson. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of flow rate monitoring to adjust the characteristics of the sample.
Regarding Claim 15, the combination of Thaker, Knollenberg, and Simpson discloses Claim 13, and Thaker further discloses:
… wherein the process chip further comprises a fluid input port and a fluid input manifold channel, the plurality of inlets of the plurality of mixing assemblies being fluidically coupled with the fluid input manifold channel (Thaker, FIGS. 3D-3J, [0424], “Each chamber 224, 226, and 228 may comprise an isolation structure 232 defining an isolation region 240 and a connection region 236 fluidically connecting the isolation region 240 to a channel 122A”).
Regarding Claim 19, the combination of Thaker and Knollenberg discloses Claim 16, and Thaker further discloses:
… the emitted light being communicated through an optically transmissive material on a first side of the process chip (Thaker, FIG. 3B, [0420], “changing patterns of light 218 from the light source 216, which may be controlled by the motive module 162, may selectively activate and deactivate changing patterns of DEP electrodes at regions 214 of the inner surface 208 of the electrode activation substrate 206.” Examiner notes that for Thaker to function an optically transmissive material in inherently used),
receiving the light scattered from the encapsulated particles (Thaker, FIG. 3A, [0476], “system 150A may include an imaging device 194. In some embodiments, the imaging device 194 comprises a light modulating subsystem 330 (See FIG. 3N),” and FIG. 3N, [0478], detectors 348), the received light being communicated through the optically transmissive material on the first side of the process chip, …
… performing autocorrelation on the received light (Thaker, [0309], “a microchip configured to perform one or more miniaturized processes or tests (e.g., multiplexing, automation, high-throughput screening, analysis, assays, etc.) on one or more biological samples”), and
determining a size or size distribution of the encapsulated particles using at least the autocorrelation (Thaker, [0378], the one or more artificial intelligence modules 123 may identify segments of the associated data with metrics that exceed or fall below a certain threshold (e.g., a confidence level exceeding a first threshold, an estimated error below a second threshold, etc.) as a part of a training or benchmark dataset for training one or more models to improve the accuracy in their predictions of these one or more models).
The combination of Thaker and Knollenberg discloses the above but does not explicitly disclose:
… emitting light toward the encapsulated particles via a first optical fiber the encapsulated particles scattering the emitted light, …
… the received light being received by a second optical fiber obliquely oriented relative to the first optical fiber, the first and second optical fibers being secured to a body positioned near the process chip, …
However, Simpson, in a similar field of endeavor (SYSTEMS, DEVICES AND METHODS ASSOCIATED WITH MICROFLUIDIC SYSTEMS), discloses:
… emitting light toward the encapsulated particles via a first optical fiber the encapsulated particles scattering the emitted light (Simpson, FIG. 1C, [0206], “the particles can be illuminated by a radiation source 112a (e.g., narrow band) via a fibre optic 114a”), …
… the received light being received by a second optical fiber obliquely oriented relative to the first optical fiber, the first and second optical fibers being secured to a body positioned near the process chip (Simpson, FIG. 1C, [0206], “Fluorescence is transmitted by a second fibre optic 114b to an optical detector 116”), …
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker and Knollenberg with the fiber optics of Simpson. PHOSITA would have known about the uses of fiber optics as disclosed by Simpson and how to use them to modify the combination of Thaker and Knollenberg. PHOSITA would have been motivated to do this as a simple substitution of one known element for another to obtain predictable results (See MPEP § 2143 (I)(B)), specifically the use of fiber optics to bring light to the sample and collect light for the detector.
Regarding Claim 21, the combination of Thaker, Knollenberg, and Simpson discloses Claim 1, and Thaker further discloses:
… the processor further configured to refine the determined one or both of size or size distribution of particles in the fluid based on the determined viscosity (Knollenberg, FIG. 1, [0069], “Particle detection system 100 may controllably change the flow rate of sample 008 through sample chamber 106, for example via a pump such as pump 102(I) and/or 102(II). The flow rate may be dynamically varied during characterization of sample 008.” Examiner notes that flow rate is inherently intertwined with viscosity).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify the combination of Thaker, Knollenberg, and Simpson with the threshold monitoring and flow rate monitoring of Knollenberg. PHOSITA would have known about the uses of threshold monitoring and flow rate monitoring as disclosed by Knollenberg and how to use them to modify the combination of Thaker, Knollenberg, and Simpson. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of threshold monitoring and flow rate monitoring to adjust the characteristics of the sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAD A REVERMAN whose telephone number is (571)270-0079. The examiner can normally be reached Mon-Fri 9-5 EST.
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/CHAD ANDREW REVERMAN/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877
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