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 .
Status of Claims
The claim set submitted on 07 MAY 2024 is acknowledged and considered. In the claim set, Claims 1-20 are presented and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 15 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 15 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6, 7, 10 and 12-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by KOSWARA, US Publication No. 2019/0176122 A1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference KOSWARA discloses a microfluidic device, Figure 1A, each individual module, comprising:
two or more solution inlets each adapted to receive a respective solution, Figure 1A, at last first of top left modules with more two or more inlets with adapted to receive a respective solution, i.e. NaOH Lisinopril Ester, each of the two or more solution inlets adapted to be selectively opened and closed, [0030], valve;
two or more loading channels each coupled to a respective solution inlet, each loading channel adapted to hold the respective solution, Figure 1A, at last first of top left modules with more two or more channels, [0065];
a fluidic force inlet coupled to the two or more solution inlets and adapted to provide a fluidic force to each respective loading channel via the respective solution inlet, [0030], pumps, Figure 1B, syringe pumps; and
a mixing channel coupled to the two or more loading channels, thereby adapted to mix each solution held in each of the two or more loading channels when the fluidic force is applied to the fluidic force inlet, Figure 1B, microreactor, serpentine configuration, [0088], the mixing channel terminating at a trap zone adapted to receive the mixed solution from the mixing channel when exposed to the fluidic force, the trap zone including a fluidic force outlet adapted to release the received fluidic force, Figure 3, at outlet tubing and Raman microscope intersection is a zone to received mixed solution, [0028].
Additional Disclosures Included are: Claim 4: wherein the microfluidic device of claim 1, wherein each of the two or more solution inlets adapted to be selectively closed and opened utilizing an inlet closing device, [0030], valves, [0061, 0063]. ; and Claim 6: wherein the microfluidic device of claim 1, the fluidic force inlet is adapted to receive the fluid force from a syringe, [0030, 0061, 0067].
Regarding Claim 7, the KOSWARA reference discloses a microfluidic system, Figure 1A-1C and 3, comprising:
two or more solution inlets each adapted to receive a respective solution, Figure 1A, at last first of top left modules with more two or more inlets with adapted to receive a respective solution, i.e. NaOH Lisinopril Ester, each of the two or more solution inlets adapted to be selectively opened and closed, [0030], valve;
two or more loading channels each coupled to a respective solution inlet, each loading channel adapted to hold the respective solution, Figure 1A, at last first of top left modules with more two or more channels, [0065];
a fluidic force inlet coupled to the two or more solution inlets and adapted to provide a fluidic force to each respective loading channel via the respective solution inlet, [0030], pumps, Figure 1B, syringe pumps; and
a mixing channel coupled to the two or more loading channels, thereby adapted to mix each solution held in each of the two or more loading channels when the fluidic force is applied to the fluidic force inlet, Figure 1B, microreactor, serpentine configuration, [0088], the mixing channel terminating at a trap zone adapted to receive the mixed solution from the mixing channel when exposed to the fluidic force, the trap zone including a fluidic force outlet adapted to release the received fluidic force, Figure 3, at outlet tubing and Raman microscope intersection is a zone to received mixed solution, [0028];
a fluidic force device coupled to the fluidic force inlet adapted to generate the fluid force, [0030, 0061, 0067]; and
a microscope system optically coupled to the trap zone adapted to irradiate the mixed solution with a light source and return optical emission from the mixed solution to an image capture device, Figure 3, 4A, [0014, 0045, 0070, 0136].
Additional Disclosures Included are: Claim 10: wherein the microfluidic system of claim 7, wherein each of the two or more solution inlets adapted to be selectively closed and opened based on application of an inlet closing device, [0030], valves, [0061, 0063].; Claim 12: wherein the microfluidic system of claim 7, the fluidic force device is syringe, [0030, 0061, 0067].; Claim 13: wherein the microfluidic system of claim 7, further comprising: a pressure sensor coupled to the fluidic force inlet adapted to generate a signal associated with pressure in the two or more loading channels and the mixing channel, [0030, 0032, 0077].; Claim 14: wherein the microfluidic system of claim 13, further comprising: a processor executing software on a non-transient memory, [0070, 0075], configured to: receive a pressure signal from the pressure sensor; control the fluidic force device to thereby selectively apply a fluidic force based on a predetermined schedule in response to the received pressure signal, [0032], during process integration and optimization , the process decision variables…pressure are varied to achieve desired trade-off between yield, purity and throughput. ; and Claim 15: wherein the microfluidic system of claim 14, further comprising: a temperature sensor disposed about the trap zone and adapted to provide a temperature signal associated with temperature of the mixed solution in the trap zone, [0085, 0086].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 3, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over KOSWARA, US Publication No. 2019/0176122 A1.
Regarding Claim 2, the reference KOSWARA discloses the claimed invention of the microfluidic device of claim 1 but is silent in regards to wherein one or more of the two or more loading channels is serpentine-shaped, thus adapted to hold a predetermined amount of the respective solution.
However, KOSWARA discloses the shape of channels can be varied by any method known to those of ordinary skill in the art, [0057]. In addition, in the device of KOSWARA the mixing channel is already taught to be of serpentine shape in the microfluidic device, [0129].
Therefore it would be obvious to one having ordinary skill in the art before the effective filing date to modify the shape of the loading channel to be of known serpentine-shaped as taught in another channel of the device to increase the distance (total amount of predetermine solution) a respective solution has to flow prior to mixing , increase the overall capacity of the microfluidic device when an amount of solution is supplied to the device and to save space of the overall footprint of the microfluidic device. In addition, the change in shape of the channels is obvious as] a matter of choice absent persuasive evidence that the particular configuration of the claimed container was significant, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) .
Regarding Claim 3, the KOSWARA discloses the claimed invention of the microfluidic device of claim 1, including wherein the mixing channel is serpentine shaped, [0129], thus adapted to provide sufficient volume for mixing of the respective solutions based on a predetermined volume criterion, [0129], and wherein the mixing channel is defined by a length of between about 1 cm and about 20 cm, Figure 1, 2, [0033], reactor’s channel range from micrometer to the millimeter, length is in the meter scale, but is silent in regard to a diameter of about 1 µm and about 1 mm.
KOSWARA discloses microreactor’s channel flow depends on the diameter of the channel and the dimensions of the channel to allow for a certain volumetric or linear flow rate of fluid through the channel, [0057, 0063].
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the diameter of the channel to be about 1 µm and about 1 mm, to allow and control a certain volumetric or linear flow rate of fluid in the channel, [0057].
Regarding Claim 8, the reference KOSWARA discloses the claimed invention of the microfluidic device of claim 7 but is silent in regards to wherein one or more of the two or more loading channels is serpentine-shaped, thus adapted to hold a predetermined amount of the respective solution.
However, KOSWARA discloses the shape of channels can be varied by any method known to those of ordinary skill in the art, [0057]. In addition, in the device of KOSWARA the mixing channel is already taught to be of serpentine shape in the microfluidic device, [0129].
Therefore it would be obvious to one having ordinary skill in the art before the effective filing date to modify the shape of the loading channel to be known serpentine-shaped as taught in another channel of the device to increase the distance (total amount of predetermine solution) a respective solution has to flow prior to mixing , increase the overall capacity of the microfluidic device when an amount of solution is supplied to the device and to save space of the overall footprint of the microfluidic device. In addition, the change in shape of the channels is obvious as] a matter of choice absent persuasive evidence that the particular configuration of the claimed container was significant, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) .
Regarding Claim 9, the KOSWARA discloses the claimed invention of the microfluidic device of claim 7, including wherein the mixing channel is serpentine shaped, [0129], thus adapted to provide sufficient volume for mixing of the respective solutions based on a predetermined volume criterion, [0129], and wherein the mixing channel is defined by a length of between about 1 cm and about 20 cm, Figure 1, 2, [0033], reactor’s channel range from micrometer to the millimeter, length is in the meter scale, but is silent in regard to a diameter of about 1 µm and about 1 mm.
KOSWARA discloses microreactor’s channel flow depends on the diameter of the channel and the dimensions of the channel to allow for a certain volumetric or linear flow rate of fluid through the channel, [0057, 0063].
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the diameter of the channel to be about 1 µm and about 1 mm, to allow and control a certain volumetric or linear flow rate of fluid in the channel, [0057].
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over KOSWARA, US Publication No. 2019/0176122 A1 and further in view FALB, US Publication No. 2009/0269248 A1.
Regarding Claims 5 and 11, the KOSWARA reference teaches the invention of Claims 4 and 10, respectively, but is silent in regards to wherein the inlet closing device is a pressure sensitive adhesive.
FALB discloses a chip , Figure 3A, 3B, cartridge 201, [0057], comprising:
two or more solution inlets each adapted to receive a respective solution, Figure 3B, inlets 331a-h, with reservoir 342a-h, [0057], each of the two or more solution inlets adapted to be selectively opened and closed, [0030], valve;
two or more loading channels each coupled to a respective solution inlet, each loading channel adapted to hold the respective solution, Figure 3B, [0061]; wherein each of the two or more solution inlets adapted to be selectively closed and opened utilizing an inlet closing device , wherein the inlet closing device is a pressure sensitive adhesive, Figure 3B, [0061].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the inlet closing device so that it is a pressure sensitive adhesive as taught by FALB to close the inlet without use of any reactive adhesives or any other mechanical mechanisms to close the inlet and only requires pressure to close the device.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over KOSWARA, US Publication No. 2019/0176122 A1 and further in view of CLAYTON, US Publication No. 2019/0072472 A1.
Regarding Claim 16, the reference KOSWARA discloses the claimed invention, but is silent in regards to wherein the processor is further configured to determine size of particles in the solution in the trap zone by application of particle diffusometry.
The CLAYTON discloses a system and processor configured processor configured to determine size of particles in the solution in a trap zone by application of particle diffusometry, abstract, Figure 3, [0022, 0032].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the processor of KOSWARA so that it is configured to determine size of particles in the solution in a trap zone by application of particle diffusometry as taught by CLAYTON because it quickly quantifies how quickly particle move through a medium to accurately predict transport rates, optimize heat treatment cycles, or control doping in semiconductors and ensuring accurate predictions of concentration profiles over time.
Additional Disclosures Included are: Claim 17: wherein the microfluidic system of claim 16, wherein application of particle diffusometry includes steps of: dividing a field of view of images captured by the image capture device into one or more segments; for each of the one or more segments: identify particles at two or more time intervals: for each of the two or more time intervals: obtain autocorrelation of first plurality of particles for a first timeslot according to locations of said first plurality of particles at the first timeslot, identify an autocorrelation peak in the autocorrelation, obtain cross-correlation of second plurality of particles for a second timeslot according to locations of said second plurality of particles as compared to said first plurality of particles from the first timeslot, identify a cross-correlation peak in the cross-correlation, for each identified autocorrelation and cross-correlation peaks, determine peak widths at 1/e of each peak, and determine time-dependent particle size based on the determined peak widths as a function of time, abstract, [0007], Claim 7.
It should be noted that the instant claim language is directed towards a method of intended use and operation of the apparatus rather than further defining a structural feature that accomplishes these functions. The instant invention is directed towards an apparatus, a microfluidic system. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
How the particle diffusivity is intended to be used does not differentiate the instant invention from the prior art structurally.
Regarding Claim 18, the combination of KOSWARA in view of CLAYTON suggests the claimed invention directed to a microfluidic system of claim 17.
However, the combination is silent in regard to the formula of the time-dependent particle size.
Nevertheless, as stated above claim 17 is directed towards a method of intended use of the apparatus rather than a structural feature that accomplishes these functions. The instant invention is directed towards an apparatus, a microfluidic system. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Instant Claim 18 is also directed toward a method of intended use and how the processor is to be operated.
CLAYTON discloses a system and processor configured processor configured to determine size of particles in the solution in a trap zone by application of particle diffusometry, abstract, Figure 3, [0022, 0032].
It would be obvious to one having ordinary skill in the art before the effective filing date to use the formula of
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to accurately determine size of each particle.
Regarding Claim 19, the combination above suggests microfluidic system of claim 17, including the processor is further configured to determine time-dependent binding performance between particles suspended in the respective solutions of the two or more loading channels, CLAYTON abstract, [0007], Claim 7, first time and second time.
Regarding Claim 20, the combination of KOSWARA in view of CLAYTON suggests the claimed invention directed to a microfluidic system of claim 17.
However, the combination is silent in regard to the formula of the time-dependent particle size.
Nevertheless, as stated above claim 17 is directed towards a method of intended use of the apparatus rather than a structural feature that accomplishes these functions. The instant invention is directed towards an apparatus, a microfluidic system. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Instant Claim 20 is also directed toward a method of intended use and how the processor is to be operated.
CLAYTON discloses a system and processor configured processor configured to determine size of particles in the solution in a trap zone by application of particle diffusometry, abstract, Figure 3, [0022, 0032].
It would be obvious to one having ordinary skill in the art before the effective filing date to use the formula of
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for calculating the time-dependent performance to accurately describe how the strength or effect of a molecule’s binding to its target changes over time, rather than being constant from the moment of contact.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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