DETAILED ACTION
In application filed on 06/23/2023, Claims 1-27 are pending. The claim set submitted on 5/23/2024 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-12 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/23/2023 and 10/31/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/20/2026 is acknowledged. Claims 13-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/20/2026.
Group I, Claims 1-12 are considered on the merits below.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 recites the limitation “microchamber” in line 5.
Is the “dead-end microchambers” same as the “each microchamber” in line 6?
For the purpose of expedited prosecution, Examiner interprets “the microchamber” as “each dead-end microchamber”.
Appropriate correction is required.
Claim 6 recites the limitation “the microfluidic circuit” in line 1 .
Is the “the circuit” same as the “the microfluidic circuit” ?
For the purpose of expedited prosecution, Examiner interprets “the circuit” as “the microfluidic circuit”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 9 and 11-12 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Mershin et al. (US20150037890A1, submitted in the IDS of 06/23/2023)
Regarding Claim 1, Mershin et al teaches: a microfluidic circuit (referred to as apparatus [Para 0197]) comprising:
an inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]);
an outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113]);
a main channel (referred to as main channel [Para 0082; Fig. 1, ref. 121]) fluidically connecting the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]) and(See Figs. 1-2) the outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113]); and
a series of dead-end microchambers (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) of differing volumes (See Para 0032…FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G show different examples of sizes and shapes of microfluidic chambers.), wherein each microchamber (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) is individually fluidically connected (See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128) has an opening (e.g., 130, 131, 132, 133) to the main channel 121) to the main channel (referred to as main channel [Para 0082; Fig. 1, ref. 121]) via a side channel (referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C).
Regarding Claim 2, Mershin teaches wherein the side channels(referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C) comprise a passage (referred to as the space or volume capacity of the structural embodiment an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C) having a lower volume capacity than (See Fig. 2C…it appears that the volume capacity of the of the structural embodiment an opening is smaller than the volume capacity of the main channel) that of the main channel (referred to as main channel [Para 0082; Fig. 1, ref. 121]).
Regarding Claim 3, Mershin teaches that the side channels (referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C) are each identical in size, shape, and volume capacity (See Fig. 2C for identical in size, shape, and volume capacity).
Regarding Claim 6, Mershin teaches that the circuit (referred to as apparatus [Para 0197]) comprises 2,3,4,5,6,7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or more than 24 microchambers (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)).
Regarding Claim 9, Mershin teaches that the main channel (referred to as main channel [Para 0082; Fig. 1, ref. 121]) comprises a linear shape (See Fig. 2C for the linear shape of the main channel).
Regarding Claim 11, Mershin teaches that the series of microchambers referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) are arranged in equally-sized pairs positioned on either side (See Fig. 2C for…arranged in equally-sized pairs positioned on either side) of the main channel (referred to as main channel [Para 0082; Fig. 1, ref. 121]).
Regarding Claim 12, Mershin teaches that the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]) and outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113])comprise a blocking element (See Para 0108… outlet tube (e.g., 921, 923, 925) controlled by a separate valve or valve port (e.g., 931, 933, 935; See Para 0113… The first valve 1101 allows recipient cells and donor genetic material to enter the microfluidic device; See Para 0116,,, The fourth valve 1131 can used to open or shut outlet channel 1133 and outlet channel 1135.; Also See Para 0119… he inlet valves and outlet valves may be closed).
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 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over by Mershin et al. (US20150037890A1, submitted in the IDS of 06/23/2023) in view of Branch et al. (US9096823B1).
Regarding Claim 4, Mershin teaches the side channel (referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C). Mershin further teaches that in exemplary implementations, a microfluidic device includes features with various geometries and length scales, from microns to centimeters (See Para 0047).
Mershin does not explicitly teach that the side channel comprises a serpentine configuration.
In the analogous art relating to the lysis of biological cells and, in particular, to a microfluidic device and method for cell lysis by localized acoustic pressure, Branch teaches that the side channel comprises a serpentine configuration (See Col. 2, lines 57-59…the channel can be a straight channel or can be a circuitous or serpentine channel to increase the exposure time to the acoustic pressure field).
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 a microfluidic circuit of Mershin to include that the side channel comprises a serpentine configuration, as taught by Branch for the benefit of increasing the exposure time of biological cells to the acoustic pressure for lysing (Branch, Col. 2, lines 40-60), allowing for the provision of an acoustic-based microfluidic lysing device that can be integrated with an on-chip nucleic acid extraction processing capability and can be used in a field portable system (Branch, Col. 2, lines 34-37).
Regarding Claim 5, Mershin teaches the side channel (referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C) comprises an opening width (See Fig. 2C for the opening width), the side channel (referred to as the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C) comprises a configuration (the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C] has a configuration) with a switchback length at the shortest distance the structural embodiment of an opening (e.g., 130, 131, 132, 133) [Para 0082; Fig. 2C] has a switchback length at the shortest distance), the microchambers (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) comprise a diameter (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128) has a diamater), the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]) comprises a diameter the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]) and(See Figs. 1-2) the outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113]; has a diameter);, and the outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113]) comprises a diameter (referred to as outlet [Para 0080; Fig. 1, ref. 113]; has a diameter).
While Mershin teaches that in exemplary implementations, a microfluidic device includes features with various geometries and length scales, from microns to centimeters (Para 0047).
Mershin does not explicitly teach that the side channel comprises a serpentine configuration.
In the analogous art relating to the lysis of biological cells and, in particular, to a microfluidic device and method for cell lysis by localized acoustic pressure, Branch teaches that the side channel comprises a serpentine configuration (See Col. 2, lines 57-59…the channel can be a straight channel or can be a circuitous or serpentine channel to increase the exposure time to the acoustic pressure field).
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 a microfluidic circuit of Mershin to include that the side channel comprises a serpentine configuration, as taught by Branch for the benefit of increasing the exposure time of biological cells to the acoustic pressure for lysing (Branch, Col. 2, lines 40-60), allowing for the provision of an acoustic-based microfluidic lysing device that can be integrated with an on-chip nucleic acid extraction processing capability and can be used in a field portable system (Branch, Col. 2, lines 34-37).
The combination of Mershin and Branch does not explicitly teach that length scales, geometries and dimensions where the side channel comprises an opening width of 40-100 µm, the side channel comprises a serpentine configuration with a switchback length at the shortest distance of 500-1500 µm, the microchambers comprise a diameter between 200-1500 µm, the inlet port comprises a diameter of 500-1500 µm, and the outlet port comprises a diameter of 500-1500 µm.
However, the combination of Mershin and Branch does teach that the device of Claim 1 is a microfluidic circuit where the only difference between the prior art and the claim is that length scales, geometries and dimensions where the side channel comprises an opening width of 40-100 µm, the side channel comprises a serpentine configuration with a switchback length at the shortest distance of 500-1500 µm, the microchambers comprise a diameter between 200-1500 µm, the inlet port comprises a diameter of 500-1500 µm, and the outlet port comprises a diameter of 500-1500 µm.
The Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP § 2144.05, Part II, Subpart B; In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a microfluidic device where the length scales, geometries and dimensions and where the side channel comprises an opening width of 40-100 µm, the side channel comprises a serpentine configuration with a switchback length at the shortest distance of 500-1500 µm, the microchambers comprise a diameter between 200-1500 µm, the inlet port comprises a diameter of 500-1500 µm, and the outlet port comprises a diameter of 500-1500 µm, for the benefit of facilitating high-throughput, parallel testing and procedures (Mershin, Para 0025).
Regarding Claim 7, Mershin teaches the microchambers (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)).
Mershin does not explicitly teach that the side channel comprise a circular shape.
In the analogous art relating to the lysis of biological cells and, in particular, to a microfluidic device and method for cell lysis by localized acoustic pressure, Branch teaches that the side channel comprises a serpentine configuration (See Col. 2, lines 57-59…the channel can be a straight channel or can be a circuitous or serpentine channel to increase the exposure time to the acoustic pressure field).
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 a microfluidic circuit of Mershin to include that the side channel comprises a circular shape, as taught by Branch for the benefit of increasing the exposure time of biological cells to the acoustic pressure for lysing (Branch, Col. 2, lines 40-60), allowing for the provision of an acoustic-based microfluidic lysing device that can be integrated with an on-chip nucleic acid extraction processing capability and can be used in a field portable system (Branch, Col. 2, lines 34-37).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mershin et al. (US20150037890A1, submitted in the IDS of 06/23/2023) in view of Branch et al. (US9096823B1) as applied to claim 7.
Regarding Claim 8, the microfluidic circuit of claim 7 is obvious over Mershin in view of Branch.
Mershin teaches each microchamber (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) varying in diameter (See Para 0032…FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G show different examples of sizes and shapes of microfluidic chambers) and the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]).
The combination of Mershin and Branch does not teach that each microchamber increases in diameter as its position increases in distance from the inlet port.
However, one having ordinary skill in the art at the time the invention was made would recognize these limitations as nothing more than a rearrangement of parts to effect the determination of the optimal structural configuration and design of the device and could seek the benefits associated with having each microchamber increasing in diameter as its position increases in distance from the inlet port, given that a rearrangement of parts is a supporting rationale of obviousness especially because the combination of Mershin and Branch discloses all the claimed structures of as cited above only in a different configuration (under broadest reasonable interpretation). Please see MPEP 2144.04(VI) (C) for further details.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rearrangement of the position of each microchamber increasing in diameter as its position increases in distance from the inlet port, for the benefit of providing a device of optimal structural design facilitating device compactness and the optimal performance which allows for facilitating high-throughput, parallel testing and procedures (Mershin, Para 0025).
Regarding Claim 10, Mershin teaches that the series of microchambers (referred to as microfluidic chambers [Para 0082; Fig. 2A, ref. 123]; Also See Para 0082…Each of these microfluidic chambers (e.g., 125, 126, 127, 128)) are arranged in size of varying volumes (See Para 0032…FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G show different examples of sizes and shapes of microfluidic chambers) near the inlet port (referred to as inlet [Para 0080; Fig. 1, ref. 109]) towards the outlet port (referred to as outlet [Para 0080; Fig. 1, ref. 113]).
Mershin does not teach that the series of microchambers are arranged in size of graduated volumes from lowest to highest from the inlet port towards the outlet port.
However, one having ordinary skill in the art at the time the invention was made would recognize these limitations as nothing more than a rearrangement of parts to effect the determination of the optimal structural configuration and design of the device and could seek the benefits associated with having that the series of microchambers are arranged in size of graduated volumes from lowest to highest from the inlet port towards the outlet port, given that a rearrangement of parts is a supporting rationale of obviousness especially because Mershin discloses all the claimed structures of as cited above only in a different configuration (under broadest reasonable interpretation). Please see MPEP 2144.04(VI) (C) for further details.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rearrangement of the position of the series of microchambers being arranged in size of graduated volumes from lowest to highest from the inlet port towards the outlet port, for the benefit of providing a device of optimal structural design facilitating device compactness and the optimal performance which allows for facilitating high-throughput, parallel testing and procedures (Mershin, Para 0025).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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