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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/25/2023 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.
Claims 1-13 are rejected under 35 U.S.C. 102a1 as being anticipated by Chou et al. (US 2015/0253321 A1 – hereafter ‘321).
‘321 discloses a microfluidic device for detecting an analyte in a liquid (Abstract) that includes the following limitations for claim 1:
“A substance introduction device”: ‘321 discloses a microfluidic device (device 100; Fig. 1A; [0068]) that is being interpreted as the substance introduction device of the instant application.
“at least one turbulence grid that generates turbulence in a fluid containing a cell and a substance to be introduced into the cell”: ‘321 discloses a nanostructure layer (layer 132; Fig. 1C; [0068]) that is formed of disk-on-complimentary-plane antenna (DcP 200; Fig. 1D; [0086]) which is being interpreted as the turbulence gird of the instant application as these are equivalent structures to the claimed grid.
“at least a part of the at least one turbulence grid is formed of a conductive material that applies charge to the fluid.”: The top of the pillar or disk (disk 230) is made of a metallic cap (Fig. 1D; [0086]) that is a conductive material and fully capable of applying a charge to the fluid.
For claim 2, only a part of the grid of ‘321 is conductive such as the metal disks of the pillars is the conductive part (Fig. 1D; [0086]; disk 230).
For claim 3, ‘321 discloses inducing an electric field ([0097]) that is fully capable of providing a pulse.
For claim 4, ‘321 flows the liquid into an inlet ([0075]; inlet 150; Fig. 1A) that is delivered by a pump system ([0074]) which would be fully capable of adjusting the flow rate.
For claim 5, the electric field and charge of ‘321 is fully capable of being adjustable.
For claim 6, ‘321 discloses a microchannel (channel 120; Fig. 1A; [0068]) that is being interpreted as the circulation loop of the instant application.
For claim 7, ‘621 discloses the following limitations:
“an inlet interconnected with the circulation flow path and disposed on a first side of the at least one turbulence gride, wherein the inlet is configured to receive the fluid”: ‘321 discloses an inlet (inlet 150; Fig. 1A; [0069]) that is on one side of the grid and is configured receive a fluid.
“an outlet interconnected with the circulation flow path on a second side of the at least one turbulence grid, wherein the outlet is configured to discharge the cell comprising the substance to be introduced into the cell from the circulation flow path.”: ‘321 discloses an outlet (outlet 170; Fig. 1A; [0069]) that is on a second side of the grid and is configured to discharge a fluid or cell that is introduced into the microchannel.
For claim 8, ‘321 discloses the following limitation:
“the at least one turbulence grid comprises a plurality of bar-shaped members arranged adjacent one another in the circulation flow path, and wherein the plurality of bar-shaped members are configured to apply stress to the cell as the fluid moves through the at least one turbulence grid”: ‘321 discloses a protrusion (protrusion 220; Fig. 1D; [0086]) that has a pillar shape ([0058]). This pillar is being interpreted as the bar-shape of the instant application as bars commonly have a circular cross-sectional area within the art. Furthermore, the specification does not specifically limit the bar to a specific shape such as rectangular. Moreover, the pillars of ‘321 are adjacent to one another (Fig. 1D) and are fully capable of applying a stress to the cells since the pillars have the same shape and arrangement as the claimed grid of the instant application.
For claim 9, The microchannels of ‘321 are being interpreted as a closed loop shape.
For claim 10, ‘321 discloses the following limitations:
“A substance introduction method”: ‘321 discloses a microfluidic device (device 100; Fig. 1A; [0068]) that is being interpreted as the substance introduction method of the instant application.
“a stress/charge applying step of applying, while generating turbulence by flowing a fluid containing a cell and a substance to be introduced into the cell through at least one turbulence grid”: ‘321 discloses the step of applying physical stress to the fluid with a cell ([0199]) that is applied by the pillars. The flow of the fluid over the pillars would generate turbulence.
“charge to the cell in the fluid by a conductive material forming at least a part of he at least one turbulence grid.”: ‘321 supplies an electrical current to the conductive parts of the pillars ([0040]; [0097]; [0098]; [0165]; [0166]) that would charge a cell.
For claim 11, ‘321 discloses the step of depositing the gold layer on the sensor ([0096]) where this step is being interpreted as the conductive material adjusting step as this would adjust a ratio of conductive material on the pillars. Furthermore, this step can happen before the introduction of the fluid material, as interpreted in light of the specification, and being performed during the manufacture of the chip, therefore, reads on this limitation.
For claim 12, ‘321 discloses the step of controlling the liquid flow speed ([0078]), i.e. the flow rate.
For claim 13, ‘321 discloses the step of providing an electrical current ([0166]; [0183]) where this is being interpreted as a charge adjusting step.
Therefore, ‘321 meets the limitations for claims 1-13.
Allowable Subject Matter
Claims 14-20 are allowed.
The following is an examiner’s statement of reasons for allowance: For claim 14, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a substance introduction method that includes the following steps: introducing a fluid comprising a cell and a substance into a circulation flow path; flowing the fluid through at least one turbulence grid arranged in the circulation flow path, wherein flowing the fluid through the at least one turbulence grid generates turbulence in the fluid; and applying a charge to the fluid simultaneously as the fluid passes through the at least one turbulence grid and as the turbulence in the fluid is generated, causing the substance to be introduced into the cell.
The closest prior art is Chou et al. (US 2015/0253321 A1) that discloses a microfluidic device that detects an analyte that includes a sensor layer made of micropillars with a conductive disk, but Chou does not teach or suggest the step of generating a turbulence in the fluid while simultaneously applying a charge to the fluid as the cell passes the micropillars in order to introduce a substance into a cell.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 15-20 would be allowable for the same reasons as claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chander et al. (US 2016/0272934 A1) that discloses a device for dissociating tissue within a microfluidic device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799