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 .
Applicant’s amendment has been considered and entered for the record.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the cell solution" in lines 12 and 13. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-13 and 20 are rejected under 35 U.S.C. 112b as the claims depend upon and incorporate all the limitations of claim 1.
Appropriate corrective action 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 (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.
Claim(s) 1-4, 7, 12 and 13 are rejected under 35 U.S.C. 102a1 as being anticipated by Broyer et al. (US 2017/0241878 A1 – hereafter ‘878)
‘878 discloses a system for treating biological cells such as blood (Abstract) that includes the following limitations for claim 1:
“A cell transformation cartridge”: ‘878 discloses a microfluidic device (device 10; Fig. 1; Fig. 2a; [0155]) that is being interpreted as the cartridge of the instant application. This is being interpreted as the cell transformation cartridge of the instant application since the microfluidic device of ‘878 includes all the structural features of claim 1.
“a body unit, in which a cell flow path, a material flow path, and a resultant flow path that meet one another are formed”: ‘878 discloses a body unit (cover plate 21 and separator 22; Fig. 2a) that is being interpreted as the body unit of the cartridge ([0155]). This includes a cell and material flow path (paths 40a-40b) and a resultant channel (path 50) that meat one another in the unit ([0156]).
“an electric field forming unit, which comprises an electrode being connected to the body unit to create an electric field in a resultant flow path”: ‘878 discloses electrodes (electrodes 3000; Fig. 7a; [0214]) that are deposited in the substrate and apply an electric field to the separation channel (channel 50).
“wherein the cell flow path and the material flow path are formed in a shape that converges to the resultant flow path”: The inlet flow paths are formed to converge into the resultant or separation flow path (Fig. 1; [0155]; [0156]).
“wherein the resultant flow path comprises a mixing flow path extending from a location being connected to the cell flow path and the material flow path”: ‘878 discloses that the resultant or separation path extends from a connection point of the flow channels to an outlet (Fig. 1; [0155]; [0156]).
“wherein the thickness of the mixing flow path is smaller than that of the cell flow path”: The thickness of the inlet (inlets 30a-c) are being interpreted as having a thickness greater than the separation channel (Fig. 2a).
“wherein the thickness of a solution flowing into the mixing flow path through the cell flow path within the mixing flow path is smaller than the diameter of the cells contained in a cell solution”: This is drawn to the material operated on by an apparatus which does not structurally define the claimed invention over the prior art. Specifically, this is drawn to the solution provided to the cartridge and not the size of any particular channel within the cartridge. See also MPEP §2115.
For claim 2, the inlet flow paths (paths 40a-c) which would include a cell flow path and a material flow path meet at a junction with the separation channel (Fig. 1).
For claim 3, the inlets of ‘878 would read on the cell introduction flow path which extends downward from the cover the microfluidic device ([0155; Fig. 1; Fig. 2).
For claim 4, ‘878 discloses that the separation/mixing flow path extends in a horizontal direction from the inlet channels (Fig. 1; [0155]).
For claim 7, that the material introduction flow path, (inlet 30b; Fig. 1; Fig. 2a) extends downward from the top of the cover plate and that the conveying channel (channel 40b) extends horizontally from a lower end of the inlet and toward the separation/resultant flow path ([0156]).
For claim 12, ‘878 discloses an exit flow path from the separation flow path (Fig. 2a; conveying channel 70b; outlet 60b; [0157]) that is connected to the separation flow path and the outlet.
For claim 13, ‘878 discloses that the separation channel has a depth of 100 to 150 mm ([0167]).
Therefore, ‘878 meets the limitations of claims 1-4, 7, 12 and 13.
Claim(s) 1-4, 7, 9-13 and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Corso et al. (US 2020/0399578 A1 – hereafter ‘578)
‘578 discloses a system for treating biological cells such as blood (Abstract) that includes the following limitations for claim 1:
“A cell transformation cartridge”: ‘878 discloses a system for electroporation (Abstract) where the method of electroporation is being interpreted as the transformation of the instant application. ‘578 further discloses an electroporation chip ([0101]) which is being interpreted as the cartridge of the instant application.
“a body unit, in which a cell flow path, a material flow path, and a resultant flow path that meet one another are formed”: ‘578 discloses a flow chip (i.e. the body unit; Fig. 11; [0130]) that includes a cell flow path (cell medium entrance port (Fig. 11; i.e. the cell flow path), a transfection reagent entrance (Fig. 11; i.e. the material flow path) and a path after the reagent port that is being interpreted as the resultant flow path (Fig. 11; [0130]).
“an electric field forming unit, which comprises an electrode being connected to the body unit to create an electric field in a resultant flow path”: ‘’578 discloses electrodes in a magnetic selection region and an electroporation region (Fig. 11; [0143]) which would create an electric field in the resultant flow path.
“wherein the cell flow path and the material flow path are formed in a shape that converges to the resultant flow path”: The cell entrance path and the reagent entrance of ‘578 converges into a common flow path (Fig. 11).
“wherein the resultant flow path comprises a mixing flow path extending from a location being connected to the cell flow path and the material flow path”: The mixing flow path of ‘578 would be right after the reagent entrance port where both streams “mix” (Fig. 11; [0143]).
“wherein the thickness of the mixing flow path is smaller than that of the cell flow path”: ‘578 shows that the thickness (depth) of the cell entrance port is thicker than the resultant or mixed flow path (Fig. 8).
“wherein the thickness of a solution flowing into the mixing flow path through the cell flow path within the mixing flow path is smaller than the diameter of the cells contained in a cell solution”: This is drawn to the material operated on by an apparatus which does not structurally define the claimed invention over the prior art. Specifically, this is drawn to the solution provided to the cartridge and not the size of any particular channel within the cartridge. See also MPEP §2115.
For claim 2, ‘578 discloses where the cell flow pathway (path 205; Fig. 5) is above the reagent or material path (path 203; Fig. 5; [0055]).
For claim 3, the cell entrance flow port extends down into the substrate from an opening in the top of the chip (Fig. 8).
For claim 4, the flow path after the reagent entrance or the mixing flow path extends in a horizontal direction from the cell entrance port and the reagent port (Fig. 8; Fig. 11; [0143]; [0147]).
For claim 7, the reagent port or flow path (Fig. 8; Fig. 11; [0143]; [0147]) extends downward into the chip and has a portion of the channel which extends from the bottom of the port to the electroporation region or resultant flow path (see bottom two images of Fig. 8, center cross section and the center cross section expanded).
For claim 9, ‘578 discloses a second material flow path (from entrance 204; Fig. 5) that is on one side of the cell flow path (path 205) and a first material flow path that is on the opposite side of the cell flow path (path from entrance 203; Fig. 5; [0055]).
For claim 10, the first flow path (path 203) is below the cell flow path (path 205; Fig. 5) and the second flow path is above the cell flow path (reagent flow path 205; Fig. 5; [0055]).
For claim 11, ‘578 discloses that the electric field is applied in pulses ([0013]) by a variable-voltage power source ([0096]).
For claim 12, ‘578 discloses that the electroporation section/resultant flow path is connected to an outlet by an additional length of channel (Fig 5; [0055]) where this can include a cell collection reservoir (reservoir 603; Fig. 4; [0126]).
For claim 13, ‘578 discloses that the thickness of the channel is approximately 100 microns (for flow paths 105, 13 7 104; Fig. 2) which is within the claimed range.
For claim 20, ‘578 discloses that the flow paths are at 90° to one another (Fig. 5; [0061]; [0062]).
Therefore, ‘578 meets the limitations of claims 1-4, 7, 9-13 and 20.
Allowable Subject Matter
Claims 5, 6 and 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 5, 6 and 8 are only rejected under 35 U.S.C. 112b since the claims depend upon and incorporate all the limitations of claim 1. Furthermore,
For claim 5, the prior art fails to teach or fairly suggest where the material flow path has the shape of an downward convex arc.
Claim 6 would be allowable for reasons similar to claim 5.
For claim 8, the prior art fails to teach or fairly suggest where an inlet of the material flow path, an inlet of the cell flow path, and an outlet of the resultant flow path are arranged in the order of the inlet of the material flow path, the inlet of the cell flow path, and the outlet of the resultant flow path along the reference direction.
Claims 14-19 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 cell transformation device that includes the following limitations: a pump unit, which is provided for pressurized supply of a cell solution and a material solution to a cell flow path and a material flow path of a cell transformation cartridge, respectively; a power application unit, which is provided to be connected to a terminal of the cell transformation cartridge to apply power to an electrode of the cell transformation cartridge; and a processor, which is electrically connected to the power application unit and the pump unit, wherein the processor controls the pump unit based on the information of the cell transformation cartridge, a preset flow ratio, and a preset exposure time.
For claim 15, 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 cell transformation system that includes a body unit with a cell flow path, a material flow path and a resultant flow path that meet one another and where an electrode is connected to the body unit is connected to the body unit and is placed at an inlet of the material flow path and the outlet of the resultant flow path and a pump unit is provided for the pressurized supply of a cell solution and a material solution. Furthermore, a processor controls the pump unit in a way that the thickness of the solution flow into the mixing flow path through the cell flow path within the mixing flow path is smaller than the diameter of the cells contained in the cell solution.
For claim 16, 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 cell transformation where the ratio between the flow rate of the cell solution and the flow rate of the material solution being injected is a value that allows transformation to occur when the cells and the material meet in the mixing flow path.
Claims 17-19 would be allowable for the same reasons as claim 16.
The closest prior art is Broyer et al. (US 2017/0241878 A1) which discloses a system for treating biological cells, but does not teach or fairly suggest the limitations of claims 14-19.
The next closest prior art is Corso et al. (US 2002/0399578 A1) which discloses a system for electroporation on a chip, but Corso does not teach or fairly suggest the limitations of claims 14-19.
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.”
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive. With regards to the Broyer reference, Applicant argues in the fifth paragraph on page 6 that the applied reference does not teach “the thickness of a solution flowing into the missing flow path through the cell flow path within the mixing flow path is smaller than the diameter of the cells contained in the cell solution. This is not found persuasive as this is drawn to the material operated on by an apparatus which does not structurally define the claimed invention over the prior art. See also MPEP §2115.
With regards to the Corso reference, Applicant argues on the bottom of page 6 to the top of page 7 that the applied reference does not teach the difference thicknesses of the flow paths and does not identify which flow path is which. This is not found persuasive as the thicknesses are shown in Figure 9 of the reference and the flow paths were identified in the rejection.
Therefore, the claims stand rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Weitz et al. (US 2013/0213488 A1) discloses a microfluidic device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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