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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 11, 2026 has been entered.
Claim Rejections - 35 USC § 102/103
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.
Claims 1-5, 8, 10-13, 16-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nishiyama et al (US20060040374A1 published 02/23/2006; hereinafter Nishiyama) as evidence by Verkouteren et al (Inkjet Metrology II: Resolved Effects of Ejection Frequency, Fluidic Pressure, and Droplet Number on Reproducible Drop-on-Demand Dispensing; published 08/02/2011) or, in the alternative, under 35 U.S.C. 103 as obvious over Nishiyama as evidence by Verkouteren in view of Xu et al (US20150299730A1 published 10/22/2015; hereinafter Xu).
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Regarding claim 1, Nishiyama teaches a compound introduction apparatus for introducing a compound into a cell, comprising:
a cell suspension storage part (a recovery part – paragraph 18) containing a cell suspension containing the cell and the compound (a recovery part from a predetermined position at which a predetermined material is injected into each cell in a cell suspension – paragraph 18);
a supply flow channel (a channel 131a – Fig. 2A) for supplying the cell suspension containing the cell and the compound (the channel 131a holding the cells, genes, and medication solution – Fig. 2A and paragraph 59);
an introduction unit (an injector 140 comprising a capillary 143 and a drive unit 135 – paragraph 57 and Fig. 1) that includes an energy generation element (a drive unit 135 such as a piezoelectric element – paragraph 56 and Figs. 1, 4C) and is configured to introduce the compound into the cell by applying at least mechanical energy generated by the energy generation element (the drive unit 135 is capable of providing mechanical energy via gates 133a/133b and the capillary 143 to inject genes and medication solutions into the cells – Fig. 2A and paragraph 59) ; and
an ejection port (a space between the gates 133a/133b – Fig. 4B) for ejecting the cell suspension containing the cell in which the compound has been introduced (the gate 133a/133b allows and prohibits the feeding of the cell C along the channel 131a – Fig. 4B and paragraph 55),
wherein a height of the supply flow channel relative to a flow direction of the cell suspension flowing through the supply flow channel is more than 1.0 times a diameter of the cell to less than 2.0 times the diameter of the cell (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45), and a width of the supply flow channel relative to the flow direction is more than 1.0 times the diameter of the cell to less than 2.0 times the diameter of the cell (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45), and
wherein a diameter of the ejection port is more than 1.0 times the diameter of the cell to less than 2.0 times the diameter of the cell (the space between the gate 133a/133b is the same dimension as the channel 131a when the gate 133a/133b is opened; therefore, the space has a width and height of 30 to 50 µm while the cell C has a diameter of 15 to 25 µm – Fig. 4B and paragraph 56), and
wherein the energy generation element (the injector 140 comprising the drive unit 135 such as a piezoelectric element – paragraph 56 and Figs. 1, 4C) is a heating generation element (the drive unit 135 capable of generating heat through friction by moving the gate 133a/133b – paragraph 56 and Fig. 4C) or a piezoelectric element (a drive unit 135 such as a piezoelectric element – paragraph 56),
and wherein the supply flow channel is configured to supply the cell suspension from the cell suspension storage part to the ejection port (the channel 131a supplies cells from the recovery part to space between the gates 133a/133b – Fig. 2B and paragraph 14).
In the alternative, if the applicant find that Nishiyama fails to disclose introduce the compound into the cell by applying at least mechanical energy generated by the energy generation element.
Xu teaches a method using thermal inkjets (paragraph 54) for transfecting cells comprising introduce the compound into the cell by applying at least mechanical energy (shear stress applied to the cells – Fig 1 and paragraph 36) generated by the energy generation element (a heating element vaporizes ink to create a bubble – Fig. 1 and paragraph 50). Xu teaches to use the inkjet and z-axis module for higher cell viability after transfection (paragraph 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the transfection system, as taught by Nishiyama, with the inkjet, taught by Xu, to gain higher cell viability after transfection. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Nishiyama and Xu teach cell transfection systems.
Regarding claim 2, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the heating generation element or the piezoelectric element generates energy in a height direction of the supply flow channel (the injector 140 comprising the drive unit 135 capable of generating heat in a height direction of the channel 131a through friction by moving the gate 133a/133b – paragraph 56 and Fig. 4C).
Regarding claim 3, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the introduction unit is the heat generation element (the injector 140 comprising the drive unit 135 capable of generating heat through friction by moving the gate 133a/133b – paragraph 56 and Fig. 4C).
Regarding claim 4, Nishiyama teaches the compound introduction apparatus according to claim 3, further comprising a processing chamber (the injector 140 comprising grooves 137 holding the gate 133a/133b – Fig. 4B) in which the heat generation element is arranged (the drive unit 135 is capable of generating heat through friction by moving the gate 133a/133b in the grooves 137 – paragraph 56 and Fig. 4C).
Regarding claim 5, Nishiyama teaches the compound introduction apparatus according to claim 4, wherein the ejection port is arranged directly below the heat generation element and the processing chamber (the space between the gate 133a/133b is located directly below the grooves 137 when the channel 131A is arranged vertically – Fig. 4B).
Regarding claim 8, Nishiyama teaches the compound introduction apparatus according to claim 3, wherein a time for which the heat generation element generates heat is 0.1 µs to 5 µs (the piezoelectric drive unit 135 is capable of generating heat for 0.1 µs to 5 µs – paragraph 56 and Fig. 4C) (As evidenced by Verkouteren piezoelectric transducers or PZT are capable of frequencies between 1-10,000 Hz – Verkouteren Fig. 3).
Regarding claim 10, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the diameter of the cell is 1 µm to 100 µm (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45).
Regarding claim 11, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the height and the width of the supply flow channel are each more than 1 µm and less than 200 µm (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45).
Regarding claim 12, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the cell is a eukaryotic cell (biogenetic cells, such as leukocytes' antibody generation – paragraph 2) (the examiner points out that leukocytes are eukaryotic cells).
Regarding claim 13, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the height of the supply flow channel is a length (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45) thereof in a direction of gravity (the height of the channel 131 is in the direction of gravity – Fig. 2A).
Regarding claim 16, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the height of the supply flow channel relative to the flow direction is more than 1 µm to less than 200 µm (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45), and the width of the supply flow channel relative to the flow direction is 1 µm to less than 200 µm (the channel 131 has a width and height of 30 to 50 µm and the cell C has a diameter of 15 to 25 µm – Fig. 2A and paragraph 45).
Regarding claim 17, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the diameter of the ejection port is 15 µm to 23 µm (the space between the gate 133a/133b is 5 to 10 µm when the 133a/133b are closed – paragraph 56) (the space between the gate 133a/133b is the same dimension as the channel 131a, 30 to 50 µm, when the gate 133a/133b is fully opened; therefore, there is a period of time while the gates are opening such that the space between the gates is between 15 µm to 23 µm – Fig. 4B and paragraph 56).
Regarding claim 18, Nishiyama teaches the compound introduction apparatus according to claim 1, wherein the cell suspension storage part is detachably configured with respect to a main body of the compound introduction apparatus (the recovery part in the first feeding unit 110 is capable of being detached from the injector 140 by disconnecting a pipeline 102 – Fig. 1 and paragraph 41).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiyama et al (US20060040374A1 published 02/23/2006; hereinafter Nishiyama) in view of Xu et al (US20150299730A1 published 10/22/2015; hereinafter Xu).
Regarding claim 6, Nishiyama teaches the compound introduction apparatus according to claim 4, wherein in a case where the heat generation element generates heat (the drive unit 135 capable of generating heat through friction by moving the gate 133a/133b in the grooves 137 – paragraph 56 and Fig. 4C).
However, Nishiyama does not teach a stress resulting from bubble generation caused by the heat generation is applied to the cell suspension inside the processing chamber.
Xu teaches a method using thermal inkjets (paragraph 54) for transfecting cells comprising a stress resulting from bubble generation caused by the heat generation (a heating element vaporizes ink to create a bubble – Fig. 1 and paragraph 50) is applied to the cell suspension inside the processing chamber (shear stress applied to the cells – Fig 1 and paragraph 36). Xu teaches to use the inkjet and z-axis module for higher cell viability after transfection (paragraph 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the transfection system, as taught by Nishiyama, with the inkjet, taught by Xu, to gain higher cell viability after transfection. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Nishiyama and Xu teach cell transfection systems.
Regarding claim 7, Nishiyama, modified by Xu, teaches the compound introduction apparatus according to claim 6, wherein the stress is exerted for 1µs to 10µs (shear stress applied for a limited period of time of 0.5 to 10 microseconds – Xu paragraph 36) and consequently a droplet of the cell suspension is discharged from the ejection port at a speed of 0.5 m/s to 30 m/s (Nishiyama, modified by Xu, teach a thermal inkjet and is capable of discharging a droplet of cells at a speed of 0.5 m/s to 30 m/s – Xu paragraph 54) (As evidenced by Verkouteren inkjet produce ejections velocities between 0.5-8 m/s – Verkouteren Fig. 3).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nishiyama et al (US20060040374A1 published 02/23/2006; hereinafter Nishiyama).
Regarding claim 9, Nishiyama (Fig. 4B) teaches the compound introduction apparatus according to claim 1.
However, Nishiyama (Fig. 4B) does not teach wherein the diameter of the ejection port is larger than the height of the supply flow channel.
Nishiyama (Fig. 11) teaches another embodiment wherein the diameter of the ejection port is larger than the height of the supply flow channel (the nozzle 182 to simultaneously supply a predetermined number of cells – paragraph 71) (the nozzle 182 is wider that the pipeline 177b because the pipeline 177b is not wide enough to simultaneously supply multiple cells – Fig. 11). Nishiyama (Fig. 11) teaches to use a nozzle to move and store the cells in a treatable unit to confirm the cloning of the cell and effect expressions of introduced gene and medication (paragraph 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Nishiyama (Fig. 4B), with a nozzle to move and store the cells, taught by Nishiyama (Fig. 11), to confirm the cloning of the cell and effect expressions of introduced gene and medication. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Nishiyama teaches multiple embodiments of the same invention.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Point 1: The applicant argues that “the cell suspension storage part is a part in which a cell is stored before a compound is introduced” and is not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the cell suspension storage part is a part in which a cell is stored before a compound is introduced”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Point 2: The applicant argues that “Nishiyama does not teach the introduction unit of the present invention” and is not persuasive.
The examiner points out that the limitation “introduce the compound into the cell by applying at least mechanical energy generated by the energy generation element” is a functional limitation of the energy generation element, per MPEP2114II 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” because Nishiyama teaches an injector 140 comprising a drive unit 135 that read on all the structural limitations of the claim.
In the alternative, if the applicant find that Nishiyama fails to disclose introduce the compound into the cell by applying at least mechanical energy generated by the energy generation element, Xu teaches introducing the compound into the cell by applying at least mechanical energy with a heating element that imparts shear stress to cells (Fig 1 and paragraph 36).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20050265899A1 – a piezo ink-jet system type liquid transfer apparatus having a vibrator plate stacked with a plate-shaped piezoelectric element to apply pressure on the liquid (paragraph 37)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798