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 .
Response to Amendment
The amendment filed February 5, 2026 has been entered.
Claims 1-16 remain pending in the application, with claims 1-9 being examined, and claims 10-15 deemed withdrawn.
Applicant has not amended any of the examined claims, and Applicant’s arguments regarding the overcoming the 103 rejections previously set forth in the Non-Final Office Action mailed 11/26/2025 are not persuasive. Based on Applicant’s remarks, the previous prior art rejection has not been modified, but Applicant’s remarks have been addressed in the Response to Arguments section of this instant Office Action.
Claim Rejections - 35 USC § 103
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Borenstein et al. (US Pub. No. 2018/0179485; hereinafter Borenstein; already of record) in view of Zhou et al., Highly uniform in-situ cell electrotransfection of adherent cultures using grouped interdigitated electrodes, April 2020, Bioelectrochemistry, Vol. 132, Pgs. 1-8 (hereinafter Zhou; already of record).
Regarding claim 1, Borenstein discloses an electroporation device ([0006], see Fig. 1). The device comprises:
An electrode pair ([0023]-[0036], [0064]-[0067], see Figs. 6A-6B at electrodes 140a, 140b).
A reaction chamber, the reaction chamber including a first chamber, a second chamber and a porous substrate separating the first chamber from the second chamber, where the reaction chamber is disposed between the electrode pair ([0023]-[0036], [0064]-[0067], see Figs. 6A-6B at fluid receptacle 635 and first channel 150 separated by membrane 145).
A first microfluidic channel configured to deliver a cargo solution from a cargo inlet port to the first chamber ([0023]-[0036], [0064]-[0067], see Figs. 6A-6B at channel where fluid can be transported to first channel 150. The cargo inlet port is not positively recited. See also Claim 9, which shows that the base includes a plurality of fluid ports coupled to the fluid receptacle and the first channel, and Fig. 3).
A second microfluidic channel configured to deliver a cell culture from a cell inlet port to the second chamber ([0023]-[0036], [0064]-[0067], see Figs. 6A-6B at channel where cells can be transported to fluid receptacle 635. The cell inlet port is not positively recited. See also Claim 9, which shows that the base includes a plurality of fluid ports coupled to the fluid receptacle and the first channel, and Fig. 3).
Application of a voltage to an electrode pair permeabilizes membranes of cells adhered to the porous substrate in the reaction chamber disposed between the electrode pair ([0023]-[0036], the electrodes 140 may apply a voltage as a series of pulses to permeabilize the cells positioned on the membrane 145, [0064]-[0067], see Figs. 6A-6B).
Borenstein fails to explicitly disclose:
a plurality of independently controllable or addressable electrode pairs;
a plurality of reaction chambers, each reaction chamber of the plurality of reaction chambers including a first chamber, a second chamber and a porous substrate separating the first chamber from the second chamber, each of the plurality of reaction chambers being disposed between one of the plurality of independently controllable or addressable electrode pairs;
a plurality of first microfluidic channels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers; and
a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers.
Zhou is in the analogous field of electroporation devices (Zhou; Pg. 7 Col. 1 2nd Para., see Fig. 6A). Zhou teaches a plurality of independently controllable or addressable electrode pairs (Zhou; Pg. 7 Col. 1 2nd Para., see Fig. 6A, each GIE unit has an independent switch to control energization of the corresponding GIE unit, Pg. 2 Col. 1 3rd Para., GIEs are grouped interdigitated electrodes). Each of a plurality of reaction chambers are connected to one of the plurality of independently controllable or addressable electrode pairs (Zhou; Pg. 7 Col. 1 2nd Para., see Fig. 6A, where each well of the 12-well plate has its own GIE unit). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Borenstein with the teachings of Zhou to include a plurality of independently controllable or addressable electrode pairs; and a plurality of reaction chambers, each reaction chamber of the plurality of reaction chambers including a first chamber, a second chamber and a porous substrate separating the first chamber from the second chamber, each of the plurality of reaction chambers being disposed between one of the plurality of independently controllable or addressable electrode pairs. The motivation would have been to provide a device where different cells can be transfected with different molecules in parallel, increasing the utility, efficiency, and convenience of transfection in the device (Zhou; Pg. 7 Col. 1 2nd Para., see Fig. 6A).
Modified Borenstein fails to explicitly disclose:
a plurality of first microfluidic channels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers; and
a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide both a plurality of first microfluidic channels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers, and a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers, since a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) and MPEP 2144.04(VI)(B). The motivation would have been that increasing the number of microfluidic channels for delivering cargo solution and cell culture to the device will increase the throughput and versatility of the device.
Note: The instant Claims contain a large amount of functional language (ex: “configured to deliver a cargo solution…”, “configured to deliver a cell culture…”, “configured to expel cargo solution…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 2, modified Borenstein discloses the electroporation device of claim 1. Modified Borenstein further discloses the plurality of first microfluidic channels are further configured to expel cargo solution from the plurality of first chambers to a cargo outlet port, and wherein the plurality of second microfluidic channels are further configured to expel cell culture from the plurality of second chambers to a cell outlet port (Borenstein; [0023]-[0036], [0064]-[0067], see Figs. 6A-6B at channel exiting fluid receptacle 635, and channel exiting first channel 150. Further, see Claim 1 above, where a plurality of first and second microfluidic channels have been taught using case law).
Regarding claim 3, modified Borenstein discloses the electroporation device of claim 1. Modified Borenstein further discloses that application of the voltage causes the cargo solution to pass from the first chamber through the porous substrate and into the cells in the second chamber (the device of modified Borenstein is identical to the instantly claimed device. Therefore, absent any evidence to the contrary, the device of modified Borenstein is capable of causing cargo solution to pass from the first chamber through the porous substrate and into the cells in the second chamber upon application of voltage).
Regarding claim 4, modified Borenstein discloses the electroporation device of claim 1. Modified Borenstein further discloses that each porous substrate is a polymer membrane (Borenstein; [0023]-[0036], particularly at [0033], which states that the membrane 145 may be made of polymers and is semipermeable with pores connecting the upper and lower surfaces of the membrane, [0064]-[0067], see Figs. 6A-6B).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Borenstein in view of Zhou as applied to claims 1-4 above, and further in view of Robitzki et al. (US Pub. No. 2009/0247898; hereinafter Robitzki; already of record).
Regarding claim 5, modified Borenstein discloses the electroporation device of claim 1, and all limitations recited therein.
Modified Borenstein fails to explicitly disclose a removable fixture configured to enclose the electroporation device, the removable fixture including a plurality of electrical ports enabling connection of the plurality of independently controllable or addressable electrode pairs to a voltage generator device or a multimeter device.
Robitzki is in the analogous field of devices for applying electrical fields to tissue samples (Robitzki [0002]-[0003]), and teaches a removable fixture configured to enclose a device, the removable fixture including a plurality of electrical ports enabling connection of the plurality of independently controllable or addressable electrode pairs to a voltage generator device or a multimeter device (Robitzki; [0076], [0140]-[0141], the top electrodes are individually or simultaneously addressable by a multiplexer, [0169], see Figs. 2-4 at lid 3, which has a multiplexer board 8 integrated inside). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of modified Borenstein with the teachings of Robitzki to include a removable fixture configured to enclose the electroporation device, the removable fixture including a plurality of electrical ports enabling connection of the plurality of independently controllable or addressable electrode pairs to a voltage generator device or a multimeter device, as Robitzki teaches that a plurality of electrical ports can be used to individually or simultaneously address electrodes as desired (Robitzki; [0076], [0140]-[0141], [0169], see Figs. 2-4). Further, enclosing the electroporation device will protect the contents of the device from contamination.
Allowable Subject Matter
Claims 6-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The claims would be allowable for the same reasons stated in the Allowable Subject Matter section of the Non-Final Office Action mailed 11/26/2025.
Claims 7-9 would be allowable for depending on claim 6, an allowable claim.
Response to Arguments
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 6-9 of their Remarks that Borenstein does not teach a plurality of first microchannels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers, and a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers. The Applicant points out that Borenstein only teaches a single chamber where both cells and cargo are introduced, that Borenstein teaches that cells and cargo are introduced into the receptacles 135/165 via micropipetters, and that in Fig. 6A of Borenstein, the cells and cargo are introduced via a first fluid flow A, and that the second fluid flow B includes neither cells nor cargo. The Examiner respectfully disagrees and asserts that Borenstein, as modified by Zhou and in combination with case law, does in fact teach a plurality of first microchannels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers, and a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers. Firstly, the use of micropipetters to introduce cells and cargo into the receptacles is merely taught by Borenstein as exemplary, and Fig. 6A clearly shows multiple microchannels entering the system 600A, as corroborated by at least Claim 9 and Fig. 3 of Borenstein, which describes microchannels delivering fluid to a first channel, and fluid ports coupled to the fluid receptacle and first channel. Further, the system 600A of Borenstein can be considered under broadest reasonable interpretation to have a first chamber and a second chamber, each separated from each other by the membrane 145. Finally, although Borenstein teaches that the cells and cargo are introduced into the receptacle via Fluid Flow B in Fig. 6A, the Fluid Flow A is capable of delivering either of a cargo solution or a cell culture into its corresponding chamber. The limitation “a plurality of first microchannels configured to deliver a cargo solution from a cargo inlet port to the plurality of first chambers, and a plurality of second microfluidic channels configured to deliver a cell culture from a cell inlet port to the plurality of second chambers” uses functional language, ex. “configured to deliver a cargo solution…”, “configured to deliver a cell culture…”, and functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this case, as Borenstein teaches two microfluidic channels, each channel flowing to a corresponding chamber in the system which are separated by a membrane, Borenstein teaches a system capable of performing the claimed function. See MPEP 2114. From there, modifying the device of Borenstein to include a plurality of first microfluidic channels and a plurality of second microfluidic channels can be addressed using duplication of parts case law. For a more detailed explanation, please see the rejection of claim 1 in the Claim Rejections-35 USC 103 section of this instant Office Action.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JOHN MCGUIRK/Examiner, Art Unit 1798