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 .
Response to Amendment
The Amendment filed on 12/12/2025 has been entered. Claims 1, 3, 18, 21, 23, 24, 26, 28, 39, 34-37, 39, 43, 48 and 52-55 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the non-final Office Action mailed 10/2/2025.
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.
Claim(s) 1, 3, 18, 21, 23, 24, 28, 29 and 52-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2017/0283761, hereinafter Corso in view of 2006/0121446, hereinafter Abassi, United States Application Publication No. 2020/0330994, hereinafter Craig and United States Application Publication No. 2014/0004501, Talebpour.
Regarding claims 1, 3 and 52, Corso teaches a microfluidic flow-based system (figure 5) for electroporation, comprising: at least one flow device (figure 1), comprising: at least one planar flow channel (the channel formed by item 106); at least one pair of electrodes (items 101 and 102); at least one first port (items 103-105); and at least one second port (item 108), at least one electrical control module (item 606) that connects to the at least one pair of electrodes (figure 5 and paragraph [0059]); at least one fluid delivery system that link to the at least one flow device at the at least one first port (the pump and tubing as described in paragraphs [0058] and [0061]).
Corso fails to teach the at least one electrical control module configured to generate a time-dependent electrical field across the at least one planar flow channel, the time-dependent electric field having a polarity configured to alternate as a function of time, and a waveform of the time-dependent electric field comprising a series of alternating positive and negative peaks.
Abassi teaches the use of an electrical control module that connects to electrodes for electroporation in which a bi-polarity square wave is utilized along with voltage and frequencies (Abassi, paragraph [0127]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., utilizing a bi-polar square wave for electroporation), and that in combination, each element merely would have performed the same function as it did separately (i.e., electroporation), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the electrical control module of reference Corso with the bi-polar square wave signal from an electrical control module of reference Abassi, since the result would have been predictable. Further, the at least one electrical control module and the at least one fluid delivery system are each configured to vary at least one suitable electroporation parameter independently (Corso, paragraphs [0058] and [0061] and Abassi, paragraph [0127]).
Corso and Abassi fail to teach a multi-well module that links to the at least one flow device at the at least one second port.
Craig teaches a method for performing biological reactions including electroporation (Craig, paragraph [0102]) with the substrate is mounted vertically with the output channel directed downwards towards a multi-well or microtiter plate and moves the instrument moves the substrate to direct the output channel into a selected well (Craig, paragraph [0160]) so that the samples can be stored and retrieved for further processing or analysis or subsequent use (Craig, paragraph [0151]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a multi-well module that links to the at least one second port and an instrument that moves the flow device around because it would allow for the directed output of the flow device into selected wells (Craig, paragraph [0160]) so that the samples can be stored and retrieved for further processing or analysis or subsequent use (Craig, paragraph [0151]).
Corso, Abassi and Craig fail to teach the at least one planar flow channel has an aspect ratio of between about 10:1 to 800:1, the aspect ratio being defined as a ratio of a width of the at least one planar flow channel and a height of the at least one planar flow channel and a width of the at least one planar flow channel is about 0.1-7 mm.
Talebpour teaches an electroporation device in which the channel height is between 50-500 µm so that effective electrical treatment may be obtained and a width between 1 and 10 mm so that the desired channel volume and flow can be achieve (Talebpour paragraph [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum width and aspect ratio to a range of 0.1-7 mm and 10:1 to 800:1, respectively, which would allow for the effective electrical treatment and desired channel volume and flow to be achieved (Talebpour, paragraph [0107]) (MPEP § 2144.05 (II)).
Regarding claim 18, modified Corso teaches further comprising a robotic module that moves the at least one flow device relative to the multi-well module (see supra).
Regarding claim 21, modified Corso teaches wherein the at least one electrical control module provides the waveform comprising a voltage that has a bipolar square wave (see supra).
Regarding claim 23, modified Corso teaches the waveform is a square waveform (see supra) having a voltage amplitude of at least 1-300 V and a frequency of 1 Hz to 1 kHz (Abassi, paragraph [0127]).
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the voltage and frequency in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 24, modified Corso teaches the square waveform (see supra) further comprises a direct current component (Abassi, paragraph [0124]) of 1-100 V (Abassi, paragraph [0127]).
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the voltage in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 28, Corso teaches further comprising: a flow sensor (paragraph [0062]); a flow-rate control module (item 601); a temperature control module (paragraph [0058]); (d) a fluid interface that couples the at least one fluid delivery system to the at least one flow device (paragraph [0061]); a cell processing module (paragraph [0072]); an electrical (paragraph [0041]) or optical monitoring module (item 605) coupled to the at least one flow device (figure 5) ; or any combination of two or more (see supra).
Regarding claim 29, Corso teaches wherein the cell processing module allows cell analysis (paragraph [0072]).
Regarding claim 53, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Corso, Abassi, Craig and Talebpour and the apparatus of modified Corso is capable of having the multi-well module conduct parallel processing of multiple samples. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Corso (see MPEP §2114).
Regarding claim 54, Corso, Abassi, Craig and Talebpour, as described above, teaches all limitations of claim 1; however, they fail to teach the time-dependent electric field is generated by a voltage, wherein the voltage comprises a short-duration, high-amplitude segment followed by a long-duration, low-amplitude segment.
Abassi further teaches a bi-polar square wave can be combined with an exponential decay wave for use with electroporation (Abassi, paragraph [0127]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., utilizing a bi-polar square wave combined with an exponential decay wave for electroporation), and that in combination, each element merely would have performed the same function as it did separately (i.e., electroporation), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the electrical control module of reference Corso with the bi-polar square wave combined with an exponential decay wave signal from an electrical control module of reference Abassi, since the result would have been predictable.
Regarding claim 55, Corso, Abassi, Craig and Talebpour, as described above, teaches all limitations of claim 1; however, they fail to teach the time-dependent electric field is generated by a voltage, wherein the voltage comprises a short-duration, high-amplitude segment followed by a long-duration, low-amplitude negative segment.
Abassi further teaches a bi-polar square wave can be combined with an exponential decay wave for use with electroporation (Abassi, paragraph [0127]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., utilizing a bi-polar square wave combined with an exponential decay wave for electroporation), and that in combination, each element merely would have performed the same function as it did separately (i.e., electroporation), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the electrical control module of reference Corso with the bi-polar square wave combined with an exponential decay wave signal from an electrical control module of reference Abassi, since the result would have been predictable.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corso, Abassi, Craig and Talebpour as applied to claim 1 above, and further in view of United States Application Publication No. 2013/0203086, hereinafter Achyuta.
Regarding claim 26, Corso, Abassi, Craig and Talebpour teach wherein the at least one flow device comprises at least two first ports of the at least one first port (items 103-105) and a fluid delivery system (the pump and tubing as described in paragraphs [0058] and [0061]) and the flow rate of each of the fluid streams can be controlled (paragraph [0030]).
Corso, Abassi, Craig and Talebpour fail to teach at least two fluid delivery systems, wherein each fluid delivery system is connected to a different first port.
Achyuta teaches a device with a plurality of fluid pumps so that different flow rates can occur through different channels (Achyuta, paragraph [0117]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized at least two fluid delivery systems because it would allow for the control of different flow rates through each of the inputs (Achyuta, paragraph [0117]).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corso, Abassi, Craig and Talebpour as applied to claim 28 above, and further in view of United States Application Publication No. 2020/0131500, hereinafter Garcia.
Regarding claim 34, Corso teaches a cell reservoir (item 600) upstream of the cell processing module (figure 5).
Corso, Abassi, Craig and Talebpour fail to teach the cell reservoir is an apheresis bag.
Garcia teaches an electroporation device which utilizes a sample bag as the first reservoir connected to the inlet of the device (Garcia, paragraph [0013]).
Examiner further finds that the prior art contained a device/method/product (i.e., an apheresis bag) which differed from the claimed device by the substitution of component(s) (i.e., a cell reservoir) with other component(s) (i.e., an apheresis bag), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a cell reservoir with an apheresis bag), and the results of the substitution (i.e., holing the cells) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute a cell reservoir of reference Corso with an apheresis bag of reference Garcia, since the result would have been predictable.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 12/12/2025, with respect to the rejection(s) of claim(s) 1-3 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Corso, Abassi, Craig and Talebpour.
Conclusion
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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796