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 .
Status of the Claims
The amendment filed 6/1/2026 has been entered. Claims 1-20 remain pending in the application; and claims 6-20 remain withdrawn. Applicant’s amendments to the claims have overcome each objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 4/1/2026.
Specification
The abstract of the disclosure was objected to because it contain. A corrected abstract was received 6/1/2026, and accordingly, the objection to the abstract has been withdrawn.
The disclosure was objected to because of the following informalities: it is recommended that "This application claims benefit to PCT application PCT/EP2022/055345, filed March 3, 2022; which claims benefit to European Patent Application EP 21160739.5, filed March 4, 2021; said applications incorporated herein by reference." be added on page 1 after the Title. A corrected disclosure was received 6/1/2026, and accordingly, the objection to the specification has been withdrawn.
Response to Arguments
Applicant's arguments filed 6/1/2026 have been fully considered but they are not persuasive.
The applicant argues on pp. 9-10 of Remarks that Wikswo et al. fails to disclose all the limitations of the pending claims, as Wikswo et al. discloses electrodes separate from a transwell insert and the claimed invention requires a single, unitary insert that comprises both the electrodes and the treatment space. This is not persuasive, as Wikswo et al. discloses a system comprising an insert (transwell insert) comprising electrodes disposed in the insert (Fig. 6G). The claimed electrodes and insert are not explicitly claimed as one and the same component, but rather, as an insert with electrodes. Therefore, the transwell insert and electrodes disclosed by Wikswo et al. in Fig. 6G read on claim 1 of the instant application.
The applicant argues on p. 10 of Remarks that claim 1 of the instant application provides additional structural limitations that patently distinguish the claimed invention from Wikswo et al., as amended claim 1 recites “an inner space for containing cell material and an opening for removably receiving the insert”. This is not persuasive as Fig. 6G of Wikswo et al. shows an insert disposed within a well with a space containing cells (694) and an opening at the top where the insert may be inserted or removed. This insertable/removable structure is also shown in Fig. 6A and paragraph 0147 of Wikswo et al. which shows transwell inserts that are inserted into wells of a well plate, the wells having openings at the top to allow for the insert to be inserted or removed, and cells to be grown within the insert. Therefore, Wikswo et al. does teach all the structural limitations recited in the claims of the claimed invention.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wikswo et al. (US 2018/0326417 A1) (already of record).
Regarding claim 1, Wikswo et al. discloses an insert for a device for treating cells (paras. 0070, 0152 “transwell insert”), the device having an inner space for containing cell material and an opening for removably receiving the insert (Fig. 6G well 690), the insert comprising: electrodes (Fig. 6G electrodes 696) for emitting electric pulses (para. 0152 “deliver current…AC current”) and an electrical connection (Fig. 6G wires 699), wherein the insert defines a treatment space configured to receive cell material from the inner space of the device (Fig. 6G cell layer 138), wherein the treatment space can be penetrated by the electric pulses emitted by the electrodes and an electric field resulting therefrom (para. 0152 “DC or AC voltage that results as the current passes through the electrical resistance of the cell layer 138”).
Regarding claim 2, Wikswo et al. discloses an insert wherein the insert is a static insert (Fig. 6G).
Regarding claim 3, Wikswo et al. discloses an insert wherein the treatment space is a chamber at one end of the insert and has an opening (Fig. 6G insert has an opening at the top).
Regarding claim 4, Wikswo et al. discloses an insert wherein said treatment space is an open area between the electrodes that are provided at one end of the insert (Fig. 6G treatment space exists where fluid 693, cell layer 138, and electrodes 696 are in the transwell insert).
Regarding claim 5, Wikswo et al. discloses an insert wherein the electrodes are provided in the chamber (Fig. 6G electrodes 696).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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