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 .
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.
Election/Restrictions
Claims 26-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/16/2025.
Information Disclosure Statement
The information disclosure statements dated 7/9/2025 and 9/25/2025 have been considered and made of record.
Claim Rejections - 35 USC § 103
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.
Claims 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hogan et al. (US 2018/0051243) in view of Caiafa et al. (US 10,421,956).
With respect to claim 17, the reference of Hogan et al. discloses:
A device (Figs. 7A-7C), comprising a unit for generating and emitting electric pulses (capacitor)(7020), and one treatment space (electroporation position)(7130) that can be penetrated by the emitted electric pulses and an electric field resulting therefrom, wherein the device further comprises a unit (carousel)(7080) which can be moved into and out of said treatment space (7130) such that a cell material provided within a compartment of said unit, or provided in a container (cuvette)(7040) on or in said unit, can be moved into and out of said treatment space, and wherein said treatment space (7130) is provided between two electrodes (7150 and 7180) or plates of a capacitor parallel to each other.
Claim 17 differs by reciting that the treatment space only includes two electrodes or plates of a capacitor and the unit which can be moved into and out of the treatment space does not exhibit electrodes.
The reference of Caiafa et al. discloses that it is known in the art to generate and emit electric pulses with respect to a container holding a cell material using a container (Fig. 9) (cuvette)(152) having electrodes (156A and 156B) to provide a conductive path between the container cavity (104) which is similar to the container (7040) of the reference of Hogan et al. The reference of Caiafa et al. also alternatively discloses that it is known in the art to generate and emit pulses with respect to a container holding a cell material using a container (Fig. 10B) (cuvette)(122) without electrodes (col. 6, line 62, to col. 7, line 11).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a capacitively coupled sample holder, such as that disclosed in Fig. 10B of the reference of Hogan et al., in place of the sample holder of the primary reference for the known and expected result of providing an alternative means recognized in the art for holding a sample and generating and emitting electric pulses to the sample held within the sample container while reducing or simplifying the complexity of the sample holder (col. 5, lines 54-57). The structure resulting from the combination of the references would encompass a treatment space that only includes two electrodes or plates of a capacitor and the unit which can be moved into and out of the treatment space does not exhibit electrodes.
With respect to claims 18, 19 and 21, the reference of Hogan discloses the unit includes a motor (7090) and plate or conveying device or body (carousel)(7080) for holding at least one container or compartment (cuvette)(7040).
With respect to claims 20 and 22, the reference of Hogan discloses 8 compartments or containers (Fig. 7C).
With respect to claims 23 and 24, the reference of Hogan discloses the use of ports (7060 and 7070) for filling and emptying the cuvettes/compartments/containers using automated syringes (¶[0088]-[0090]) which are considered to be functional equivalents of the filling and emptying structures of the instant disclosure.
With respect to claim 25, while the reference of Hogan et al. discloses a unit for generating and emitting electric pulses that includes the use of two electrodes (7150 and 7180) or plates, the reference is silent with respect to the operating conditions recited in claim 25.
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art, through routine experimentation, to optimize the electroporation parameters within the device based merely on the specifics of the cells to be treated, the volumes of the samples and/or the containers, etc. while maintaining the electroporation efficiency of the device.
Response to Arguments
35 USC 112
The rejections of claims 18-22 and 25 under 35 USC 112(b) have been withdrawn in view of the amendments to claims 18, 19, 21 and 25 and related comments on page 6 of Applicants’ response dated 8/12/2025.
35 USC 102 and 103
The rejection of claims 18-25 under 35 USC 102 and 103 have been withdrawn in view of the amendments to claim 18 and related comments on pages 6-9 of Applicants’ response dated 8/12/2025. Additionally, note the structure encompassed by the combination of the references of Hogan et al. (US 2018/0051243) in view of Caiafa et al. (US 10,421,956) would be structurally capable of producing any number of types of electric pulses as discussed by Applicants.
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 WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (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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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
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