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
Applicant’s election of Group I, Claims 1-11, in the reply filed on 12/9/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election without traverse of Claims 12-20 in the reply filed on 12/9/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statements dated 9/26/2023; 10/2/2023; and 10/4/2023 have been considered and made of record.
Claim Objections
Withdrawn claims 13, 14, 17, 19 and 20 should be updated to include status identifiers as “(Withdrawn)”.
Claim Rejections - 35 USC § 102
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, 3, 5 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia Sanchez et al. (WO 2013/167185) (Attached PTO-892).
With respect to claim 1, the reference of Garcia Sanchez et al. discloses:
A device (Figs. 1-4, 6 and 11), comprising:
a substrate (substrate)(11);
two interdigitated electrodes (electrodes)(13 and 14) disposed on the substrate; and
a controller (computer (110) and power supply (111)) electronically coupled to the two interdigitated electrodes and configured to apply to the two interdigitated electrodes an electrical stimulation sufficient to induce generation of extracellular vesicles from cells disposed on the substrate without killing the cells (Note: The controller of Garcia Sanchez et al. is configured to apply electrical stimulation sufficient to electroporate cells without killing the cells. As a result, in the absence of further positively recited structure, it is considered to be configured and structurally capable of providing an electrical stimulation sufficient to induce generation of extracellular vesicles from cells disposed on the substrate without killing the cells.).
With respect to claim 3, the device of Garcia Sanchez et al. further comprises a chamber (112) (Figs. 9 and 12) that is coupled to the substrate and that encloses a volume that is exposed to the two interdigitated electrodes.
With respect to claim 5, the device of Garcia Sanchez et al. is structurally capable of providing electrical stimulation is a biphasic electrical stimulation (bipolar)(page 25, lines 12-13) and wherein the biphasic electrical stimulation comprises repeating biphasic waveforms, wherein each biphasic waveform comprises alternating voltage pulses of a negative pulse and a positive pulse, wherein each pulse has a magnitude of between 0.25 V and 1.9 V (page 24, line 25, to page 25, line 13).
With respect to claim 11, the device of Garcia Sanchez et al. is structurally capable of performing electroporation on cells to release extracellular vesicles in response to the electrical stimulation since the device is structured to perform electroporation on cells.
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 2 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Sanchez et al. (WO 2013/167185) (Attached PTO-892).
The reference of Garcia Sanchez et al. has been discussed above with respect to claims 1 and 5.
With respect to claim 2, while the reference of Garcia Sanchez et al. discloses that the electrodes are separated by a distance of 50 µm to 150 µm, the reference does not disclose the widths and lengths required of claim 2. 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 to determine the optimal dimensions of the electrodes through routine experimentation while considering factors such as the types of cells to be used in the system and the purpose of the electroporation process while maintaining the efficiency of the electroporation system.
With respect claims 6-8, while the reference of Garcia Sanchez et al. is silent with respect to the specific electrical stimulation parameters required of claims 6-8, 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 to determine the optimal electrical stimulation parameters through routine experimentation while considering factors such as the types of cells to be used in the system and the purpose of the electroporation process while maintaining the efficiency of the electroporation system.
Claims 4, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Sanchez et al. (WO 2013/167185) (Attached PTO-892) in view of Talebpour et al. (US 2012/0190040).
The reference of Garcia Sanchez et al. has been discussed above with respect to claims 1 and 3.
With respect to claim 4, while the reference of Garcia Sanchez et al. discloses the use of a chamber for holding cells, claim 4 differs by reciting that the chamber includes an let and an outlet.
The reference of Talebpour et al. discloses that it is known in the art to provide an electroporation device/chamber (1) (Fig. 1) with an inlet (10) and an outlet (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 provide the chambers of the reference of Garcia Sanchez et al. with an inlet and outlet for the known and expected result of allowing media to be added and/or removed from the chamber as is conventional in the art.
With respect to claims 9 and 10, the reference of Garcia Sanchez et al. fails to disclose that the device includes an imager and that the substrate is optically transparent.
The reference of Talebpour et al. discloses that it is known in the art to provide an electroporation chamber with an imager system and use transparent materials for the electrodes and substrate to allow the chamber to be imaged within removal of the electrode and substrate (¶[0297]-[0298]).
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 provide the system of the reference of Garcia Sanchez et al. with an imager and use transparent materials for the known and expected result of allowing the cells to be imaged during the electroporation process without the need to remove the electrodes and substrate from the device.
Conclusion
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