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.
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) (PTO-892 dated 4/8/2026).
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 the claim language “directly in contact with an interfacing surface of at least one of the two interdigitated electrodes disposed on the substrate without killing the cells”, the structure of Garcia Sanchez et al. is considered to be structurally capable of meeting this claim limitation for the following reason:
While the reference of Garcia Sanchez et al. does not use the disclosed device with the cells in direct contact with the substrate and electrodes, the disclosed structure of the device could be used in this manner. Note: The manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. The current claim language is drawn to an intended use of the apparatus rather than a structural difference (MPEP 2114, II).
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Sanchez et al. (WO 2013/167185) (PTO-892 dated 4/8/2026).
The reference of Garcia Sanchez et al. has been discussed above with respect to claims 1 and 5.
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) (PTO-892 dated 4/8/2026) in view of Lin et al. (Sensors and Actuators) (Attached PTO-892) and Talebpour et al. (US 2012/0190040) (PTO-892 dated 4/8/2026).
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 a culture well situated on top of the two interdigitated electrodes.
The reference of Lin et al. discloses that when electroporating cells, a cell-accommodation cavity with thin-film interdigitated electrodes can be used by forming a culture well situated on top of the two interdigitated electrodes (Fig. 1 and “2.1 Design and microfabrication of electroporation microchips”).
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 alternatively form the electroporation cavity of the reference of Garcia Sanchez et al. using the chamber forming technique disclosed by the reference of Lin et al. for the known and expected result of providing an alternative means recognized in the art while achieving the same result, electroporation of adhered cells.
Additionally, 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 inlet 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.
Both the references of Lin et al. and 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 (Fig. 1 of Lin et al. and ¶[0297]-[0298] of Talebpour et al.).
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.
Allowable Subject Matter
Claim 2 is 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:
Claim 2 would be allowable because the prior art of record fails to teach or fairly suggest a device, in the claimed environment or scope of claim, that includes interdigitated electrodes disposed on a substrate and coupled to a controller as required of claim 1, wherein each of the two interdigitated electrodes comprises a respective plurality of conductive extensions, wherein each of the conductive extensions has a width of between 13 µm and 17 µm and a length of greater than 200 µm and is separated from a conductive extension of the opposite electrode by a distance of at least 10 µm. While the closest prior art references of Sanchez et al. (WO 2013/167185) (PTO-892 dated 4/8/2026) and Lin et al. (Sensors and Actuators) (Attached PTO-892) disclose devices that include interdigitated electrodes disposed on a substrate and coupled to a controller as required of claim 1 and wherein each of the two interdigitated electrodes comprises a respective plurality of conductive extensions, the references fail to teach or fairly suggest that the conductive extensions of the electrodes have dimensions within the scale required of claim 2. One of ordinary skill in the art would not have been motivated to employ conductive extensions with the dimensions as required of claim 2 for the reasons articulated on pages 8-10 of Applicants’ response dated 6/1/2026.
Response to Arguments
Response to the Claim Objections
The objection to claims 13, 14, 17, 19 and 20 has been withdrawn in view of the amendments to the claims and related comments on page 6 of the response dated 6/1/2026.
Response to the 35 USC 102 and 103 Rejections
a. Claim 1
With respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Garcia Sanchez et al. (WO 2013/167185), Applicants argue that the rejection is improper for the following reasons (pages 6-8 of the Applicants’ response dated 6/1/2026):
Garcia Sanchez does not disclose or suggest "a controller 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 directly in contact with an interfacing surface of at least one of the two interdigitated electrodes disposed on the substrate without killing the cells," as is recited in amended claim 1 (emphasis added), nor is the device of Garcia Sanchez "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," as alleged by the Examiner.
In response, the rejection has been maintained because the newly recited claim limitation fails to further limit the structure of the claimed device over that of the reference of Garcia Sanchez et al. As discussed in the prior art rejection of claim 1, while the reference of Garcia Sanchez et al. does not use the disclosed device with the cells in direct contact with the substrate and electrodes, the disclosed structure of the device could be used in this manner. Note: The manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. The current claim language is drawn to an intended use of the apparatus rather than a structural difference (MPEP 2114, II). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
b. Claims 2 and 6-8
With respect to claim 2, the rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Garcia Sanchez et al. (WO 2013/167185) has been withdrawn in view of Applicants comments directed to claim 2 on pages 8-10 of the response dated 6/1/2026.
With respect to claims 6-8, the rejections have been maintained for the following reasons:
The reference of Garcia Sanchez et al. clearly discloses that the controller 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). Page 24, lines 25-31, of the reference of Garcia Sanchez et al. clearly discloses that the controller is capable of providing the operating regime ranges within the ranges required of claims 6-8. As a result, the controller is structurally capable of providing the required operating conditions and one of ordinary skill in the art would be capable of determining the optimal operating conditions based on the specific of the electroporation process to be performed as evidenced by the disclose in the reference of Garcia Sanchez et al. at page 24, line 25, to page 25, line 13.
c. Claims 4, 9 and 10
With respect to the rejection of claims 4, 9 and 10 over Garcia Sanchez et al. (WO 2013/167185) in view of Talebpour et al. (US 2012/0190040), Applicants are of the position, that the reference of Talebpour et al. does not cure the deficiencies previously discussed regarding the reference of Garcia Sanchez et al. (pages 10-11 of the response dated 6/1/2026).
In response, for reasons already argued with respect to claim 1, the Examiner is of the position that the reference of Garcia Sanchez et al. meets the limitations required of claim 1. The reference of Talebpour et al. was cited to address the additional limitations required of claim 4. Additionally note, the newly cited reference of Lin et al. has been added to the rejection of claim 4 to address the newly recited limitation regarding “a culture well is situated on top of the two interdigitated electrodes”.
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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