DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 April 2026 has been entered.
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.
Claims 1-5, 8-15 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Dominguez (US 20190136224) in view of Ziv “Micro-electroporation of mesenchymal stem cells with alternating electrical current pulses”.
With respect to claims 1 and 23, Garcia Dominguez discloses an electroporation device and kit comprising at least two conductive elements having a hollow tubular structure. An insulating structure defining a channel of constant diameter is configured to fluidically couple the two conductive elements to define an electroporation flow path. This is described in paragraph [0149], which states that the conductive elements are 16-guage stainless-steel dispensing needle electrodes. Paragraph [0150] teaches that the insulating structure is made from PDMS and glass materials, which are understood to have insulating properties. At least Fig. 23C shows an embodiment in which the channel has a constant diameter. See also paragraph [0146], which states that, in the Fig. 23C embodiment, “[t]he straight microchannel (FIG. 23C) is 50 μm in width, with a constant cross-sectional area along its entire 3 mm length”.
PNG
media_image1.png
262
511
media_image1.png
Greyscale
It is unclear, however, if Garcia Dominguez shows that the two conductive elements are inserted along an axial direction of the insulating structure.
Ziv discloses an electroporation device comprising at least two conductive elements having a hollow, tubular structure. The conductive elements are fluidically coupled to an insulating structure along an axial direction of the insulating structure. The insulating structure additionally includes a channel. This is shown in Figs. 1 and 3b and described in the materials and methods section spanning pages 96-99. Ziv teaches that the insulating structure is made from PDMS, which is understood to have insulating properties.
PNG
media_image2.png
428
806
media_image2.png
Greyscale
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Garcia Dominguez conductive elements are inserted into the insulating structure so that they are oriented along an axial direction of the insulating structure. Ziv shows that this is a “simple and inexpensive way to produce a micro-electroporation channel” suitable for the treatment of target cells. Ziv indicates that electrode needles operate in a similar manner and may be used to generate fluid flow and produce an electric field in a similar way regardless of whether they are parallel or orthogonal to the axial direction of the insulating structure.
With respect to claims 2 and 3, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez teaches in paragraph [0149] that the conductive elements are 16-guage stainless-steel dispensing needle electrodes, which reads on a cannula. Furthermore, the conductive element needles are described as being operable with a syringe pump.
With respect to claim 4, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez further states that channel is a tube formed using PDMS, which is a polymer.
With respect to claim 5, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez shows in Fig. 27 that the two conductive elements are inserts at opposing ends of the channel.
With respect to claim 8, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez additionally shows in Fig. 23C that the length of the channel is approximately 4 mm to define a gap between the two oppositely-disposed conductive elements.
With respect to claims 9-11, Garcia Dominguez and Ziv discloses the combination as described above. Paragraphs [0019] and [0123] of Garcia Dominguez states that a fluid pump is used to deliver fluid through the channel at a flow rate between 0.5 to 5 mL/min. Paragraph [0120] states that a controller (Figure 14:1460) is used to regulate the flow rate of the pump based on a desired residence time.
With respect to claims 12-14, Garcia Dominguez and Ziv discloses the combination as described above. Paragraphs [0016] and [0017] of Garcia Dominguez teach that a power supply is used to generate an electric field within the channel of about 0.5 kV/cm to about 12.5 kV/cm. Garcia Dominguez teaches that the power supply is also in communication with the controller (Figure 14:1460).
With respect to claim 15, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez further teaches in paragraph [0110] that channel diameter and distance are considered when applying a particular voltage.
With respect to claim 17, Garcia Dominguez and Ziv discloses the combination as described above. Although there appears to be a typo in the publication (“m” instead of the intended “µm”), Garcia Dominguez is understood to teach a channel diameter of about 0.5 mm to about 5 mm in paragraph [0127].
With respect to claims 18 and 19, Garcia Dominguez and Ziv discloses the combination as described above. The insulating structure and conductive elements taught by Garcia Dominguez are both considered to be disposable.
With respect to claims 20 and 21, Garcia Dominguez and Ziv discloses the combination as described above. Fluid flow may pass through the Garcia Dominguez channel at a wide variety of velocities, including between about 0.1 m/s to about 5 m/s. See, for example, paragraph [0011]. Furthermore, it is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to 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. Here, the designation of a desired flow rate relates to how the device is intended to be used, as opposed to further limiting the device structure.
With respect to claim 22, Garcia Dominguez and Ziv discloses the combination as described above. Garcia Dominguez teaches a corresponding method of fabricating the electroporation device in which the conductive elements are inserted at opposing ends of the insulating structure.
Claims 6, 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Dominguez (US 20190136224) in view of Ziv “Micro-electroporation of mesenchymal stem cells with alternating electrical current pulses” as applied to claims 5 and 12, and further in view of Kodama (US 20220396755) and Gelfand (US 20140206030).
With respect to claims 6 and 7, Garcia Dominguez and Ziv discloses the combination as described above, however do not expressly teach the provision of markings and/or stops to control an insertion distance of the conductive elements.
Kodama discloses a cell treatment system in which a cannula/needle (Figure 10:31) is inserted into a cell treatment chamber. The insertion distance of the cannula/needle is limited using stops (Figure 10:24) built into the chamber. This is taught in paragraphs [0124]-[0126] (“A plurality of engaged portions 24 may be formed in a single pretreatment recess 21, or the engaged portions 24 may have a multi-stage structure”).
Gelfand discloses a biological specimen treatment system in which a cannula/needle is inserted into a cell treatment chamber. The insertion distance of the cannula/needle is regulated using detectable markings (Figure 3B:165) disposed on a wall of the chamber. This is taught in paragraphs [0043]-[0046].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Garcia Dominguez insulating structure includes markings and/or stops configured to control an insertion distance of each conductive needle element. As evidenced by Kodama and Gelfand, it is known in the art to guard against the over-insertion of a needle to prevent against cell damage and to confirm that the needle is in a correct position relative to the cells and biological medium. Stops and markings may facilitate automated control over the insertion step when Garcia Dominguez’s conductive elements are coupled to the ends of the insulating structure.
With respect to claim 16, Garcia Dominguez, Ziv, Kodama and Gelfand disclose the combination as described above. Although Garcia Dominguez does not expressly teach that the controller includes a computer with a display, it is noted that displays, monitors, alarms, alerts and other “indicators” are typical and standard components of a computer controller, and therefore it would have been obvious to ensure that the Garcia Dominguez system includes such an indicator to display electroporation variables and parameters (e.g., applied current).
Response to Arguments
Applicant's arguments filed 03 April 2026 have been fully considered but they are not persuasive.
Applicant argues that Garcia Dominguez does not teach a channel of constant diameter. However, Garcia Dominguez teaches that the Fig. 23C embodiment is characterized as having a constant diameter. Paragraph [0146] states that “[t]he straight microchannel (FIG. 23C) is 50 μm in width, with a constant cross-sectional area along its entire 3 mm length”. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123. It is agreed that Garcia Dominguez discusses other embodiments in which the diameter of the flow channel is not constant and includes constrictions, but this does not defeat the fact that Garcia Dominguez teaches that the flow channel may alternatively be characterized by a constant diameter. Garcia Dominguez teaches channels that have varying diameters and constant diameters.
PNG
media_image3.png
364
504
media_image3.png
Greyscale
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
Prosecution Insights