CTNF 18/858,738 CTNF 71152 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Preliminary Amendment The preliminary amendment filed October 21, 2024 has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 6, 20 and 27 are amended; claims 1-5, 9, 11-12, 15, 17-20, 23, 24 remain as originally presented; claims 7, 8, 13, 14, 21, 22, 25 and 26 are canceled; claims 27-30 are newly presented. Information Disclosure Statements The information disclosure statements filed November 27, 2024 and January 18, 2025 have been entered and the references cited therein have been considered by the examiner. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 9 recites “wherein a number of pulses is selected” when the provision of electrical pulses is not recited in independent claim 1, from which claim 9 depends. Accordingly, this recitation lacks proper antecedent basis. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-02-aia AIA Claim s 1-6, 9, 11, 12, 15-20, 23, 24 and 27-30 is/are rejected under 35 U.S.C. 103 as being obvious over Rubinsky et al. (U.S. Patent Application Publication No. 2021/0220532) . The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. In regard to claims 1, 5, 9, 12, 16, 23, 24 and 27-30 , Rubinsky et al. teach a multimodality electrolysis system 100 capable of performing electrolysis and at least one other treatment, such as cellular permeabilization treatment including a controller 105 coupled to an electrolysis device 110 and a cellular permeabilization device 115 (see Fig. 1 and para. 0026). The devices 110, 115 are placed proximate to a treatment site on tissue 10 (see Fig. 1 and para. 0026). The controller 105 may control the timing, strength and duration of treatments provided by the devices 110, 115 and the controller 105 may be programmed to provide an electronic signal to the devices 110, 115 such as the timing and magnitude of a current generated by the electrolysis device 110 and/or the cellular permeabilization device 115 (see para. 0027). The controller 105 may be programmed to provide an electronic signal indicative of a dose of the electrolysis produces and/or a permeability level of cells, which may be embedded in a program or include one or more processing device coupled to a memory encoded with executable instructions for electrolysis treatment and/or cellular permeabilization treatment (see para. 0029). The electrolysis device 110 includes one or more electrodes for conducting a current through a solution and the cellular permeabilization device 115 may perform reversible and/or irreversible permeabilization using one or more electrodes for generating a potential difference across tissue for permeabilizing cells (see paras. 0031-0032). The electrolysis device 110 and the cellular permeabilization device 115 may be a single device (see para. 0033). For a method of use, see paras. 0036-0037 and Figs. 2A and 2B). Rubinsky et al. teach that the time, duration and order of treatments may be chosen based on the desired effect on the target site, the size of the target site and/or local physiological conditions of the target site (see para. 0038). Rubinsky et al. also teach one or more sensors for measurement of pH 125, electric field strength 130 and/or other properties of the tissue (see para. 0030). The pH sensor 125 functions to detect when the pH has reached a desired level, which indicates proper ablation of tissue (see para. 0030). Rubinsky et al. do not specifically state that the device is used such that an extracellular matrix is left intact in the targeted tissue providing a scaffold for tissue regeneration. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Rubinsky et al. does not include any structural limitations that would preclude its use for leaving an extracellular matrix intact. In fact, Rubinsky et al. teach monitoring of the pH level with the pH sensor 125 (monitoring the products of electrolysis) in an effort to optimize the procedure (see above). Thus, the device taught by Rubinsky et al. is capable of being used to leave an extracellular matrix intact and one of ordinary skill in the art at the effective filing date of the invention would have been motivated to utilize the device in such a manner. Finally, it should be noted that it has been held that 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 satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In regard to claims 2-4 and 17-19 , see Figs. 6A and 6B and para. 0045 of Rubinsky et al. With further respect to claim 19 , see para. 0041 of Rubinsky et al. In regard to claims 6, 11 and 20 , see para. 0044 of Rubinsky et al. In regard to claim 15 , see para. 0030 of Rubinsky et al. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM. 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, Joanne Rodden can be reached at (303) 297-4276. 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. /BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794 Application/Control Number: 18/858,738 Page 2 Art Unit: 3794 Application/Control Number: 18/858,738 Page 3 Art Unit: 3794 Application/Control Number: 18/858,738 Page 4 Art Unit: 3794 Application/Control Number: 18/858,738 Page 5 Art Unit: 3794 Application/Control Number: 18/858,738 Page 6 Art Unit: 3794 Application/Control Number: 18/858,738 Page 7 Art Unit: 3794 Application/Control Number: 18/858,738 Page 8 Art Unit: 3794
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