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 .
Information Disclosure Statements
The information disclosure statements filed December 9, 2024, April 23, 2025 and July 10, 2025 have been entered and the references cited therein have been considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 5, 12 and 19 are 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.
In claims 5, 12 and 19, the phrase “and/or” renders the claims vague and indefinite as the metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-5 and 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Byrd et al. (U.S. Patent Application Publication No. 2021/0161582).
In regard to claims 1-3, 8-10 and 15-17, Byrd et al. teach an electroporation system 10 (see para. 0023) comprised of a catheter 14 with an electrode assembly 12 and an electroporation generator 26 coupled to the catheter 14 (see Fig. 1). Electroporation generator 26 and/or a computer system 32 may be programmed to run an algorithm that identifies and/or selects which electrodes or electrode pairs of electrode assembly 12 to energize (see para. 0029). Electroporation generator 26 is configured to energize the electrode elements by producing an electric current that is delivered via electrode assembly 12 as a pulsed electric field (see paras. 0051 and 0055). Figure 7 shows a pulse signal 700 (pulse pattern) generated by electroporation generator 26 that is a biphasic pulse signal including a first phase 702 having a first voltage amplitude 704 with a first polarity and a first pulse duration 706 and a second phase 708 having a second voltage amplitude 710 a second polarity opposite to the first polarity and a second pulse duration 712 (see also para. 0057). Figure 8 shows a burst signal 800 including two consecutive pulse signals 700 (first and second pulse patterns) generated at a pulse period 802 (see also para. 0069). Pulse period 802 may be any suitable period, such as 0.5 ms to 50 ms (see para. 0069). With further respect to claim 15, see para. 0006 of Byrd et al. In regard to claims 4, 11 and 18, see Figure 9 and para. 0072 of Byrd et al. In regard to claims 5, 12 and 19, see Figure 7 and para. 0059 of Byrd et al. In regard to claim 7, see paras. 0075-0083 of Byrd et al. In regard to claims 13, 14 and 20, see Figure 7 and para. 0058 of Byrd et al.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (U.S. Patent Application Publication No. 2021/0161582) in view of Krimsky et al. (U.S. Patent Application Publication No. 2020/0398048).
In regard to claim 6, Byrd et al. teach that the electrodes of electrode assembly 12 may be energized sequentially such that only some of the electrodes are energized at a given time and teach the sequential energization of pairs of electrodes (see para. 0052). However, Byrd et al. are silent as to sequential delivery of energy between the first and second pulse patterns. However, Krimsky et al. teach a similar electroporation device with sequential delivery of energy to electrodes where the sequence involves delivering spaced apart packets in an overlapping pattern to the electrodes 212a, 212b,212c rather than a serial pattern (see Fig. 15 and para. 0154). The packets are delivered to each electrode with rest periods that cause cell damage to occur over a longer period of time and increasing transmural penetration (see para. 0154). Krimsky et al. thus demonstrate that overlapping delivery of energy to electrodes is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to apply the method of overlapping delivery of energy to the electrodes in the device of Byrd et al. in order to cause cell damage over a longer period of time and increase transmural penetration.
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
Prosecution Insights