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 .
Response and Amendment Filed
Applicant’s response and amendment, filed April 13, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed January 13, 2026) is as follows:
The objection to the drawings under 37 CFR 1.83(a) has been overcome by the filing of a corrected sheet of drawings with the 4/13/26 response.
The 35 USC 112(b) rejection of claims 55, 57 and 67-74 has been overcome with respect to claim 55, but is maintained with respect to claims 57 and 67-74 and is applied to newly filed claim 79 as below.
The 35 USC 102 rejection of claims 50, 52-57, 59, 60, 65 and 66 as being anticipated by Willis (U.S. Patent Application Publication No. 2015/0126922) is hereby withdrawn.
The 35 USC 103 rejection of claims 51, 58, 61-64 and 67-74 as being unpatentable over Willis (U.S. Patent Application Publication No. 2015/0126922) in view of Danitz et al. (U.S. Patent Application Publication No. 2020/0261720) is hereby withdrawn.
The following new and reiterated grounds of rejection are set forth:
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 57, 67-74 and 79 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.
Claims 57, 67 and 79 recite “and/or” which renders the claim vague and indefinite as the metes and bounds of the claims cannot be determined. As claims 68-74 depend from claim 67, they are likewise rejected.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 50-54, 56-60, 65, 66, 75-80 and 84 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Appling et al. (PCT Publication No. WO 2009/137800).
In regard to claims 50, 52, 56, 75 and 77, Appling et al. teach a device for tissue treatment (pulsed electric field ablation) comprised of a handle 50 and an elongated probe 10 that has a tip region having a at least a first voltage delivery region 14 and a second voltage delivery region 12 with at least one electrically insulating region 13 (spaced) that separates the at least two voltage delivery regions 12, 14 (see Fig. 1 and paras. 0022-0023). Figure 1 shows that the second and first voltage delivery regions 12, 14 are spaced apart in a non-overlapping manner that second voltage delivery region 12 has a tip 11 that can be part of voltage delivery region 12 and has a beveled profile (3-sided trocar tip) to enable or facilitate percutaneous application of probe 10 (see also Figs. 2 and 3 and paras. 0025-0026). Figured 2 and 3 also show that the tip 11 has a distal cutting region and a proximal non-cutting region where the distal cutting region has one or more blade edges extending proximally and configured to cut tissue and a proximal non-cutting region that has a smooth face extending proximally from a proximal end of the one or more blade edges where the smooth face is configured to stretch and expand tissue and increase hoop stress. In regard to claim 51, see para. 0083 of Appling et al. In regard to claims 53 and 54, Figures 2 and 3 of Appling et al. show that the distal cutting region is about 5% to about 50% of a full circumference of the second voltage delivery region 12 at the proximal, non-cutting region and that the proximal non-cutting region comprises a curved conical surface. In regard to claims 57 and 79, see para. 0026 of Appling et al. In regard to claim 58, see para. 0023 of Appling et al. In regard to claims 59, 60, 65, 80 and 84, see paras. 0038-0047 of Appling et al. discussing different lengths for the voltage delivery regions 12, 14 and the electrically insulating region 13. In regard to claim 66, Figures 2 and 3 of Appling et al. show that a change in angle between the blade edges of tip region 11 relative to a longitudinal axis of the tip region 11 as they transition to the smooth face is less than 20 degrees. In regard to claim 76, see para. 0039 of Appling et al. In regard to claim 78, see Figure 1 of Appling 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.
Claims 61-64, 67-74 and 81-83 is/are rejected under 35 U.S.C. 103 as being obvious over Appling et al. (PCT Publication No. WO 2009/137800) in view of Danitz et al. (U.S. Patent Application Publication No. 2020/0261720).
The applied reference has a common inventor and assignee 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 67, 68 and 71, see the above rejection for claim 50. With further respect to claim 67 and in regard to claim 51, Appling et al. are silent as to the application of sub-microsecond pulses. However, Danitz et al. teach a similar probe device utilizing sub-microsecond pulsing at a duration of less than 1000 nanoseconds for the purpose of manipulating intracellular structures (see paras. 0004, 0011 and 0134). Danitz et al. thus demonstrate that the use of sub-microsecond pulsing at a duration of less than 1000 nanoseconds 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 equip the device of Appling et al. with the ability to deliver sub-microsecond pulsing at a duration of less than 1000 nanoseconds in order to better manipulate intracellular structures. In regard to claims 64 and 83, see Figs. 4-5 of Davitz et al. It would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Appling et al. with a spacer 13 that has a wider circumference than the voltage regions 12, 14 or that tapers as changes in the size of a prior art device are a design consideration within the skill of the art. See also para. 0028 of Appling et al. disclosing an additional spacing member 40. In regard to claims 61 and 81, see Figs. 14-18 of Davitz et al. In regard to claims 62 and 70, see Fig. 13 of Danitz et al. In regard to claims 63, 69 and 82, see Fig. 5 of Davitz et al. In regard to claims 72-74, see para. 0048 of Appling et al.
Allowable Subject Matter
Claim 55 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: The prior art does not teach or fairly suggest a spacer with an adjustable circumference where the spacer is configured to be expanded when in place for delivery of a pulsed electric field (see, e.g., Fig. 9A and para. 00087 of the instant application). Neither Appling et al. nor Danitz et al. disclose adjustable spacers.
Response to Arguments
Applicant’s arguments with respect to claim(s) 50-84 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Appling et al. is newly applied to teach first and second electrodes that are spaced apart from each other in a non-overlapping manner (as recited in amended independent claims 50 and 67 and in newly filed independent claim 75).
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 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, Linda Dvorak can be reached at 571-272-4764. 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