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 Statement
The information disclosure statement filed August 2, 2024 has been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
Applicant’s preliminary amendment, filed April 12, 2024, has been entered. Accordingly, claims 1-49 are canceled; claims 50-74 are newly added.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the second spacer 1054’ as described in the specification at paragraph 000119 (specifically, Figure 10D). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 55, 57 and 67-74 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.
Claim 55 recites “the second electrode is configured to avoid abrupt changes in angle between walls of the tip region and tissue.” This recitation is vague and indefinite as there is no structural element recited that performs the recited function and therefore it cannot be determined what applicant intends to claim.
Claims 57 and 67 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, 52-57, 59, 60, 65 and 66 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Willis (U.S. Patent Application Publication No. 2015/0126922).
In regard to claims 50, 52-56 and 66, Willis teaches an energy delivery probe 13 for pulsed electric field ablation (see para. 0062) comprised of a handle 17 and a tip region having electrodes 4, 40 where electrode 40 is a cannula and electrode 4 is a trocar (see Figs. 1 and 5A and para. 0066). Figure 5A shows that trocar electrode 4 has a distal cutting region and a proximal non-cutting region that has a curved, conical surface (see also para. 0068). Figure 5A also shows that trocar electrode 4 has one or more blade edges extending proximally to cut tissue and the proximal non-cutting region 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 (see also para. 0068). The use of a trocar shape on trocar electrode 4 would inherently include three or more cutting blade edges (as is conventional in a trocar shape) and would inherently increase hoop stress as it pierces and penetrates tissue. Figure 5A also shows that the circumference of the distal cutting region is about 5% to about 50% of a full circumference of the electrode 4 at the proximal non-cutting region. In addition, Figure 5A shows that trocar electrode 4 is configured to avoid abrupt changes in an angle between the walls of the tip region and tissue as it is tapered. Figure 5A also shows that a change in angle between each of the one or more blade edges relative to a long axis of the tip region as it transitions to the smooth face is less than 20 degrees. Willis also teaches an insulation sleeve 45 that acts as a spacer between trocar electrode 4 and electrode 40 (see Fig. 5A). In regard to claim 57, Willis teaches that the trocar 4 or cannula 40 can have at least one lumen or channel that extends along the longitudinal axis of the probe 13 that can be used to deliver or withdraw fluids (see para. 0077). In regard to claim 59, see para. 0089 of Willis. In regard to claim 60, see para. 0070 of Willis. In regard to claim 65, see Fig. 5A of Willis.
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 51, 58, 61-64 and 67-74 is/are rejected under 35 U.S.C. 103 as being obvious over Willis (U.S. Patent Application Publication No. 2015/0126922) 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, Willis is 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 Willis 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 58 and 64, 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 Willis with a space that has a wider circumference than the trocar electrode 4 or the electrode 40 or that tapers as changes in the size of a prior art device are a design consideration within the skill of the art. In regard to claim 61, 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 and 69, see Fig. 5 of Davitz et al. In regard to claims 72-74, see para. 0108 of Willis.
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.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794