DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-8 & 19 & Species B (Fig. 11) in the reply filed on 12/14/2025 is acknowledged.
Claims 9-18 & 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/14/2025.
The Examiner further withdraws claim 8 directed to an “electrode tip [that] is configured to be rotatable” which corresponds to non-elected Species D: Fig. 32-33.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. PCT/US2022/014431 & 63/191164 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 5/20/2021.
Drawings
The drawings are objected to because:
Figs. 1-3 & 6 contain text labels.
Figs. 8, 23-26, 28-31 & 34-41 contain multiple figures per figure number.
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.
Specification
The disclosure is objected to because of the following informalities: amend Par. [0001] with correct priority information.
Appropriate correction is required.
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 1-7 & 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.
Claim 1 recites the limitation “A tissue ablation system…whereby tissue located between the at least one tip electrode and the at least one return electrode acts as a capacitive dielectric medium in which an electric field is present and is not dependent on current flow between the at least one tip electrode and the at least one return electrode, and the electric field induces electroporation of tissue cells in a vicinity of the distal electrode tip” which is a method step in a product claim. It is unclear if the claim is intended to be a product or a method claim as the term “whereby” fails to positively denote functional language. For purposes of examination, the limitation will be interpreted as a product claim as: -A tissue ablation system…whereby tissue located between the at least one tip electrode and the at least one return electrode is configured to act as a capacitive dielectric medium in which an electric field is present and is not dependent on current flow between the at least one tip electrode and the at least one return electrode, and the electric field is configured to induce electroporation of tissue cells in a vicinity of the distal electrode tip” which is a method step in a product claim-.
Claim 1 recites the limitation “tissue” in ll. 12 and “tissue cells” in ll. 14. It is unclear if the “tissue” in each of the limitations is the same or different. For purposes of examination, they will be interpreted as being the same and as: -cells of the tissue- in ll. 14.
Claims 2-7 & 19 depend from claim 1 are thus also rejected.
Claim Interpretation
Claim 1 recites the limitation “non-conductive surface layer”. The Examiner notes that under BRI, this can be interpreted as either electrically or thermally “non-conductive”.
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.
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) 1-4 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (2019/0223948) in view of Villemajane et al. (2011/0141649).
Concerning claim 1, as illustrated in at least Fig. 3, Stewart et al. disclose a tissue ablation system (medical system 10; [0091]) comprising:
a catheter including a distal electrode tip having at least one tip electrode, wherein the at least one tip electrode comprises a non-conductive surface layer (energy delivery device 16 may be a catheter and has energy delivery electrode 12; [0080]);
at least one return electrode positionable independently of the at least one tip electrode, wherein the at least one return electrode comprises a non-conductive surface layer (energy return electrode(s) 14; [0085]); and
a voltage generator circuit electrically connected to the at least one tip electrode and to the at least one return electrode, wherein the voltage generator circuit is operable to apply a voltage differential across the at least one tip electrode and the at least one return electrode such that the at least one tip electrode is given a polarity opposite a polarity of the at least one return electrode; whereby an electric field is present, and the electric field induces electroporation of tissue cells in a vicinity of the distal electrode tip (pulsed field ablation energy is delivered to induce electroporation of tissue between the energy delivery electrode 12 and the energy return electrode 14, the electrical current is transmitted from the energy generator 22 to the at least one energy delivery electrode 12, and is then delivered from the at least one energy delivery electrode 12 to the tissue (for example, an area of target tissue), and the electrical current then flows from the at least one energy delivery electrode 12 to the at least one energy return electrode 14, due to the larger surface area of the at least one energy return electrode 14, where energy delivery between the energy delivery electrode(s) 12 and the energy return electrode(s) 14 is considered to be unipolar energy delivery because the electrode area of the energy return electrode(s) 14 is greater than the electrode area of the energy delivery electrode(s) 12; [0078], [0084-0085]).
Stewart et al. fail to specifically disclose the at least one tip electrode and the at least on return electrode comprising a non-conductive surface layer and whereby tissue located between the at least one tip electrode and the at least one return electrode acts as a capacitive dielectric medium in which an electric field is present and is not dependent on current flow between the at least one tip electrode and the at least one return electrode. However, Villemajane et al. disclose a tissue treatment system comprising two electrodes (4) comprising a non-conductive surface layer (7) and whereby tissue located between the two electrodes (4) acts as a capacitive dielectric medium in which an electric field is present and is not dependent on current flow between the two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stewart et al. such that the at least one tip electrode and the at least on return electrode comprising a non-conductive surface layer in order to provide the benefit of freeing electrodes from biocompatibility constraints such that the electrode main body can be obtained in any desired conductive material optimal for tissue and the desired procedure or treatment without being limited to a choice among biocompatible authorized materials as taught by Villemajane et al. ([0011], [0053-0056], [0076-0076]; Fig. 1-2)
Concerning claim 2¸ Stewart et al. disclose the at least one return electrode (14) has a surface area greater than a surface area of the at least one tip electrode ([0085]; Fig. 3).
Concerning claim 3¸ Stewart et al. disclose the at least one return electrode (14) is separate from the catheter (10) ([0085], [0091]; Fig. 3).
Concerning claim 4¸ Stewart et al. disclose the at least one return electrode (14) is embodied in a patch configured for external placement on a skin surface ([0085], [0091]; Fig. 3).
Concerning claim 7¸ Stewart et al. disclose the catheter (10) is a steerable catheter ([0080]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (2019/0223948) in view of Villemajane et al. (2011/0141649), as applied to claim 1, in further view of Viswanathan et al. (2018/0311497).
Concerning claims 5-6¸ Stewart et al. in view of Villemajane et al. fail to specifically disclose the voltage generator circuit is an AC voltage generator circuit or a DC voltage generator circuit. However, Viswanathan et al. disclose a tissue ablation system comprising a voltage generator circuit (810) configured to apply a voltage differential across electrodes, wherein the voltage generator circuit is an AC voltage generator circuit or a DC voltage generator circuit ([0040]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stewart et al. in view of Villemajane et al. such that the voltage generator circuit is an AC voltage generator circuit or a DC voltage generator circuit in order to provide the benefit of generating the desired pulse waveforms for treatment of tissue as taught by Viswanathan et al. ([0040]) and since it would have been obvious to try either an AC voltage generator circuit or a DC voltage generator circuit as AC or DC circuits are from a finite number of identified, predictable solutions, with a reasonable expectation of success of generating the pulsed waveforms in view of the teachings of Viswanathan et al.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (2019/0223948) in view of Villemajane et al. (2011/0141649), as applied to claim 1, in further view of Palti (2006/0167499).
Concerning claim 19¸ Stewart et al. in view of Villemajane et al. fail to disclose the at least one return electrode includes a high-dielectric ceramic with a relative permittivity from 200 to 3500. However, Palti discloses a treatment system comprising a return electrode coated with a non-conductive high-dielectric dielectric insulation layer having a relative permittivity in the range of 200-3500. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stewart et al. in view of Villemajane et al. such that the at least one return electrode includes a high-dielectric ceramic with a relative permittivity from 200 to 3500 in order to provide the benefit of increasing capacitance of the electrode, thus reducing the voltage drop between electrodes such that a larger portion of the applied voltage appears across the tissue as taught by Palti. ([0027], [0093-0094], [0096-0099]; Fig. 5 & 7)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Zarins et al. (2016/0184012) and Eyster et al. (2021/0393327) disclose monopolar electroporation. Weissberg et al. (2013/0150935) disclose coated electrodes.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794