DETAILED ACTION
The following is a 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.
Response to Amendment
Acknowledgment is made to the amendment received 7/16/2026.
Applicant’s amendments are sufficient to overcome some of the drawing objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the specification objections set forth in the previous office action, but a new matter rejection is set forth below due to the amendment.
Drawings
The drawings are objected to because: Figs. 34A-B, 36A-B, 37A-B & 40A-B 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 amendment filed 7/16/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the PCT is regarded as new matter. “An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application.” (see MPEP §1893.03(b)). “An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a))”. (See MPEP §608.01(p) I B)
Applicant is required to cancel the new matter in the reply to this Office Action.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 7 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (2019/0223948, previously cited) in view of Villemajane et al. (2011/0141649, previously cited) and Palti (2006/0167499, previously cited).
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)
Stewart et al. in view of Villemajane et al. fail to disclose a frequency associated with the voltage differential is from 100 kHz to 250 kHz. However, Palti discloses a treatment system comprising two electrodes both comprising a non-conductive surface layer (230) and a voltage generator (210) operably to apply a voltage differential between the electrodes (230) at a frequency in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Stewart et al. in view of Villemajane et al. such that a frequency associated with the voltage differential is from 100 kHz to 250 kHz as Applicant appears to have placed no criticality on the claimed range (see pp. [0108] indicating the angle “may” have an upper range of 250 or 300 kHz and [0137] indicating the frequency varied from 25-500 kHz) in order to provide the benefit of an electric field that has bio-effective field properties while having no meaningful stimulatory and thermal effects as taught by Palti ([0079], [0089-0090]; Fig. 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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]).
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)
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (2019/0223948, previously cited) in view of Villemajane et al. (2011/0141649, previously cited) and Palti (2006/0167499, previously cited), as applied to claim 1, in further view of Viswanathan et al. (2018/0311497, previously cited).
Concerning claims 5-6¸ Stewart et al. in view of Villemajane et al. and Palti 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. and Palti 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.
Response to Arguments
Applicant’s arguments 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.
IN response to Applicant’s arguments it would not be obvious to modify the frequency of Stewart as the pulse-field energy disclosed in Stewart is sufficient for treatment, the Examiner respectfully disagrees as Palti teaches various frequency-tissue interactions, where the frequency in the range of 100-300 kHz is ideal to impart bio-effective field properties while having no meaningful stimulatory and thermal effects where the frequencies are sufficiently low so that the system behavior is determined by the system's Ohmic (conductive) properties but sufficiently high enough not to have any stimulation effect on excitable tissue ([0079]).
IN response to Applicant’s arguments Palti fails to teach the recited permittivity, the Examiner respectfully disagrees as Par. [0099] specifically gives example materials with the required permittivity, or dielectric constant.
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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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