DETAILED ACTION
Applicant's amendments and remarks, filed 10/23/25, are fully acknowledged by the Examiner. Currently, claims 25-44 are pending with claims 25-27, 33-36, 39, 41-42, 44 amended. Applicant's amendment to claims 26 and 39 has overcome the previously filed objection. The following is a complete response to the 10/23/25 communication.
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 (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.
Claim Objections
Claims 25 is objected to because of the following informalities: "extendable though" should be "extendable through". Appropriate correction is required.
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.
Claim(s) 25-29 and 33-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomeranz (US 5,882,346) in view of Pearson (US 2010/0152725), in further view of Stewart (US 2016/0166310).
Regarding claim 25, Pomeranz teaches ablation equipment for treating target regions of tissue in organs (Fig. 1), comprising: an ablation catheter (catheter 10) and a power source (col. 4, lines 1-5);said ablation catheter comprising: a catheter elongated shaft (catheter 10 with a shaft 16) comprising at least an elongated shaft distal portion (14); said catheter elongated shaft comprising a flexible body to navigate through body vessels (at least Fig. 3a with catheter 10 flexibly navigating through the body): said ablation catheter further comprising a shaft ablation assembly disposed at said elongated shaft distal portion (ablation assembly 14);said shaft ablation assembly comprising at least a first plurality of electrodes (18) fixedly disposed at said elongated shaft distal portion (18 disposed on 14); and all electrodes of said at least a plurality being electrically powered by said power source (18 powered by the source in col. 4, lines 1-5).
Pomeranz is silent regarding the electrodes powered by a power source through an electric signal to deliver non-thermal energy for treating and ablating the tissue: wherein said electric signal comprises a sinusoidal wave,
wherein said electric signal is supplied to the electrodes of said plurality during a time interval, and wherein said electric signal is a sinusoidal pulse train comprising two or more basic sine waves in said time interval, wherein each basic sine wave consists of one positive half wave and one negative half wave.
However, Pearson teaches an electrosurgical device using electroporation to treat tissue (par. [0034]), the electric signal comprises a sinusoidal wave (par. [0035] RF signals are sinusoidal with a positive and negative wave), wherein said electric signal is supplied to the electrodes of said plurality during a time interval (par. [0043]), and wherein said electric signal is a sinusoidal pulse train comprising two or more basic sine waves in said time interval (RF signals over the duration of par. [0043] would be two or more waves).
It would have been obvious to one of ordinary skill in the art to modify Pomeranz with the electrosurgical device using electroporation as in Pearson, as an alternative way to ablate tissue, while minimizing damage to surrounding structures (par. [0008]).Pomeranz is silent regarding a distal ablation assembly extendable though said shaft ablation assembly and out from said elongated shaft distal portion via a port of said ablation catheter.However, Stewart teaches a distal ablation assembly (electrode array 48 as in par. [0027] at the desired target area) extendable through said shaft ablation assembly and out from said elongated shaft distal portion via a port of said ablation catheter (48 extendable from within 40), said distal ablation assembly comprising at least a second plurality of electrodes fixedly disposed along said distal ablation assembly (electrodes 18 fixed to 48), said distal ablation assembly configured to conform to a predefined shape such that the second plurality of electrodes are arranged according to the predefined shape upon said distal ablation assembly extending out from said elongated shaft distal portion via said port (48 to assume a circular shape as in par. [0027] and Fig. 2). It would have been obvious to one of ordinary skill in the art to modify Pomeranz with the distal ablation assembly of Stewart, to allow for a portion that can form different shape configurations at the distal end of the device to treat different tissue types (par. [0027]).
Regarding claim 26, Pomeranz teaches wherein said power source is single power source (source in col. 4, lines 1-5).
Regarding claim 27, Pomeranz teaches wherein said power source comprises a control unit and a power unit for generating said electric signal comprising a sinusoidal wave (rf signal), and wherein said power unit is electrically connected to all electrodes of said at least a plurality of electrodes (source in col.4 lines 1-5 for the electrodes).
Regarding claim 28, Pomeranz is not explicit wherein said control unit is configured to drive the power unit to modify the number of pulses in the sinusoidal pulse train to change the electric energy level associated to the electrical signal.
However, Pearson teaches adjusting the number of pulses to adjust the treatment of the tissue (par. [0040]).
It would have been obvious to one of ordinary skill in the art to be able to adjust the treatment parameters, as in Pearson, to tailor the treatment according to the desired outcome.
Regarding claim 29, Pomeranz is not explicit, but Pearson teaches wherein said sinusoidal pulse train electric signal comprises from two to twenty-five basic sine waves in said time interval (par. [0043]).
It would have been obvious to one of ordinary skill in the art to be able to adjust the treatment
parameters such as number of waves, as in Pearson, to tailor the treatment according to the desired outcome.
Regarding claim 33, Pomeranz teaches wherein said ablation catheter comprising said catheter elongated shaft having a longitudinal main direction (catheter 10 formed by shaft as in Fig. 1 along a longitudinal axis), said catheter elongated shaft comprising said elongated shaft distal portion (distal portion 14), said elongated shaft distal portion comprising a shaft distal portion distal end (tip 20);
said ablation catheter comprising an inner lumen (28a) arranged within the catheter elongated shaft (28a within shaft of 10 as in Fig. 11);
said ablation catheter comprising:
said shaft ablation assembly (electrodes 18) fixedly disposed at said elongated shaft distal portion (17), the shaft ablation assembly being configured to deliver the energy for treating and ablating said tissue (electrodes 18 to treat tissue); and
at least a shape setting mandrel (core wire 12) moveable within the ablation catheter (12c in the catheter as in Fig. 11), the shape setting mandrel being insertable within the inner lumen (12 within 28) and removable from the inner lumen (col. 6, lines 13-22), wherein the shape setting mandrel is free to move in respect of the inner lumen avoiding any constraint with said shaft distal portion during the shape setting mandrel insertion (col. 6, lines 13-22),
wherein the shape setting mandrel comprises at least a pre-shaped configuration (col. 3, lines 48-52) and the shape setting mandrel is reversibly deformable between at least a straight loaded configuration and said pre-shaped configuration (col. 4, lines 51-60), and
wherein, when the shape setting mandrel is fully inserted in the shaft distal portion, the shape setting mandrel is configured to shape set said shaft distal portion with said pre-shaped configuration (col. 4, lines 51-60).Pomeranz is not explicit regarding the shaft configured to receive the distal ablation assembly, and the mandrel disposed on said distal ablation assembly.However, Stewart teaches the distal ablation assembly as in claim 25, with shape modifying elements (par. [0027]).It would have been obvious to one of ordinary skill in the art to modify Pomeranz with the distal ablation assembly of Stewart, to allow for a portion that can form different shape configurations at the distal end of the device to treat different tissue types (par. [0027]).
Regarding claim 34, Pomeranz teaches wherein said shaft distal portion is elastically deformable and/or wherein when the shape setting mandrel is fully inserted in the shaft distal portion (12 inserted into 14 of catheter 10), said shaft distal portion is configured to conform to said pre-shaped configuration (col. 4 lines 51-60).
Regarding claim 35, Pomeranz teaches wherein when the shape setting mandrel is fully inserted in the shaft distal portion it is defined as a mandrel fully inserted position (12 inserted into 28), and wherein while the shape setting mandrel slides within the inner lumen towards said mandrel fully inserted position (12 slides within lumen 28), and wherein the shape setting mandrel is configured to variably shape set the shaft distal portion passing from said loaded straight configuration to said pre-shaped configuration (col. 5, lines 27-45).
Regarding claim 36, Pomeranz is silent wherein each basic sine wave consists of one positive half-wave and one negative half-wave, and wherein each basic sine wave comprises a duration equal to a first-time interval.
However, Pearson teaches sine waves consists of one positive half-wave and one negative half-wave (sine waves comprise positive and negative half waves to equal a full wave), and wherein each basic sine wave comprises a duration equal to a first-time interval (par. [0043]).
Regarding claim 37, Pomeranz is silent, but Pearson teaches wherein said control unit is configured to drive the power unit to modify the duration of the first-time interval of the basic sine wave to change the electric energy level associated to the electric signal (par. [0041] adjusting values).
Regarding claim 38, Pomeranz is silent, but Pearson teaches wherein said first-time interval is selected in the range of 1sec to 80.000 msec (par. [0042]).
Regarding claim 39, Pomeranz is silent, but Pearson teaches wherein said first time interval is selected in the range of 75 usec-20.000 msec (par. [0042]).
Regarding claim 40, Pomeranz is silent, but Pearson teaches wherein said first time interval is selected in the range of 20 usec-100 usec (par. [0042]).
Regarding claim 41, Pomeranz is silent, but Pearson teaches herein the sinusoidal pulse train electric signal is supplied to the electrodes during a time interval selected in the range of 100 psec-100 sec (par. [0042]).
Regarding claim 42, Pomeranz teaches wherein the electrodes of said at least a plurality are electrically powered by said power source (electrodes 18 powered by source) to deliver a voltage to treat the target regions of tissue (electrodes 18 to treat tissue), but is not explicit regarding in the range of 100 V/cm-7000 V/cm.
However, Pearson teaches voltage ranges within this range (par. [0042]).
Regarding claim 43, Pomeranz is not explicit, but Pearson teaches wherein the voltage to treat the target regions of tissue is selected in the range of 200 V/cm-2000 V/cm or selected in the range of 300 V/cm-1000 V/cm (par. [0042]).
Regarding claim 44, Pomeranz wherein at least one electrode of said plurality of electrodes
comprises two conductive portions electrically isolated from each other and/or wherein at least one electrode of said plurality of electrodes comprises four conductive portions electrically isolated from each other (at least four electrodes 18 isolated from each other as in Fig. 1).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomeranz in view of Pearson, in view of Stewart, in further view of Long (US 2012/0220998).
Regarding claim 30, Pomeranz teaches wherein said electric signal comprising a sinusoidal wave is a voltage signal, and wherein a peak-to-peak mean amplitude of each basic sine wave is in the range of 1,000 to 2,000 V.
However, Long teaches pulse amplitudes of 1000V (par. [0075]).
It would have been obvious to one of ordinary skill in the art to modify Pomeranz with the peak-to-peak mean amplitude of Long, as an amplitude strong enough to ablate tissue.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomeranz in view of Pearson, in view of Stewart, in further view of Curran (US 2019/0117113).
Regarding claim 31, Pomeranz is not explicit, but Pearson teaches wherein said power unit comprises a power module comprising:
a drive circuit block controlled by the control unit for generating said electric signal starting from a supply voltage signal provided by the control unit (par. [0038] generating source);
a selecting block selectively controlled by said drive circuit block to change continuously the electric energy level associated to said signal (adjusting according to the desired signal as in par. [0042]).
It would have been obvious to one of ordinary skill in the art to be able to adjust the treatment parameters, as in Pearson, to tailor the treatment according to the desired outcome.
Pomeranz is silent regarding a filtering and electrical isolation block.
However, Curran teaches a filtering and isolation block (par. [0058] filter to smooth the signal, isolation to isolate medical device from the source).
It would have been obvious to one of ordinary skill in the art to modify the combination with the filter and isolation blocks of Curran, to provide a safe and effective signal for treatment.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomeranz in view of Pearson, in view of Stewart, in further view of Khan (US 2019/0175272).
Regarding claim 32, Pomeranz teaches a variable High Voltage Power Supply block being configured to provide said supply voltage signal to the power module for generating said electric signal (col. 3 line 63 to col. 4 line 9), but is silent regarding the specifics of the control unit.
However, Khan teaches wherein said control unit (400) comprises:
a Microprocessor (par. [0275]) configured to control a Power Supply block (par. [0166]) and a Programmable Logic Controller block (par. [0274]);
said Programmable Logic Controller block (409) being configured to generate drive signals to control the drive circuit block (403) of the power module (402); and said control unit (400) further comprising:
a Video interface and Push Button block controlled by the Microprocessor to set parameters of the equipment and display the selected parameters (display 20 and unput 22 as in par. [0149]);
a Watch Dog block (175) for controlling proper functioning of the Microprocessor (watchdog as hardware failsafe as in par. [0115]); and
an Audio interface block for providing audio information representative of correctness of the ablation process and/or errors occurred (par. [435]).
It would have been obvious to one of ordinary skill in the art to modify Pomeranz with the control unit structure of Khan, to allow for circuitry to interact with and control the energy to be delivered. While Khan uses laser to treat tissue, one of ordinary skill in the art would appreciate that controlling a treatment would require similar circuitry for a user to interface with the device.
Response to Arguments
Applicant’s arguments, see the remarks, filed 10/23/25, with respect to the rejection(s) of claim(s) 25-44 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stewart.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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.
/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794