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 to Amendment
Examiner acknowledges that claims 1-5 and 7-23 are pending in the present application, with minor amendments made to the independent claims 1 and 7.
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.
Claim(s) 1-5, 7-8, 10-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US Patent No 20210282847) in view of Govari (US Patent No 20200129125) further in view of Smith (US Patent No 20130090651).
Regarding claim 1, Viswanathan teaches a medical probe (ablation device 700, [0106]), comprising: a shaft (catheter shaft 710, [0106]) defining a longitudinal axis (wherein the direction of the catheter shaft 710 defines the longitudinal axis, see in fig 7), the shaft configured for insertion into a cavity of an organ of a patient (wherein the system is used for ablating tissue within a lumen of a patient, [0004]); a basket assembly (wherein the set of splines 714 creates the basket assembly, [0106]) which is connected at a distal end of the shaft and extending along the longitudinal axis (see fig 7 for set of splines 714 connected to the distal end of the catheter shaft 710, [0106]), the basket assembly comprising: multiple electrically-conductive spines (see wherein the splines 714 contain conductive spline wires 718, [0106]) that are electrically-connected to one another so as to form a distributed electrode (wherein the splines are connected as seen in fig 7, and the ablation system as described may also include a distributed set of electrodes, [0332]);
Viswanathan does not teach a plurality of spine mounted electrodes, which are disposed along the spines and are configured to (I) sense electrical activity in the cavity, and (ii) prevent the distributed electrode from indenting tissue in the cavity.
However, the analogous electrode basket sensing and ablation system of Govari does teach a plurality of spine mounted electrodes (diagnostic electrodes 50, see fig 2A), which are disposed along the spines (see fig 2A for electrodes 50 disposed along the spines) and are configured to (I) sense electrical activity in the cavity (diagnostic electrode configured to sense electrical signals when in contact with the tissue, [0014]), and (ii) prevent the distributed electrode from indenting tissue in the cavity (diagnostic electrode 50 comes in contact with the surrounding tissue and blood wherein the splines 45 only come in contact with the surrounding blood, [0052], see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not, therefore there is no indenting of the tissue).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode basket ablation system of Viswanathan with the electrode basket sensing electrode of Govari in order to provide electrical sensing to an ablation system to allow the sensing to result in ideal ablation and energy delivery to the spines, as disclosed by Govari, [0014].
The previous combination does not teach at least one of the spine mounted electrodes comprising a through hole through which a spine of the multiple electrically-conductive spines is inserted into.
However, the analogous electrode spline medical device taught by Smith does disclose at least one of the spine mounted electrodes comprising a through hole through which a spine of the multiple electrically-conductive spines is inserted into (see Smith fig 2, as well as [0038] in which it is disclosed that the common electrode 30, or mounted electrode is joined and attached through the strut electrode 28, or conductive spines. In which it can be seen in fig 2 that the common electrode 30 is mounted on the strut electrode 28 via a hole through the middle of the electrode 30).
Therefore, it would have been obvious to one skilled in the art prior to the effective filing date to combine the basket catheter with conductive spines collectively taught by Viswanathan and Govari with the specific electrode mounting configuration disclosed by Smith in order to allow the mounted electrode to maintain distance between the spines and the contact point, as well as differentiating the electrical connection between the conductive spines and the mounted electrode, as taught by Smith, [0038].
Regarding claim 2, the combination teaches the medical probe according to claim 1, wherein the spines are electrically-connected to one another at a distal end of the basket assembly (Viswanathan, the splines 714 are tethered together via the distal cap 712 at the distal end of the basket, [0106]).
Regarding claim 3, the combination teaches the medical probe according to claim 1, wherein the spines are electrically-connected to one another at a proximal end of the basket assembly (Viswanathan, wherein the splines 714 are coupled together at the distal end of the shaft 710, which is also the proximal end of the basket assembly, [0106]).
Regarding claim 4, the combination teaches the medical probe according to claim 1, wherein the distributed electrode is configured to apply an ablation signal (Viswanathan, where the splines 714 are electrically conductive and used to supply ablation energy, [0106]).
Regarding claim 5, the combination teaches the medical probe according to claim 1, wherein the at least one spine mounted electrode comprising the through hole (from Smith, mounted electrode 30, fig 2) protrude radially outward from the spines and away from the longitudinal axis so as to prevent the distributed electrode from indenting the tissue (Govari , diagnostic electrode 50 comes in contact with the surrounding tissue and blood wherein the splines 45 only come in contact with the surrounding blood, [0052], see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not, therefore there is no indenting of the tissue).
Regarding claim 7, the combination teaches an end effector (Viswanathan, ablation device 700, [0106]) comprising: a tubular shaft extending along a longitudinal axis from a proximal portion to a distal portion (Viswanathan, catheter shaft 710, [0106]) a plurality of spines extending from the distal portion of the tubular shaft to define a basket (Viswanathan, wherein the set of splines 714 creates the basket assembly, [0106]), the plurality of spines being electrically connected to each other (Viswanathan, wherein the splines are connected as seen in fig 7, and the ablation system as described may also include a distributed set of electrodes, [0332]), each of the spines having exposed portions that are electrically conductive (Viswanathan, see wherein the splines 714 contain conductive spline wires 718, [0106], see also fig 7 for exposed conductive wires); and a plurality of spine mounted electrodes disposed on each of the spines (Govari , see fig 2A for electrodes 50 disposed along the spines) and electrically insulated from each of the spines (Viswanathan, see wherein the individual electrode leads for each electrode 716 may be comprised of insulation material to isolate the electrode from the spline, [0106]), each spine mounted electrode comprising a through hole through which a spine of the plurality of spines is inserted into (see Smith fig 2, as well as [0038] in which it is disclosed that the common electrode 30, or mounted electrode is joined and attached through the strut electrode 28, or conductive spines. In which it can be seen in fig 2 that the common electrode 30 is mounted on the strut electrode 28 via a hole through the middle of the electrode 30), the through hole being offset so that the electrode is offset and thicker in a direction away from the longitudinal axis (Govari , see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not as they protrude externally past the spines).
Govari does not explicitly say the electrodes are a scarab shape, however as this language was analyzed as indefinite, based on the broadest reasonable interpretation, Govari does disclose the electrodes having a shape which extend laterally past the spine and are therefore thicker than the spine. Therefore, Govari does disclose the claimed limitation based of the broadest reasonable interpretation.
Regarding claim 8, the combination teaches the end effector of claim 7, further comprising basket actuator extending from the tubular shaft to a distal end of the basket and connected to the spines so that movement of the actuator along the longitudinal axis causes a change in shape of the basket (Viswanathan, see [0148] in which it is disclosed how there may be two different catheters 3510 and 3520 in which the second catheter extends from the tubular shaft and is in actuating member to translate and change the shape of the catheter splines 3530).
Regarding claim 10, the combination teaches the end effector of claim 7, further comprising a reference electrode (Govari , reference electrode 55, [0046]) disposed on a member extending from the tubular shaft disposed within the spines and about the longitudinal axis (Govari , see fig 2A in which the reference electrode is disposed within the interior edge of the spine 45 which extends from the tubular shaft 22).
Regarding claim 11, the combination teaches a method of ablating tissues (Viswanathan, ablation device 700, [0106]) comprising: inserting, into a cavity of an organ of a patient, a medical probe comprising a shaft (Viswanathan, wherein the system is used for ablating tissue within a lumen of a patient, [0004]) and a basket assembly connected at a distal end of the shaft (Viswanathan, wherein the set of splines 714 creates the basket assembly, [0106]), the basket assembly comprising (I) multiple electrically-conductive spines that are electrically-connected to one another with exposed portions of the spines so as to form a distributed electrode (Viswanathan, wherein the splines are connected as seen in fig 7, and the ablation system as described may also include a distributed set of electrodes, [0332]), and (ii) a plurality of spine mounted electrodes disposed along the spines (Govari , see fig 2A for electrodes 50 disposed along the spines) and electrically insulated from the spines (Viswanathan, see wherein the individual electrode leads for each electrode 716 may be comprised of insulation material to isolate the electrode from the spline, [0106]); at least one of the spine mounted electrodes comprising a through hole through which a spine of the multiple electrically-conductive spines is inserted into (see Smith fig 2, as well as [0038] in which it is disclosed that the common electrode 30, or mounted electrode is joined and attached through the strut electrode 28, or conductive spines. In which it can be seen in fig 2 that the common electrode 30 is mounted on the strut electrode 28 via a hole through the middle of the electrode 30) and sensing electrical activity in the cavity with the spine mounted electrodes (Govari , diagnostic electrode configured to sense electrical signals when in contact with the tissue, [0014]) while preventing the distributed electrode from indenting tissue in the cavity (Govari , diagnostic electrode 50 comes in contact with the surrounding tissue and blood wherein the splines 45 only come in contact with the surrounding blood, [0052], see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not, therefore there is no indenting of the tissue).
Regarding claim 12, the combination teaches the method according to claim 11, wherein the spines are electrically-connected to one another at a distal end of the basket assembly (Viswanathan, the splines 714 are tethered together via the distal cap 712 at the distal end of the basket, [0106]).
Regarding claim 13, the combination teaches the method according to claim 11, wherein the spines are electrically-connected to one another at a proximal end of the basket assembly (Viswanathan, wherein the splines 714 are coupled together at the distal end of the shaft 710, which is also the proximal end of the basket assembly, [0106]).
Regarding claim 14, the combination teaches the method according to claim 11, and comprising applying an ablation signal using the distributed electrode (Viswanathan, where the splines 714 are electrically conductive and used to supply ablation energy, [0106]).
Regarding claim 15, the combination teaches the method according to claim 11, wherein at least one spine mounted electrode comprising a through hole (from Smith, see mounted electrode 30 with through hole, fig 2) protrudes radially outward from the spines so as to prevent the distributed electrode from indenting the tissue (Govari , diagnostic electrode 50 comes in contact with the surrounding tissue and blood wherein the splines 45 only come in contact with the surrounding blood, [0052], see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not, therefore there is no indenting of the tissue).
Regarding claim 16, the combination teaches the method according to claim 11, wherein at least one spine mounted electrode comprises (Govari , see electrodes 50 mounted on the surface of the spines 45 in fig 2A) a given thickness protruding externally to the spines greater than a thickness protruding internally to the spines (Govari , see also the gap between the electrode surface 50 and spline surface 45 in Fig 3, the electrodes come in contact with the tissue and the splines do not as they protrude externally past the spines).
Regarding claim 17, the combination teaches a method for operating a medical probe, the method comprising: producing a basket assembly (Viswanathan, wherein the set of splines 714 creates the basket assembly, [0106]), comprising: multiple electrically-conductive spines that are electrically-connected to one another so as to form a distributed electrode (Govari , see [0034] in which all the spines 30 are connected to the IRE generator 36 through central wiring inside the insertion tube 28, and therefore by definition create a distributed electrode); and each of the multiple electrically- conductive spines comprising at least one spine mounted electrode comprising a through hole which are disposed along each of the electrically- conductive spines such that each of the electrically-conductive spines is inserted into the through hole of the at least one spine mounted electrode (see Smith fig 2, as well as [0038] in which it is disclosed that the common electrode 30, or mounted electrode is joined and attached through the strut electrode 28, or conductive spines. In which it can be seen in fig 2 that the common electrode 30 is mounted on the strut electrode 28 via a hole through the middle of the electrode 30), the at least one spine mounted electrode being insulated from the electrically conductive spine (Viswanathan, see wherein the individual electrode leads for each electrode 716 may be comprised of insulation material to isolate the electrode from the spline, [0106]); and delivering ablative energy to either one or both of the distributed electrode and at least one spine mounted electrode (Viswanathan, where the splines 714 are electrically conductive and used to supply ablation energy, [0106]).
Regarding claim 18, the combination teaches the method of claim 17, wherein the delivering of ablative energy to the at least one spine mounted electrode includes configuring the distributed electrode as a return electrode (Viswanathan, wherein the set of splines containing the distributed electrode may also be comprised of return electrodes as well, [0332]).
Regarding claim 19, the combination teaches the method of claim 17, wherein the delivering of the ablative energy to distributed electrode includes configuring at least one spine mounted electrode as return electrodes (Viswanathan, wherein the set of splines containing the distributed electrode may also be comprised of return electrodes as well, [0332]).
Regarding claim 20, the combination teaches the method of claim 17, further comprising a central electrode mounted on a member disposed inside the spines along a longitudinal axis of the distributed electrode (Govari , see fig 2A in which the reference electrode 55 is disposed within the interior edge of the spine 45 which extends from the longitudinal axis of the tubular shaft 22).
Regarding claim 21, the combination teaches the method according to claim 17, wherein the ablative energy comprises a pulsed field (Viswanathan, wherein the system contains the generation of pulsed electric fields for therapeutics and ablation, [0002]).
Regarding claim 22, the combination teaches the method according to claim 17, wherein the ablative energy to the spine mounted electrodes (Govari , see [0061], in which it states that the PCB electrodes used in the disclosure as the diagnostic electrodes 50 can also be used for ablating tissue cells) and comprises pulsed field delivered to a plurality of spine mounted electrodes in sequence (Viswanathan, wherein the system contains the generation of pulsed electric fields for therapeutics and ablation, [0002], see further in [0035] describing how different ablation pulses are sent out to the splines in sequential order).
Regarding claim 23, the combination teaches the medical probe according to claim 5, wherein a portion of the at least one spine mounted electrode comprising the through hole (from Smith, mounted electrode 30, fig 2) protrudes radially inward toward the longitudinal axis with a first thickness and radially outward away from the longitudinal axis with a second thickness, the second thickness being greater than the first thickness (see Smith, wherein the spacer struts 26 which are part of the mounted electrode assembly extend out further radially outward than they do inwardly in order to keep the electrode a predetermined distance from the treatment wall, [0039]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US Patent No 20210282847) in view of Govari (US Patent No 20200129125) further in view of Smith (US Patent No 20130090651) further in view of Olson (US Patent No 20190282116).
Regarding claim 9, the previous combination of Viswanathan and Govari teaches the end effector of claim 7.
The combination does not teach further comprising an irrigation member extending from the distal portion of the tubular shaft.
However, irrigation members are commonly known in the art when using ablation techniques as seen in the analogous sensing and ablation basket catheter of Olson which does teach an irrigation member extending from the distal portion of the tubular shaft (the shaft 109 includes a lumen 135 for delivering wiring and irrigation members while in use, [0069]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the sensing and ablation basket catheter defined by Viswanathan, Govari, and Smith to contain an irrigation member as to distribute waste and keep the cavity from piling up waste as disclosed by Olson, [0084].
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
With regards to the applicant argument that neither of the prior art of record references of Viswanathan, Govari, nor smith teach the limitation of “multiple electrically conductive spines that are electrically connected to one another as to form a distributed electrode,” as stated in the independent claims 1, 7, 11 and 17 have been considered but ultimately fall unpersuasive. Although reasonable consideration has been given to the applicant remarks which were made regarding the previous non-final rejection, the examiner would like to remind applicant that all of the claim limitations as presented are analyzed under the broadest reasonable interpretation when applying search and consideration. Therefore, as it is analyzed under the broadest reasonable interpretation, the limitation of “multiple electrically conductive spines that are electrically connected to one another as to form a distributed electrode,” is maintained as being taught by Viswanathan. Viswanathan discloses multiple splines 714 and that the spline structure or assembly 714 contains sets of spline wires 718 and 719 which are electrically conductive, and connect to the spline electrodes 176 which are found on the spline assembly, [0106]. Therefore, Viswanathan teaches the first part of the limitation that there are multiple electrically conductive splines present as the spline structure contains the conductive spline wires 718 and 719. Viswanathan then continues on to teach that the spline wires 718 and 719 include individual sets of spline wires 720, 721, 722, 723 which form a continuous conductive loop between all of the electrodes 716 and with the other set of spline electrodes 716’ which are found on a different spline assembly 714. Therefore, as all of the spline electrodes 716 and 716’ are conductively and electrically connected, they too form a distributed electrode between the spline structures 714 as analogously claimed. Therefore, the prior art of Viswanathan teaches the secondary limitation of the spines being electrically connected to one another as to form a distributed electrode. Therefore, as the prior art of Viswanathan teaches the claim limitation as analyzed under the broadest reasonable interpretation, the independent claims 1, 7, 11 and 17 remain rejected under the prior art of record rejection of Viswanathan in view of Govari further in view of Smith set forth in the previous office action.
All other claims remain rejected under the previous prior art of record rejection set forth due to their dependency on the independent claims 1, 7, 11 and 17.
Conclusion
THIS ACTION IS MADE FINAL. 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 KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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 on 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794