DETAILED ACTION
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 4, 2026 has been entered.
Claim Objections
Claim 17 is objected to because of the following informalities: in line 1, “system m accordance” should be replaced with -system in accordance-. 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) 1, 5-11, 15-23, and 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan, U.S. 2019/0231421 (hereinafter Viswanathan) in view of Steinke, U.S. 2005/0096647 (hereinafter Steinke), Harlev, U.S. 10,105,179 (hereinafter Harlev), and Govari, U.S. 2022/0110675 (hereinafter Govari).
Regarding claims 1, 5, 11, 15, and 20-22, Viswanathan discloses (note figs. 39A-D; paragraphs 272-275) an electroporation system comprising: a generator (note paragraph 68); and a catheter coupled to the generator, the catheter comprising: a handle (note paragraph 272); a shaft (3910) extending distally from the handle; a plurality of splines (3930) forming a basket ‘coupled to’ the shaft, each spline extending between a proximal end and a distal end; wherein each spline of the plurality of splines comprises at least one energizable electrode (3932/3934), wherein each spline comprises a body having the at least one energizable electrode thereon, and wherein, for each spline, a proximal portion of the spline extending from the proximal end is necessarily electrically insulative (see portions of spline without electrodes); and a balloon (3950) positioned within the basket formed by the plurality of splines. However, Viswanathan fails to explicitly disclose that each spline comprises a body fabricated from an elastic conductive material, along with an insulating material covering portions of the body, wherein at least one exposed portion of the body functions as the at least one energizable electrode. Steinke teaches a similar expandable catheter, wherein each spline comprises a body fabricated from an elastic conductive material along with an insulating material covering portions of the body, wherein at least one exposed portion of the body functions as an energizable electrode (note paragraph 16). It is well known in the art that these different ‘spline-electrode’ configurations (i.e., separate mounted electrodes vs integral exposed electrodes) are widely considered to be interchangeable (as can be seen in the different embodiments of Steinke). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Viswanathan to comprise the claimed ‘exposed electrode’ configuration (as taught by Steinke). This is because this modification would have merely comprised a simple substitution of interchangeable ‘spline-electrode’ configurations in order to produce a similar result (see MPEP 2143). This combination of references still fails to expressly teach a tapered member corresponding to this at least one electrode, said tapered member comprising a first end and a second end with a tapered portion therebetween, said tapered portion comprising a first tapered portion, a second portion, and a constant-width middle portion having an arcuate shape. However, Harlev teaches (note fig. 6) a similar expandable catheter comprising splines with tapered energy delivery regions (144b) thereon. It is well known in the art that these different ‘energy delivery’ configurations (i.e., shapes) are widely considered to be interchangeable (as can be seen in the different embodiments of Harlev). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Viswanathan to comprise the claimed ‘tapered electrode’ configuration (as taught by Harlev). This is because this modification would have merely comprised a simple substitution of interchangeable ‘energy delivery’ configurations in order to produce a predictable result (see MPEP 2143). This combination of references still fails to expressly teach a shaft comprising at least one magnetic sensor positioned proximate an end of the balloon. However, Govari teaches a similar expandable catheter comprising at least one magnetic sensor positioned on a shaft proximate an end of the balloon (note paragraphs 55-56). This configuration enables the position/direction of the catheter balloon to be determined, thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Viswanathan to comprise at least one magnetic sensor positioned on the shaft proximate an end of the balloon (as taught by Govari), in order to increase safety and efficiency. It should be noted that the method of claim 20 would necessarily be met through the routine assembly of this device (see above).
Regarding claims 6, 7, 9, 16, 17, and 19, Viswanathan discloses (see above) an electroporation system wherein the shaft comprises: an outer shaft element (3910); and an inner shaft element (3921) extending through the outer shaft element, wherein the distal end of each spline is operatively connected to a distal end of the inner shaft element (note paragraph 273), wherein the proximal end of each spline is connected to a distal end of the outer shaft element (note paragraph 273), and wherein the inner shaft element is slidable relative to the outer shaft element to adjust an effective diameter of the basket formed by the plurality of splines (note paragraph 274); wherein sliding the inner shaft element distally relative to the shaft element necessarily decreases the effective diameter, and wherein sliding the inner shaft element proximally relative to the shaft element necessarily increases the effective diameter; and wherein a channel (disposed within ‘3920’) is defined between the inner shaft element and the outer shaft element, the channel in fluid communication with an interior of the balloon to facilitate selectively inflating the balloon using a fluid (note paragraph 286).
Regarding claims 6, 8, 16, and 18, Viswanathan discloses (see above) an electroporation system wherein the shaft comprises: an outer shaft element (3910); and an inner shaft element (3920) extending through the outer shaft element, wherein the distal end of each spline is ‘operatively connected’ to a distal end of the inner shaft element (note paragraphs 273 and 286), wherein the proximal end of each spline is connected to a distal end of the outer shaft element (note paragraph 273), and wherein the inner shaft element is slidable relative to the outer shaft element to adjust an effective diameter of the basket formed by the plurality of splines (note paragraph 286); and wherein the inner shaft element defines a central lumen (note paragraph 286), the central lumen capable of receiving at least one of contrast agent, a mapping catheter, a guidewire, and a shape sensing fiber.
Regarding claim 10, Viswanathan discloses (see above) an electroporation catheter wherein alternating splines have electrodes with alternating polarities (note paragraph 293).
Regarding claim 23, Viswanathan in view of Steinke, Harlev, and Govari teaches (see above) an electroporation catheter having splines with exposed tapered electrodes therealong. However, this combination of references fails to expressly teach that these tapered electrodes are closer to the distal ends of their respective splines. A different embodiment of Viswanathan teaches (note fig. 28) splines having electrodes thereon that are closer to the distal ends of their respective splines. It is well known in the art that these different ‘spline-electrode’ configurations (i.e., different positions of electrodes along the splines) are widely considered to be interchangeable (as can be seen in the different embodiments of Viswanathan). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Viswanathan to comprise electrodes that are disposed anywhere along their respective splines (including closer to the distal ends of their respective splines). This is because this modification would have merely comprised a simple substitution of interchangeable ‘spline-electrode’ configurations in order to produce a predictable result (see MPEP 2143).
Regarding claims 25, 27, and 29, Viswanathan in view of Steinke, Harlev, and Govari necessarily teaches (see above) an electroporation catheter wherein the tapered portion forms a portion of the at least one exposed portion such that circumferential gaps between the plurality of splines are reduced. It should be noted that the method of claim 29 would necessarily be met through the routine assembly of this device (see above).
Regarding claims 26, 28, and 30, Viswanathan in view of Steinke, Harlev, and Govari necessarily teaches (see above) an electroporation catheter wherein for each spline, an ‘inflection point’ is defined along the spline (e.g., between the proximal and distal groupings of electrodes in Viswanathan), and (some) portions of the spline distal of the inflection point (see ‘electrodes’) are exposed while (some) portions proximal of the inflection point (see portions of spline without exposed electrodes) are covered by the insulating material. It should be noted that the method of claim 28 would necessarily be met through the routine assembly of this device (see above).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2009/0248012 (Maor).
U.S. 2017/0049500 (Shikhman).
U.S. 2022/0022954 (Shuros).
U.S. 6,142,993 (Whayne).
U.S. 6,036,689 (Tu).
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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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.
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
Prosecution Insights