CTNF 18/920,475 CTNF 93151 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 18-20 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 18 recites the limitation "an electrosurgical generator" in line 4. It is unclear to the examiner if the Applicant is referring to the electrosurgical generator that was mentioned in line 2 or a new one. For examination purpose, the examiner is interpreting it to be the same. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1, 4-10, 12-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (US 20230093231) in view of Oyatsu (US 2008/0027429) . Regarding claim 1 , Howard discloses an electrosurgical device for use with a radiofrequency (RF) energy source to provide RF energy (fig.14A-C; see also 14A-C), the electrosurgical device comprising: a delivery component (fig.14A-C; sheath 82) having an elongate shaft (fig.14A-C; elongated shaft of sheath 82) having a distal portion (fig.14A-C; distal portion sheath 82) and a proximal portion (proximal portion of sheath 82) and forming a lumen (fig.2; sheath 82), the distal portion including a delivery component distal end (fig.14A-C; distal end of taper 85, see also [0121]-[0124]); a crossing member (fig.14A-C; needle 12) disposed within the lumen (fig.14A-C), the crossing member having a crossing member distal tip (fig.14A-C; electrode tip 24) extendable from the delivery component distal end and configured to deliver the RF energy from the RF energy source (fig.14A-C, see also [0031]); a handle (fig.6; handle assembly 100) coupled to the proximal portion of the shaft (fig.14A-C). However, Howard does not disclose an actuator coupled to the handle, the actuator configured to extend the crossing member distal tip from the delivery component distal end and actuator that couple the RF energy source to the crossing member, such that RF energy is delivered to the distal tip of the crossing member. Oyatsu teaches electrosurgical treatment system comprising a handle section that is coupled to a base of the flexible sheath and that advances and retracts the electrosurgical knife at a tip of the flexible sheath (fig.14, see also [0061]-[0063]), the actuator configured to extend the crossing member distal tip from the delivery component distal end [0061]-[0063]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Howard with an actuator that couple the RF energy source to the crossing member, such that RF energy is delivered to the distal tip of needle as taught Oyatsu for the purpose of selectively providing RF energy to the distal end of the device. Regarding claim 4 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the actuator includes an advancement mechanism and an RF delivery circuit, wherein activation of the actuator into a first position extends the crossing member and wherein activation of the actuator into a second position from the first position delivers the RF energy to the extended crossing member ([0061]-[0063] of Oyatsu). Regarding claim 5 , Howard/ Oyatsu teaches the electrosurgical device of claim 4, wherein the advancement mechanism is configured to lock the extended crossing member in place relative to the delivery component distal end ([0039] of Oyatsu). Regarding claim 6 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the actuator includes one of a pushbutton, slide mechanism, and trigger ([0061]-[0063] of Oyatsu). Regarding claim 7 , Howard/ Oyatsu teaches the electrosurgical device of claim 6, wherein the actuator further includes a linkage coupled to the one of the pushbutton, slide mechanism, and trigger and to the crossing member ([0061]-[0063] of Oyatsu). Regarding claim 8 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the actuator includes a first actuator coupled to an advancement mechanism configured to extend the crossing member and a second actuator is coupled to an RF delivery circuit configured to deliver the RF energy to the extended actuator ([0061]-[0063] of Oyatsu). Regarding claim 9 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the delivery component is a dilator, and the delivery component distal end includes a dilator tip (fig.14A-C, see also [0121]-[0123] of Howard). Regarding claim 10 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the delivery component is a delivery sheath (fig.14A-C, see also [0061]-[0063] of Howard). Regarding claim 12 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, further including an auxiliary sheath having a lumen for accepting the delivery component (fig.14A-C). Regarding claim 13 , Howard discloses an electrosurgical assembly for use with an electrosurgical generator, the electrosurgical assembly comprising: an introducer (fig.14A-C; sheath 82) having an introducer handle (fig.14A-C; sheath handle 83) and an elongate sheath forming an introducer lumen (fig.14A-C; lumen of sheath 82); and an integrated transseptal device (fig.14A-C; dilator 84), comprising: an elongate shaft (an elongate shaft of dilator 84) disposed within the introducer lumen (fig.14A-C), the elongate shaft having a distal end (fig.14A-C; tapered dilator tip 85) and a proximal end (fig.14A-C; proximal end of sheath 82) and forming a device lumen (the lumen of dilator body 34), the distal end including a dilator tip (the tip of dilator body 34), a crossing member (fig.14A-C; needle 12) disposed within the device lumen [0122]-[0124], the crossing member having a distal tip extendable from the dilator tip and configured to apply a radiofrequency (RF) signal (fig.14A-C, see also[0121]), a device handle (fig.14A-C; needle handle 26) coupled the introducer handle [0124], the device handle attached to the shaft at the proximal end (fig.14A-C). However, Howard does not disclose an actuator coupled to the device handle, the actuator configured to extend the distal tip of the crossing member from the dilator tip and deliver the RF signal to the extended crossing member. Oyatsu teaches electrosurgical treatment system comprising a handle section that is coupled to a base of the flexible sheath and that advances and retracts the electrosurgical knife at a tip of the flexible sheath; and Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Howard with an actuator that couple the RF energy source to the crossing member, such that RF energy is delivered to the distal tip of needle as taught Oyatsu for the purpose of selectively providing RF energy to the distal end of the device. Regarding claim 14 , Howard/ Oyatsu teaches the electrosurgical assembly of claim 13, wherein the device handle is electrically coupled to the introducer handle ([0061]-[0063] of Oyatsu). Regarding claim 15 , Howard/ Oyatsu teaches the electrosurgical assembly of claim 13, wherein the crossing member is hollow and receives a guidewire (fig.14A-C, see also [0045] of Howard). Regarding claim 16 , Howard/ Oyatsu teaches the electrosurgical assembly of claim 13, wherein the actuator provides a signal to the electrosurgical generator to request RF energy (fig.14, see also [0061] of Oyatsu). Regarding claim 18 , Howard discloses an electrosurgical system comprising: an electrosurgical generator configured to provide a source of radiofrequency (RF) energy as an RF signal [0011]-[0013]; and an electrosurgical assembly for use with an electrosurgical generator (fig.14A-C), the electrosurgical assembly comprising: an introducer (fig.14A-C; sheath 82) having an introducer handle (fig.14A-C; sheath handle 83) and an elongate sheath (elongate sheath 82) forming an introducer lumen (fig.14A-C); and an integrated transseptal device (dilator 84), comprising; an elongate shaft (elongate shaft of dilator 84) disposed within the introducer lumen (fig.14A-C), the elongate shaft having a distal end (distal portion of dilator 84) and a proximal end (proximal end of dilator 84) and forming a device lumen (fig.14A-C), the distal end including a dilator tip (dilator tip 85), a crossing member (fig.14A-C; RF needle 12) disposed within the device lumen, the crossing member having a distal tip (electrode tip 24) extendable from the dilator tip and configured to apply the RF signal [0122]-[0123], a device handle (fig.14A-C; needle handle 26) coupled the introducer handle (fig.14A-C; see also [0122]), the device handle attached to the shaft at the proximal end (fig.14A-C). However, Howard does not an actuator coupled to the device handle, the actuator configured to extend the distal tip of the crossing member from the dilator tip and deliver the RF signal to the extended crossing member. Oyatsu teaches electrosurgical treatment system comprising a handle section that is coupled to a base of the flexible sheath and that advances and retracts the electrosurgical knife at a tip of the flexible sheath (fig.14, see also [0061]-[0063]), the actuator configured to extend the crossing member distal tip from the delivery component distal end [0061]-[0063]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Howard with an actuator that couple the RF energy source to the crossing member, such that RF energy is delivered to the distal tip of needle as taught Oyatsu for the purpose of selectively providing RF energy to the distal end of the device. Regarding claim 19 , Howard/ Oyatsu teaches the electrosurgical system of claim 18, wherein the device handle is electrically coupled to the introducer handle ([0061]-[0063] of Oyatsu). Regarding claim 20 , Howard/ Oyatsu teaches the electrosurgical system of claim 18, wherein the actuator provides a signal to the electrosurgical generator to request the RF energy ([0061]-[0063] of Oyatsu) . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (US 2023/0093231) in view of Oyatsu (US 2008/0027429) in further view of Kimmel et al. (US 2013/0304036) . Regarding claim 11 , Howard/ Oyatsu teaches the electrosurgical device of claim 1, wherein the actuator includes one of a slide mechanism ([0061]-[0063] of Oyatsu). However, Howard/ Oyatsu does not teach a spring-loaded mechanism in the handle, the slide mechanism and spring-loaded mechanism configured to extend the crossing member. Kimmel teaches an apparatus comprising a transseptal needle assembly including a handle assembly includes sliding mechanism and spring that configured to inhibit from sliding forward with respect to the distal handle [0077]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Howard/ Oyatsu with a spring in the handle configured to control the movement of the needle as taught by Kimmel for the purpose controlling the movement of the needle as desired . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 2-3 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 2 and 17, None of the references teach a time delay circuit configured to deliver the RF energy, wherein the activation of the actuator delivers the RF energy after a selected time delay after the crossing member distal tip is extended. Claim 3 depends on claim 2 and therefore are objected . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm. 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, Joseph Stoklosa can be reached at 571-2721213. 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. /TIGIST S DEMIE/Primary Examiner, Art Unit 3794 Application/Control Number: 18/920,475 Page 2 Art Unit: 3794 Application/Control Number: 18/920,475 Page 3 Art Unit: 3794 Application/Control Number: 18/920,475 Page 4 Art Unit: 3794 Application/Control Number: 18/920,475 Page 6 Art Unit: 3794 Application/Control Number: 18/920,475 Page 7 Art Unit: 3794 Application/Control Number: 18/920,475 Page 8 Art Unit: 3794 Application/Control Number: 18/920,475 Page 9 Art Unit: 3794 Application/Control Number: 18/920,475 Page 10 Art Unit: 3794
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