CTNF 18/437,600 CTNF 93151 DETAILED ACTION 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of species B (claims 1-6, 8 and 13-18) in the reply filed on 03/25/2026 is acknowledged. 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 7 and 13-14 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. 07-34-05 AIA Claim 7 recites the limitation " the electrical insulating material " in line 5 . There is insufficient antecedent basis for this limitation in the claim. 07-34-05 AIA Claim 13 recites the limitation " the radiofrequency generator " in line 4 . There is insufficient antecedent basis for this limitation in the claim. 07-34-05 AIA Claim 14 recites the limitation " the radiofrequency generator " in line 2 . There is insufficient antecedent basis for this limitation in the claim. 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 1-6, 8, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Long (US 2014/0039492) . Regarding claim 1 , Long discloses a transseptal access system comprising: a radiofrequency perforation device (fig.1-2; first elongate body 20) having a proximal portion (the proximal portion of first elongate body 20) having a proximal portion length (fig.1-2), and a distal portion (distal portion first elongate body 20) having a distal portion length (fig.1-2), the proximal and distal portion lengths defining a perforation device length (fig.1-2), wherein the proximal portion has an electrically insulated outer surface (fig.2; insulative sleeve 24), and wherein the distal portion is electrically conductive (electrode 50, see also [0042], “The insert 26 may also transmit energy to the electrically conductive portion 54 at an interface of the distal end of the sheath 42 and the electrode 50. In one embodiment, the insert 26 transmits electrical energy to the electrically conductive portion 54 within a bore 56 (indicated in FIG. 3) defined within the electrode 50”) and terminates at a functional tip (tip 52, see [0042]), and wherein at least part of the distal portion is uninsulated [0044]; and a tubular dilator (fig.4; sheath 42) comprising an elongated body having a body length (body length of sheath 42), a proximal end (proximal end of sheath 42) and a distal end portion (distal end portion of sheath 42) terminating in a distal tip (distal end of sheath 42), a hub (distal mating element 48) at the proximal end of the body (fig.1-2) and having a hub length (fig.1-2), a dilator lumen (lumen sheath 42) extending through the hub and the body and being dimensioned to slidingly receive the radiofrequency perforation device (fig.4, see also [0042]), and an electrical contact element disposed within the hub adjacent to the dilator lumen [0044], wherein the body length and the hub length together define a dilator length (fig.1-2), wherein the perforation device length is greater than the dilator length (fig.1-2, see also [0042]), and wherein the proximal portion length and the distal portion length are further dimensioned such when the radiofrequency perforation device is in the first position the electrical contact element is in electrical engagement with the distal portion of the radiofrequency perforation device [0042]. However, in this embodiment (fig.1-2), Long does not disclose wherein the proximal portion length and the distal portion length are dimensioned such that when the radiofrequency perforation device is at a first position within the dilator lumen with the functional tip adjacent to or extending distally from the distal tip of the dilator, no portion of the distal portion of the radiofrequency perforation device extends proximally of the hub. In another embodiment (fig.4), Long wherein the proximal portion length and the distal portion length are dimensioned such that when the radiofrequency perforation device is at a first position within the dilator lumen with the functional tip adjacent to or extending distally from the distal tip of the dilator (fig.4, see also [0044]: “in some embodiments, the insert 26 may also comprise a retractable portion that may be operatively coupled to the electrode 50 such that retraction or extension (e.g., by rotation or slide about tracks) of the insert 26 also retracts the electrode 50 and extension of the insert 26 extends the electrode 50 relative to the distal end of the sheath 42. Accordingly, in the embodiment illustrated in FIG. 4”), no portion of the distal portion of the radiofrequency perforation device extends proximally of the hub (fig.1). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to combined the two embodiments to include the proximal portion length and the distal portion length are dimensioned such that when the radiofrequency perforation device is at a first position within the dilator lumen with the functional tip adjacent to or extending distally from the distal tip of the dilator in order to have adjustable distal tip in order to achieve the desired treatment. Regarding claim 2 , Long discloses the transseptal access system of claim 1, wherein the proximal portion and the distal portion of the radiofrequency perforation device are substantially isodiametric (fig.4). Regarding claim 3 , Long discloses the transseptal access system of claim 1, wherein the dilator lumen has a dilator lumen diameter, and the electrical contact element has a flexible contact member (spring, see [0044]) defining an electrical contact element inner diameter that is smaller than the dilator lumen diameter such that the contact member extends partially into the dilator lumen [0044]. Regarding claim 4 , Long discloses the transseptal access system of claim 3, wherein the contact member is deformable so as to maintain electrical engagement with the distal portion of the radiofrequency perforation device when the radiofrequency perforation device is in the first position [0044]. Regarding claim 5 , Long discloses the transseptal access system of claim 1, wherein the proximal portion of the radiofrequency perforation device comprises an electrical insulating material forming the electrically insulated outer surface (fig.1; insulative sleeve 24), and wherein proximal portion of the radiofrequency perforation device is formed entirely of the electrical insulating material [0046]. Regarding claim 6 , Long discloses the transseptal access system of claim 1, wherein the proximal and distal portions of the radiofrequency perforation device are mechanically joined to one another (fig.1). Regarding claim 8 , Long discloses the transseptal access system of claim 1, wherein the proximal portion of the radiofrequency perforation device is configured to be manipulated by a user during operation of the system [0044]. Regarding claim 13 , Long discloses the transseptal access system of claim 1, wherein the dilator further comprises a connection port (“A terminal or other contact surfaces of the spring may contact the insert 26 or distal mating element 48 and transmit energy to electrode 50 therefrom”, see [0044]) and an electrical lead coupling the electrical contact element and the connection port, wherein the connection port is configured to electrically couple the electrical contact element to the radiofrequency generator [0044]. Regarding claim 14 , Long discloses the transseptal access system of claim 1, wherein when the radiofrequency perforation device is in the first position, the radiofrequency generator is configured to deliver radiofrequency energy to the functional tip [0044]. Regarding claim 15 , Long discloses a transseptal access system assembly using radiofrequency energy, the transseptal access system comprising: a radiofrequency perforation device (first elongate body 20) having a proximal portion (proximal portion of first elongate body 20) having a proximal portion length (fig.2), and a distal portion having a distal portion length, and a tabulator dilator (sheath 42) comprising an elongated body (elongated body sheath 42) having a proximal end (proximal end sheath 42) and a distal end portion (distal end sheath 42) terminating in a distal tip (distal tip sheath 42), a hub (distal mating element 48) at the proximal end of the body (fig. 1 and 4), a dilator lumen (bore 46) extending through the hub and the body and being dimensioned to slidingly receive the radiofrequency perforation device [0044], and an electrical contact element disposed within the hub adjacent to the dilator lumen [0044], the electrical contact element having a flexible contact member (“A terminal or other contact surfaces of the spring may contact the insert 26 or distal mating element 48”,see [0044]), wherein the perforation device length is greater than the dilator length, and wherein the proximal and distal portions of the radiofrequency perforation device mechanically joined to one another (fig.2). However, Long does not disclose the electrical contact element having a flexible contact member, wherein the perforation device length is greater than the dilator length, and wherein the proximal and distal portions of the radiofrequency perforation device mechanically joined to one another. In another embodiment (fig.4, see also [0044]), Long teaches the electrical contact element having a flexible contact member (“A terminal or other contact surfaces of the spring may contact the insert 26 or distal mating element 48”, see [0044]), wherein the perforation device length is greater than the dilator length, and wherein the proximal and distal portions of the radiofrequency perforation device mechanically joined to one another (fig.4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to combined the two embodiments to include electrical contact element having a flexible contact member in order to couple the proximal and distal portion of the device easily. Regarding claim 16 , Long discloses the transseptal access system of claim 15, wherein the proximal portion length and the distal portion length are dimensioned such that when the radiofrequency perforation device is at a first position within the dilator lumen with the functional tip adjacent to or extending distally from the distal tip of the dilator, no portion of the distal portion of the radiofrequency perforation device extends proximally of the hub (fig.1) Regarding claim 17 , Long discloses the transseptal access system of claims 16, wherein the proximal portion length and the distal portion length are further dimensioned such when the radiofrequency perforation device is in the first position the electrical contact element is in electrical engagement with the distal portion of the radiofrequency perforation device [0044]. Regarding claim 18 , Long discloses the transseptal access system of claim 15, wherein the proximal portion of the radiofrequency perforation device is configured to be manipulated by a user during operation of the system [0044]. 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. 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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: 18/437,600 Page 2 Art Unit: 3794 Application/Control Number: 18/437,600 Page 3 Art Unit: 3794 Application/Control Number: 18/437,600 Page 4 Art Unit: 3794 Application/Control Number: 18/437,600 Page 5 Art Unit: 3794 Application/Control Number: 18/437,600 Page 6 Art Unit: 3794 Application/Control Number: 18/437,600 Page 7 Art Unit: 3794 Application/Control Number: 18/437,600 Page 8 Art Unit: 3794 Application/Control Number: 18/437,600 Page 9 Art Unit: 3794
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