CTNF 18/805,811 CTNF 76942 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims 2. Claims 1-20 as originally filed on 08/15/2024 are pending, and have been examined on the merits. Claim Rejections - 35 USC § 112 3. 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. 4. Claim 20 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention . 5. In claim 20 , there is insufficient antecedent basis for the recitation of “wherein instructions to generate the alert include…” in line 1. It is noted that claim 20 ultimately depends from independent claim 17. Independent claim 11, however, is the claim that includes limitations directed to the storage/execution of instructions. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA 7. Claim s 1-3, 6, 8, 11, 12, & 17 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by U.S. Patent Application Publication No. 2022/0257313 to Davies et al . (“Davies”) . 8. Regarding claim 1 , Davies discloses a transeptal surgical system configured to puncture an atrial septum within a heart of a patient, the transseptal surgical system comprising: an electrosurgical device configured to couple to a radiofrequency (RF) energy source [RF generator (114) - ¶[0049]; FIG. 1], the electrosurgical device comprising: a delivery component [dilator (102) - ¶[0050]; FIG. 2] having an elongate shaft [elongate member (118) - ¶[0050]; FIG. 2] defining a longitudinally extending lumen [lumen (130) - ¶[0050]; FIGS. 3B-3C] and a delivery component distal tip [dilating tip (134) - ¶[0050]; FIG. 2] having a delivery component electrode [EAM electrode (148) - ¶[0056]; FIG. 2], and a crossing member [RF perforation device (112) - ¶[0049]; FIGS. 11-13] adapted to be disposed within the lumen [(130)] and coupled to the RF energy sourc [(114)] [¶[0049]], the crossing member [(112)] having a crossing member distal tip extendable from the lumen [(130)], the crossing member distal tip having a crossing member electrode [perforation electrode (113) - ¶[0049]]; adapted to deliver the RF energy [¶[0049]]; and an electroanatomical mapping system [EAM system (104) - ¶[0049]; FIG. 1] coupled to the electrosurgical device, the electroanatomical mapping system [(104)] having a tracking component configured to: detect a position of the delivery component electrode [(148)] and the crossing member electrode [(113)] [ e.g ., ¶’s [0073], [0076]], determine a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)] [e.g., ¶[0076]], and generate an alert if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing [ e.g ., ¶[0077] (“ the system 100 can further be configured to provide an alert if the perforation electrode 113 advances distal of the distal end 140 of the dilator 102 ”)]. 9. Regarding claim 2 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies further discloses wherein the delivery component is a dilator [dilator (102) - ¶[0050]; FIG. 2] having a tapered distal portion [¶[0053]; FIGS. 2, 3A], the tapered distal portion including the delivery component distal tip [dilating tip (134) - ¶[0050]; FIG. 2]. 10. Regarding claim 3 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies further discloses an RF generator [RF generator (114) - ¶[0049]; FIG. 1] to provide the RF energy source. 11. Regarding claim 6 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies further discloses wherein the crossing member [RF perforation device (112)] is adapted to deliver the RF energy in a monopolar mode [see, e.g ., the use of grounding pad (116) - ¶[0049]; FIG. 1]. 12. Regarding claim 8 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies further discloses wherein the crossing member distal tip is extendable from the delivery component distal tip [(314)] such that the delivery component is fully retractable over the crossing member [(112)] [ e.g ., ¶’s [0075]-[0076]]. 13. Regarding claim 11 , Davies discloses an electroanatomical mapping system [EAM system (104) - ¶[0049]; FIG. 1] for use with an electrosurgical device to guide a surgical puncture of an atrial septum within a heart of a patient [e.g., ¶’s [0047], [0048], [0073]], the electrosurgical device comprising a delivery component [dilator (102) - ¶[0050]; FIG. 2] having an elongate shaft [elongate member (118) - ¶[0050]; FIG. 2] defining a longitudinally extending lumen [lumen (130) - ¶[0050]; FIGS. 3B-3C] and a delivery component distal tip [dilating tip (134) - ¶[0050]; FIG. 2] having a delivery component electrode [EAM electrode (148) - ¶[0056]; FIG. 2], and a crossing member [RF perforation device (112) - ¶[0049]; FIGS. 11-13] adapted to be disposed within the lumen [(130)], the crossing member having a crossing member distal tip extendable from the lumen, the crossing member distal tip having a crossing member electrode [perforation electrode (113) - ¶[0049]] adapted to deliver a source of RF energy [¶[0049]], the electroanatomical mapping system [(104)] comprising: memory to store a set of instructions [¶[0064]]; and a processor to execute the set of instructions [¶[0064]] to: detect a position of the delivery component electrode [(148)] and the crossing member electrode [(113)] [ e.g ., ¶’s [0073], [0076]], determine a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)] [e.g., ¶[0076]], and generate an alert if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing [ e.g ., ¶[0077] (“ the system 100 can further be configured to provide an alert if the perforation electrode 113 advances distal of the distal end 140 of the dilator 102 ”)]. 14. Regarding claim 12 , Davies discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action. Davies discloses wherein the set of instructions further includes instructions to receive the specified protrusion spacing from a user input [it is the Examiner’s position that this limitation is implicitly satisfied when the system is initially “configured” to provide the protrusion alert - ¶[0077]]. 15. Regarding claim 17 , Davies discloses a process to guide an electrosurgical device in a surgical puncture of an atrial septum within a heart of a patient [ e.g ., ¶’s [0047], [0048], [0073]], the electrosurgical device comprising a delivery component [dilator (102) - ¶[0050]; FIG. 2] having an elongate shaft [elongate member (118) - ¶[0050]; FIG. 2] defining a longitudinally extending lumen [lumen (130) - ¶[0050]; FIGS. 3B-3C] and a delivery component distal tip [dilating tip (134) - ¶[0050]; FIG. 2] having a delivery component electrode [EAM electrode (148) - ¶[0056]; FIG. 2], and a crossing member [RF perforation device (112) - ¶[0049]; FIGS. 11-13] adapted to be disposed within the lumen [(130)], the crossing member having a crossing member distal tip extendable from the lumen, the crossing member distal tip having a crossing member electrode [perforation electrode (113) - ¶[0049]] adapted to deliver a source of RF energy [¶[0049]], the process comprising: detecting a position of the delivery component electrode [(148)] and the crossing member electrode [(113)] [ e.g ., ¶’s [0073], [0076]] with an electroanatomical mapping system [EAM system (104) - ¶[0049]; FIG. 1] electrically coupled to the electrosurgical device; determining a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)] [e.g., ¶[0076]] with the electroanatomical mapping system [(104)]; and generating an alert with the electroanatomical mapping system [(104)] if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing [ e.g ., ¶[0077] (“ the system 100 can further be configured to provide an alert if the perforation electrode 113 advances distal of the distal end 140 of the dilator 102 ”)] . Claim Rejections - 35 USC § 103 07-20-aia AIA 16. 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 17. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 18. Claim s 9, 10, 13, 16, & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Davies . 19. Regarding claim 9 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies further teaches wherein the delivery component includes an orientation electrode [electrode (748b) - ¶[0071]; FIG. 7], and the tracking component is further configured to: detect a position of the orientation electrode [(748b)] [¶[0071]]; & define an axis of the delivery component [dilator] to include the position of the delivery component electrode [EAM electrode (148)] and the orientation electrode [(748b)] [see ¶[0071] (“ The use of additional EAM electrodes can allow for additional location data to be determined. For example, the location of the sheath 710, or the location dilating tip 734 with respect to the sheath 710, can be determined. Additionally, by providing additional electrodes, the orientation of the sheath or dilator may be determined. For example, providing at least two electrodes on each of the sheath and dilator allows the determination of the direction in which the devices are oriented ”)]. Davies does not, however, explicitly disclose that the tracking component is further configured to: generate the alert if the crossing member electrode [perforation electrode (113)] is extended from the delivery component electrode [EAM electrode (148)] at the specified protrusion spacing and the detected position of the crossing member electrode [(113)] lies on the axis of the delivery component [dilator (102)]. However, given that Davies is already concerned with determining the orientation of the combined assembly [see ¶[0076]], it is the Examiner’s position that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Davies such that the protrusion alert be based on the specified protrusion spacing as well as a desired/undesired position/orientation of the crossing member electrode (113), since such a modification would provide the benefit/advantage of enabling a user to determine whether the combined assembly is in a desirable/undesirable configuration based on position and spacing. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, it is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc ., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. 20. Regarding claim 10 , Davies (as modified above) teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action. Davies further teaches wherein the orientation electrode [electrode (748b)] is disposed proximal to the delivery component electrode [EAM electrode (148)] along the elongate shaft (118) [¶[0071]; FIG. 7]. 21. Regarding claim 13 , Davies discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action. Davies does not explicitly disclose: wherein the instructions to generate the alert include instructions to generate the alert based on a congruence of the position of the delivery component electrode [EAM electrode (148)] and the crossing member electrode [perforation electrode (113)] and the specified protrusion spacing. Davies does, however, additionally teach that the delivery component includes an orientation electrode [electrode (748b) - ¶[0071]; FIG. 7], and that the use thereof enables the determination of position/orientation data of the devices [see ¶[0071]]. Given that Davies is already concerned with determining the orientation of the combined assembly [ e.g ., ¶[0076]], it is the Examiner’s position that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Davies such that the protrusion alert be based on the specified protrusion spacing as well as a desired/undesired position/orientation of the devices relative to one another including, e.g ., . a congruence of the position of the delivery component electrode [(148)] and the crossing member electrode [(113)], since such a modification would provide the benefit/advantage of enabling a user to determine whether the combined assembly is in a desirable/undesirable configuration based on position and spacing. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, it is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc ., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. 22. Regarding claim 16 , Davies discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action. Davies does not, however, explicitly disclose wherein the set of instructions further includes instructions to determine the specified protrusion spacing from a set of received surgical parameters related to the electrosurgical device and the heart. However, given that Davies is concerned with proper device positioning within the body and vis-à-vis other tools [ e.g ., ¶[0048]], as well as enhancing the overall safety of the procedure [¶[0073]], it is the Examiner’s position that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Davies such that the protrusion alert be based on parameters related to the electrosurgical device and the heart of the subject/patient, given that the heart size will vary across patients. 23. Regarding claim 18 , Davies discloses all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action. Davies further discloses the specified protrusion spacing from a user input [it is the Examiner’s position that this limitation is implicitly satisfied when the system is initially “configured” to provide the protrusion alert - ¶[0077]]. Davies does not explicitly disclose: wherein generating an alert is based on a congruence of the position of the delivery component electrode [EAM electrode (148)] and the crossing member electrode [perforation electrode (113)] and the specified protrusion spacing from a user input. Davies does, however, additionally teach that the delivery component includes an orientation electrode [electrode (748b) - ¶[0071]; FIG. 7], and that the use thereof enables the determination of position/orientation data of the devices [see ¶[0071]]. Given that Davies is already concerned with determining the orientation of the combined assembly [ e.g ., ¶[0076]], it is the Examiner’s position that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Davies such that the protrusion alert be based on the specified protrusion spacing as well as a desired/undesired position/orientation of the devices relative to one another including, e.g ., . a congruence of the position of the delivery component electrode [(148)] and the crossing member electrode [(113)], since such a modification would provide the benefit/advantage of enabling a user to determine whether the combined assembly is in a desirable/undesirable configuration based on position and spacing. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, it is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc ., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396 . 07-21-aia AIA 24. Claim s 4, 5, & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davies in view of WO 2021/255556 to MacDonald et al . ("MacDonald”) [ made of record in Applicant’s 01/03/25 IDS ] . 25. Regarding claims 4 & 5 , Davies discloses all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action. Davies does not, however, disclose: [ claim 4 ] a switch mechanically coupled to the electrosurgical device, the RF generator, and the electroanatomical mapping system, the switch configured to selectively electrically couple the electrosurgical device to one of the RF generator and the electroanatomical mapping system; nor [ claim 5 ] wherein the switch is configured to selectively electrically couple the crossing member electrode to one of the RF generator and the electroanatomical mapping system. MacDonald, in a similar field of endeavor, is directed to a system comprising an electroanatomical mapping system, an elongated needle assembly, an energy-delivery assembly, and a signal-interface assembly [ e.g ., ¶[01], pg. 1]. MacDonald further teaches that it was known to utilize a switch box [switch] to connect (split) signals between an energy generator and: a distal energy emitter; and the signal-interface assembly [ e.g ., ¶[051], pg. 13; ¶[053], pg. 14; ¶[060], pg. 15; & ¶[063], pg. 16]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Davies to include a switch mechanically coupled to the electrosurgical device, the RF generator, and the electroanatomical mapping system, the switch configured to selectively electrically couple the electrosurgical device to one of the RF generator and the electroanatomical mapping system, and wherein the switch is configured to selectively electrically couple the crossing member electrode to one of the RF generator and the electroanatomical mapping system, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [selective coupling of various system components] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). 26. Regarding claim 7 , Davies discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action. Davies does not, however, disclose: wherein the crossing member [RF perforation device (112)] is configured as a guidewire. MacDonald, in a similar field of endeavor, is directed to a system comprising an electroanatomical mapping system, an elongated needle assembly, an energy-delivery assembly, and a signal-interface assembly [ e.g ., ¶[01], pg. 1]. MacDonald further teaches an energy-delivery assembly (201) and distal-end energy emitter (208) in the form of an RF puncture device, such as an RF guidewire [¶[037], pg. 9]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Davies such that the crossing member [RF perforation device (112)] be configured as a guidewire, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [a guidewire that also serves as an RF puncture/perforation device] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) . 07-21-aia AIA 27. Claim s 14, 15, 19, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies in view of U.S. Patent Application Publication No. 2022/0370121 to Highsmith (“Highsmith”) . 28. Regarding claims 14 & 15 , Davies discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action. Davies does not, however, disclose: [ claim 14 ] wherein instructions to detect the position of the delivery component electrode and the crossing member electrode include instructions to superimpose the position of the delivery component electrode and the crossing member electrode on a graphical representation of the heart; nor [ claim 15 ] wherein instructions to generate the alert include instructions to highlight a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart. Highsmith, in a similar field of endeavor, teaches methods and devices for perforation procedures such as a transseptal perforation procedure [¶[0002]]. Highsmith further teaches that it was known to present images of a cavity, such as an internal chamber of a heart, along with images of the microcatheter and guidewire of the system to allow an operator to visualize characteristics of the cavity, as well as to control aspects of the system [¶’s [0088]-[0091]; FIG. 6]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Davies such that instructions to detect the position of the delivery component electrode and the crossing member electrode include instructions to superimpose the position of the delivery component electrode and the crossing member electrode on a graphical representation of the heart, and wherein instructions to generate the alert include instructions to highlight a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart, since such a modification would provide the benefit/advantage of facilitating a procedure for a practitioner by enabling the practitioner to visualize the location, position, and/or orientation of the device components relative to one another, and to the heart, in real-time, thereby ensuring desired, safe, and effective device positioning. 29. Regarding claims 19 & 20 , Davies (as modified) teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action. Davies does not, however, teach : [ claim 19 ] superimposing the position of the delivery component electrode and the crossing member electrode on a graphical representation of the heart in a display device; & [ claim 20 ] wherein instructions to generate the alert include instructions to highlight a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart. Highsmith, in a similar field of endeavor, teaches methods and devices for perforation procedures such as a transseptal perforation procedure [¶[0002]]. Highsmith further teaches that it was known to present images of a cavity, such as an internal chamber of a heart, along with images of the microcatheter and guidewire of the system to allow an operator to visualize characteristics of the cavity, as well as to control aspects of the system [¶’s [0088]-[0091]; FIG. 6]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Davies to include superimposing the position of the delivery component electrode and the crossing member electrode on a graphical representation of the heart in a display device, and wherein instructions to generate the alert include instructions to highlight a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart, since such a modification would provide the benefit/advantage of facilitating a procedure for a practitioner by enabling the practitioner to visualize the location, position, and/or orientation of the device components relative to one another, and to the heart, in real-time, thereby ensuring desired, safe, and effective device positioning. Conclusion 30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM. 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Bradford C. 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