DETAILED ACTION
NOTICE OF PRE-AIA OR AIA STATUS
1. 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
2. Applicant’s Amendment filed July 8, 2026 (“07/08/26 Amendment") has been entered, and fully considered.
3. In the 07/08/26 Amendment:
claims 1-3, 5-11, & 17, & 20 were amended;
no claims were cancelled; &
no claims were newly added.
4. Therefore, claims 1-20 remain pending in the application.
5. The 07/08/26 Amendment has overcome the claim rejections under §§ 112(b), 102, & 103 previously set forth in the Non-Final Office Action mailed 04/08/26 (“04/08/26 Action”).
6. A new claim objection and new grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
CLAIM OBJECTIONS
7. Claim 20 is objected to because of the following informalities:
In claim 20, lines 1-2, the recitation of “wherein generating the alert includes highlight a graphical illustration” should instead recite --wherein generating the alert includes highlighting a graphical illustration--.
Appropriate correction is required.
CLAIM REJECTIONS - 35 USC § 103
8. 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.
9. 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.
10. Claims 1-3, 6, & 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2022/0257313 to Davies et al. (“Davies”) in view of U.S. 2023/0390529 to Schwartz et al. ("Schwartz").
11. Regarding claim 1, Davies teaches 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]],
***
generate an alert... if the crossing member electrode [(113)] is extended from the [dilating tip] 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”); NOTE: as broadly as claimed, the protrusion spacing (in this case, any spacing greater than zero) is “specified” when the system is initially “configured” to provide the protrusion alert - ¶[0077]].
DISTANCE
Davies teaches that the EAM system is used to determine:
the location of the dilating tip of the dilator [e.g., ¶[0073]];
the positioning of the perforation device [e.g., ¶[0076]];
the location of the perforating electrode with respect to the dilating tip [e.g., ¶[0076]]; and
the relative positioning between the perforation electrode and the EAM electrode on the dilating tip [e.g., ¶[0076]].
As noted above, Davies is also concerned with generating an alert based on the position of the perforating electrode with respect to the dilating tip.
Davies does not, however, explicitly teach that the EAM system determines a distance between the perforating electrode (113) [crossing member electrode] and the EAM electrode (148) [delivery component electrode]. As such, Davies does not explicitly teach the following emphasized claim limitations:
determine a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)], and
generate an alert based on the determined distance if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing.
Schwartz, in a similar field of endeavor, relates to the field of medical catheters and methods for their use in tissue puncturing procedures, including cardiac tissue puncturing procedures [e.g., ¶[0001]], and is concerned with improving the determination of information associated with a transseptal puncturing (TP) procedure without the use of X-ray or ultrasound-based technologies [¶’s [0003], [0005]].
More particularly, Schwartz teaches a catheter system comprising a sheath lumen, a dilator slidably housed within the sheath lumen, and a needle slidably contained within the dilator lumen [¶’s [0087]-[0088]], and teaches that all three may include electrodes [e.g., ¶[0100]].
Schwartz teaches that any of the electrodes, whether having fixed interelectrode distances or not, may be used to determine a location and/or orientation of parts of the puncturing system with respect to an anatomy or part thereof [see ¶[0115]], and further teaches that the system can include an electro-anatomical mapping system [see ¶[0116] (“To use the electrical signals provided by the electrodes of a catheter systems as described herein, a processing system is configured to receive them and the parameters of the catheter system or the surrounding tissue... The medical system can comprise a dielectric imaging system or electro-anatomical mapping system such as for example a Carto™, Kodex™, EnSite™, Rythmia™ or other similar system that is capable of creating an electric field in a region of a subject which electric field may evoke electrical responses in the electrodes of the catheter systems disclosed herein when inserted in the region of interest”)].
Scwartz additionally teaches using the difference in the electrical responses of the electrodes to determine a distance between the electrodes [see ¶[0170] (“the difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle and/or a distance that the needle extends out of the sheath”)].
Given that Davies and Schwartz are each concerned with determining the location/position and/or orientation of components of the puncturing system, that each teach the use of similar EAM systems [both teach that the Ensite™ and Carto® systems may be used – see Davies at ¶[0064], and Schwartz at ¶[0116]], and that each is concerned with the distance that the needle extends out of the sheath during a TP procedure, 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 implement a known, art-recognized technique when establishing the alert criteria (of Davies) concerning extension of the perforating electrode past the dilating tip, including one wherein a difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle, or, more particularly, to determine a distance between the crossing member electrode (113) and the delivery component electrode (148), and generate the alert of Davies based on the determined distance, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Schwartz), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Davies, and the result [establishing the alert criteria of Davies concerning extension of the perforating electrode past the dilating tip based on a determined distance between the electrodes mounted thereon] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
12. Regarding claim 2, the combination of Davies and Schwartz teaches 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 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].
13. Regarding claim 3, the combination of Davies and Schwartz teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Davies further teaches an RF generator [RF generator (114) - ¶[0049]; FIG. 1] to provide the RF energy source.
14. Regarding claim 6, the combination of Davies and Schwartz teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Davies further teaches 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].
15. Regarding claim 8, the combination of Davies and Schwartz teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Davies further teaches 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]].
16. Regarding claim 9, the combination of Davies and Schwartz teaches 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”)].
The combination of Davies and Schwartz does not, however, explicitly teach 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 the combination of Davies and Schwartz 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.
17. Regarding claim 10, the combination of Davies and Schwartz 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]; FIGS. 2, 7].
18. Regarding claim 11, Davies teaches 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]],
***
generate an alert... if the crossing member electrode [(113)] is extended from the [dilating tip] 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”); NOTE: as broadly as claimed, the protrusion spacing (in this case, any spacing greater than zero) is “specified” when the system is initially “configured” to provide the protrusion alert - ¶[0077]].
DISTANCE
Davies teaches that the EAM system is used to determine:
the location of the dilating tip of the dilator [e.g., ¶[0073]];
the positioning of the perforation device [e.g., ¶[0076]];
the location of the perforating electrode with respect to the dilating tip [e.g., ¶[0076]]; and
the relative positioning between the perforation electrode and the EAM electrode on the dilating tip [e.g., ¶[0076]].
As noted above, Davies is also concerned with generating an alert based on the position of the perforating electrode with respect to the dilating tip.
Davies does not, however, explicitly teach that the EAM system determines a distance between the perforating electrode (113) [crossing member electrode] and the EAM electrode (148) [delivery component electrode]. As such, Davies does not explicitly teach the following emphasized claim limitations:
determine a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)], and
generate an alert based on the determined distance if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing.
Schwartz, in a similar field of endeavor, relates to the field of medical catheters and methods for their use in tissue puncturing procedures, including cardiac tissue puncturing procedures [e.g., ¶[0001]], and is concerned with improving the determination of information associated with a transseptal puncturing (TP) procedure without the use of X-ray or ultrasound-based technologies [¶’s [0003], [0005]].
More particularly, Schwartz teaches a catheter system comprising a sheath lumen, a dilator slidably housed within the sheath lumen, and a needle slidably contained within the dilator lumen [¶’s [0087]-[0088]], and teaches that all three may include electrodes [e.g., ¶[0100]].
Schwartz teaches that any of the electrodes, whether having fixed interelectrode distances or not, may be used to determine a location and/or orientation of parts of the puncturing system with respect to an anatomy or part thereof [see ¶[0115]], and further teaches that the system can include an electro-anatomical mapping system [see ¶[0116] (“To use the electrical signals provided by the electrodes of a catheter systems as described herein, a processing system is configured to receive them and the parameters of the catheter system or the surrounding tissue... The medical system can comprise a dielectric imaging system or electro-anatomical mapping system such as for example a Carto™, Kodex™, EnSite™, Rythmia™ or other similar system that is capable of creating an electric field in a region of a subject which electric field may evoke electrical responses in the electrodes of the catheter systems disclosed herein when inserted in the region of interest”)].
Scwartz additionally teaches using the difference in the electrical responses of the electrodes to determine a distance between the electrodes [see ¶[0170] (“the difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle and/or a distance that the needle extends out of the sheath”)].
Given that Davies and Schwartz are each concerned with determining the location/position and/or orientation of components of the puncturing system, that each teach the use of similar EAM systems [both teach that the Ensite™ and Carto® systems may be used – see Davies at ¶[0064], and Schwartz at ¶[0116]], and that each is concerned with the distance that the needle extends out of the sheath during a TP procedure, 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 implement a known, art-recognized technique when establishing the alert criteria (of Davies) concerning extension of the perforating electrode past the dilating tip, including one wherein a difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle, or, more particularly, to determine a distance between the crossing member electrode (113) and the delivery component electrode (148), and generate the alert of Davies based on the determined distance, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Schwartz), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Davies, and the result [establishing the alert criteria of Davies concerning extension of the perforating electrode past the dilating tip based on a determined distance between the electrodes mounted thereon] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
19. Regarding claim 12, the combination of Davies and Schwartz teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Davies further teaches wherein the set of instructions further includes instructions to receive the specified protrusion spacing from a user input [NOTE: it is the Examiner’s position that this limitation is implicitly satisfied when the system is initially “configured” to provide the protrusion alert - ¶[0077]].
20. Regarding claim 13, the combination of Davies and Schwartz teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Davies does not explicitly teach:
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 the combination of Davies and Schwartz 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.
21. Regarding claims 14 & 15, the combination of Davies and Schwartz teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Davies/Schwartz further teaches: [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; & [claim 15] wherein instructions to generate the alert include instructions to highlight [feature] a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart [see Schwartz, e.g., ¶’s [0050], [0125], [0126], [0143], [0154], [0163] (“The processing system may therefore be further configured to display, at a user interface, a visual representation of the relative location of the (electrodes of the) puncturing device. This can be displayed with respect to a visual representation of the anatomical model, e.g. obtained at the user interface”); [0173], [0174], [0176], [0178], [0202]-[0206]; & FIGS. 7-8]. Schwartz teaches that, by providing a visual representation of the anatomy and the puncturing device, the clinician is aided in the performance of a surgical procedure by their tracking and monitoring of the relative location of the puncturing device [e.g., ¶[0206]].
22. Regarding claim 16, the combination of Davies and Schwartz teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
The combination of Davies and Schwartz does not, however, teach:
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 the combination of Davies and Schwartz 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 17, 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;
***
generating an alert... with the electroanatomical mapping system [(104)] if the crossing member electrode is extended from the [dilating tip] 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”); NOTE: as broadly as claimed, the protrusion spacing (in this case, any spacing greater than zero) is “specified” when the system is initially “configured” to provide the protrusion alert - ¶[0077]].
DISTANCE
Davies teaches that the EAM system is used to determine:
the location of the dilating tip of the dilator [e.g., ¶[0073]];
the positioning of the perforation device [e.g., ¶[0076]];
the location of the perforating electrode with respect to the dilating tip [e.g., ¶[0076]]; and
the relative positioning between the perforation electrode and the EAM electrode on the dilating tip [e.g., ¶[0076]].
As noted above, Davies is also concerned with generating an alert based on the position of the perforating electrode with respect to the dilating tip.
Davies does not, however, explicitly teach that the EAM system determines a distance between the perforating electrode (113) [crossing member electrode] and the EAM electrode (148) [delivery component electrode]. As such, Davies does not explicitly teach the following emphasized claim limitations:
determining a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)] with the electroanatomical mapping system; and
generating an alert based on the determined distance with the electroanatomical mapping system if the crossing member electrode is extended from the delivery component electrode at a specified protrusion spacing.
Schwartz, in a similar field of endeavor, relates to the field of medical catheters and methods for their use in tissue puncturing procedures, including cardiac tissue puncturing procedures [e.g., ¶[0001]], and is concerned with improving the determination of information associated with a transseptal puncturing (TP) procedure without the use of X-ray or ultrasound-based technologies [¶’s [0003], [0005]].
More particularly, Schwartz teaches a catheter system comprising a sheath lumen, a dilator slidably housed within the sheath lumen, and a needle slidably contained within the dilator lumen [¶’s [0087]-[0088]], and teaches that all three may include electrodes [e.g., ¶[0100]].
Schwartz teaches that any of the electrodes, whether having fixed interelectrode distances or not, may be used to determine a location and/or orientation of parts of the puncturing system with respect to an anatomy or part thereof [see ¶[0115]], and further teaches that the system can include an electro-anatomical mapping system [see ¶[0116] (“To use the electrical signals provided by the electrodes of a catheter systems as described herein, a processing system is configured to receive them and the parameters of the catheter system or the surrounding tissue... The medical system can comprise a dielectric imaging system or electro-anatomical mapping system such as for example a Carto™, Kodex™, EnSite™, Rythmia™ or other similar system that is capable of creating an electric field in a region of a subject which electric field may evoke electrical responses in the electrodes of the catheter systems disclosed herein when inserted in the region of interest”)].
Scwartz additionally teaches using the difference in the electrical responses of the electrodes to determine a distance between the electrodes [see ¶[0170] (“the difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle and/or a distance that the needle extends out of the sheath”)].
Given that Davies and Schwartz are each concerned with determining the location/position and/or orientation of components of the puncturing system, that each teach the use of similar EAM systems [both teach that the Ensite™ and Carto® systems may be used – see Davies at ¶[0064], and Schwartz at ¶[0116]], and that each is concerned with the distance that the needle extends out of the sheath during a TP procedure, 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 implement a known, art-recognized technique when establishing the alert criteria (of Davies) concerning extension of the perforating electrode past the dilating tip, including one wherein a difference in the electrical responses of the electrode(s) mounted on the sheath and the distal end of the needle may be directly correlated to a distance between the electrode(s) and the distal end of the needle, or, more particularly, to include determining a distance between the crossing member electrode [(113)] and the delivery component electrode [(148)] with the electroanatomical mapping system, and generating the alert of Davies based on the determined distance, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Schwartz), and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Davies, and the result [establishing the alert criteria of Davies concerning extension of the perforating electrode past the dilating tip based on a determined distance between the electrodes mounted thereon] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
24. Regarding claim 18, the combination of Davies and Schwartz teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Davies further teaches receiving the specified protrusion spacing from a user input [NOTE: 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 teach:
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 the combination of Davies and Schwartz 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.
25. Regarding claims 19 & 20, the combination of Davies and Schwartz teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action
Davies/Schwartz further teaches: [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 generating the alert includes highlight [feature] a graphical illustration of the crossing member electrode extended from the delivery component electrode superimposed on the graphical representation of the heart [see Schwartz, e.g., ¶’s [0050], [0125], [0126], [0143], [0154], [0163] (“The processing system may therefore be further configured to display, at a user interface, a visual representation of the relative location of the (electrodes of the) puncturing device. This can be displayed with respect to a visual representation of the anatomical model, e.g. obtained at the user interface”); [0173], [0174], [0176], [0178], [0202]-[0206]; & FIGS. 7-8]. Schwartz teaches that, by providing a visual representation of the anatomy and the puncturing device, the clinician is aided in the performance of a surgical procedure by their tracking and monitoring of the relative location of the puncturing device [e.g., ¶[0206]].
26. Claims 4, 5, & 7 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Davies & Schwartz, and further in view of WO 2021/255556 to MacDonald et al. ("MacDonald”).
27. Regarding claims 4 & 5, the combination of Davies and Schwartz teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
The combination of Davies and Schwartz does not, however, teach:
[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 further modify the combination of Davies & Schwartz 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).
28. Regarding claim 7, the combination of Davies and Schwartz teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Davies and Schwartz does not, however, teach:
wherein the crossing member 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 further modify the combination of Davies & Schwartz 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).
RESPONSE TO ARGUMENTS
29. As noted above, the 07/08/26 Amendment has overcome the claim rejections under §§ 112(b), 102, & 103 previously set forth in the 04/08/26 Action.
30. A new claim is set forth herein, necessitated by Applicant’s Amendment.
31. Applicant's arguments concerning the prior rejections under §§ 102 & 103 have been fully considered and are persuasive (in view of the current Amendment). Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection under § 103 are set forth in detail above, necessitated by Applicant’s Amendment.
CONCLUSION
32. 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 extension fee 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 date of this final action.
33. 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, 8:30 AM - 4:30 PM MST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 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 an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing 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. BLAISE/Primary Examiner, Art Unit 3794
