DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 4, 5, 7, 10-12, 15, and 17-20 are cancelled. A complete action on the merits of pending claims 1-3, 6, 8, 9, 11-14, 16, and 21-25 appears herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/03/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/03/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Wittkampf (US 2011/0087261 A1).
Applicant’s arguments, see Remarks, filed 08/03/2026, with respect to the rejection(s) of claim(s) 16 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (US 6,152,918), in view of Wittkampf (US 2011/0087261 A1)
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8, 9, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Wittkampf (US 2011/0087261 A1).
Regarding claim 1, Gaiser teaches a device for transseptal access, (Fig. 1) comprising:
an ablation element (Fig. 1, Char. 18: tip; Col. 6, Lines 21-26) attached to a tubular member (Fig. 1, Char. 10: electrode catheter) configured to move within an elongated member, (Fig. 1, Char. 8: sheath; Col. 4, Lines 35-37), wherein the ablation element is configured to be advanced distally or proximally, (Col. 4, Lines 35-37) wherein the ablation element includes an electrode and incorporates radiofrequency energy to create a hole in a septum of the heart, (Col. 6, Lines 21-26; The ablative energy delivered by RF electrode (24) can be used to create a hole in any tissue if desired by a user, including the septum).
Gaiser further teaches a piercing element configured to pierce the septum of the heart, wherein the piercing element further incorporates a needle configured to mechanically pierce the septum; (Col. 3, Lines 8-15) wherein the electrode catheter (10) and distal tip (18) are passed through the punctured hole in the septal wall; (Col. 2, Lines 37-41)
Gaiser, as applied to claim 1 above, is silent regarding the ablation element comprising the piercing element; and wherein the piercing element further incorporates a measurement device located at a tip of the piercing element to measure a parameter associated with transseptal access, wherein the measurement device is configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved.
Saadat, in a similar field of endeavor, teaches a needle configured to deliver RF energy to ablate a target tissue. (Par. [0187])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gaiser, as applied to claim 1 above, to incorporate the teachings of Saadat, and configure the tip (18) of Gaiser to comprise a needle at the distal most end of said tip (18), such that said needle is configured to mechanically pierce the septum. Doing so would be a simple substitution of one septal hole creation mechanism for another for the predictable result of creating a hole in a septum through which the catheter (10) of Gaiser can be passed through, and would minimize the number of instruments needed to be introduced/removed from the treatment zone to perform the piercing and ablation steps/operations.
Gaiser, as applied to claim 1 above, is silent regarding the piercing element further incorporates a measurement device located at a tip of the piercing element to measure a parameter associated with transseptal access, wherein the measurement device is configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved.
Wittkampf, in a similar field of endeavor, teaches a transseptal puncturing device (Fig. 3-4) comprising a measurement device (Fig. 1B, Char. 43: pressure sensor) located at a tip of the piercing element (Fig. 1B, Char. 4: puncture section) to measure a parameter associated with transseptal access, (Par. [0056]: Pressure sensor (43) senses pressure) wherein the measurement device is configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved. (Par. [0042]: Multiple pressure measurements are taken, including during advancement into the septum, and the measured pressures provide a practitioner with feedback/confirmation that a puncture is made from the right atrium to the left atrium)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat, as applied to claim 1 above, to incorporate the teachings of Wittkampf, and include the pressure sensor (43) of Wittkampf in the tip of the piercing element of Gaiser, such that the pressure can be monitored/measured throughout the piercing of the septum, and a user can receive real time feedback based on said pressure measurements when transseptal access is achieved. Doing so would minimize the risk of only partially piercing through the septum, providing a safer procedure.
Regarding claim 2, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the parameter is pressure. (Wittkampf: Par. [0042] – it is implicit that this feature be present in the Gaiser/Saadat/Wittkampf combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the piercing element incorporates various shapes. (Gaiser: Fig. 3: the tip (18) of electrode catheter (10) is configured to be maneuvered into a state comprising a curved portion and a straight portion.)
Regarding claim 8, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches a dilator. (Gaiser: Col. 6, Lines 1-7: The dilator would still be used to dilate the opening created via the RF energy, ensuring the opening is wide enough to fit the sheath (8))
Regarding claim 9, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the elongate member is a sheath. (Gaiser: Fig. 1, Char. 8, Sheath)
Regarding claim 13, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the elongated member has further defined a guidewire lumen therein, the guidewire lumen extending from the proximal end to the distal end. (Gaiser: Col. 6, Lines 1-9: The guidewire would be positioned within sheath (8) as sheath 8 is navigated to the target area)
Regarding claim 14, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the distal end of the device incorporates a fixed curve. (Gaiser: Col. 4, Lines 5-9)
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Wittkampf (US 2011/0087261 A1), as applied to claim 1 above, and further in view of Wang (US 5,441,516).
Regarding Claim 6, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, is silent regarding polymer tubing surrounding the piercing element.
Wang, in a similar field of endeavor, teaches using a polymer tube as a protective sheath for surgical devices. (Fig. 11 and Col. 9, Lines 56-57)
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, to incorporate the teachings of Wang and have the sheath (8) of Gaiser be/include the polymeric materials taught by Wang since these materials are recognized by Wang as being suitable for the intended purpose of serving as a protective sheath for surgical instruments.
Claim(s) 16 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (US 6,152,918), in view of Wittkampf (US 2011/0087261 A1).
Regarding claim 16, Gaiser teaches a device for transseptal access, (Fig. 1) comprising:
an elongated member having a proximal end and a distal end, configured to be delivered to a septal location; (Fig. 1 and 3, Char. 8: sheath)
an ablation element (Fig. 1, Char. 18: tip; Col. 6, Lines 21-26) attached to a tubular member (Fig. 1, Char. 10: electrode catheter) that moves within the elongated member, (Fig. 1, Char. 8: sheath; Col. 4, Lines 35-37), wherein the ablation element is configured to be advanced distally or proximally, (Col. 4, Lines 35-37) wherein the ablation element includes an RF electrode and incorporates radiofrequency energy to create a hole in the septum, (Col. 6, Lines 21-26; The ablative energy delivered by RF electrode (24) can be used to create a hole in any tissue if desired by a user, including the septum).
Gaiser further teaches a piercing element configured to pierce the septum of the heart, wherein the piercing element further incorporates a needle configured to mechanically pierce the septum (Col. 3, Lines 8-15)
Gaiser, as applied to claim 16 above, is silent regarding the ablation element comprising the piercing element; and a governor to inhibit movement of the piercing element past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation; and a measurement device located at a tip of the piercing element to measure a parameter associated with transseptal access, the measurement device configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved.
Saadat, in a similar field of endeavor, teaches a needle configured to deliver RF energy to ablate a target tissue. (Par. [0187])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gaiser, as applied to claim 16 above, to incorporate the teachings of Saadat, and configure the tip (18) of Gaiser to comprise a needle at the distal most end of said tip (18), such that said needle is configured to mechanically pierce the septum. Doing so would be a simple substitution of one septal hole creation mechanism for another for the predictable result of creating a hole in a septum through which the catheter (10) of Gaiser can be passed through, and would minimize the number of instruments needed to be introduced/removed from the treatment zone to perform the piercing and ablation steps/operations.
The combination of Gaiser/Saadat, as applied to claim 16 above, is silent regarding a governor to inhibit movement of the piercing element past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation; and a measurement device located at a tip of the piercing element to measure a parameter associated with transseptal access, the measurement device configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved.
Padilla, in a similar field of endeavor, teaches actuating translation of an energy delivery device via a mechanical slide (Fig. 10A, Char. 106: finger slide) located at a handle of an instrument, the mechanical slide attached at least in part to the energy delivery device; (Col. 9, Line 63 – Col. 10, Line 13) and a governor coupled to the energy delivery device, and configured to inhibit movement of energy delivery device past a pre-specified point to avoid sudden exertion of the energy delivery device. (Col. 10, Lines 21-24)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Graiser/Saadat, as applied to claim 16 above, to incorporate the teachings of Padilla, and configure the handle (14) of Graiser to include a mechanical slide of Padilla configured to control translation of catheter (10) of Gaiser, and the depth stops (95) of Padilla, such that depth stops (95) inhibit movement of the distal tip (18) of Gaiser past a pre-specified point. Doing so would be a simple substitution of one translation control mechanism for another for the predictable result of translating catheter (10) within sheath (8) of Gaiser to a degree desired by a user.
In this combination, the depth stops (95) of Padilla would avoid sudden exertion of the needle through the septum and subsequent perforation by limiting the distance distal tip (18) of Gaiser can translate, at least in a situation where the next tissue structure past the septum is located at a distance past what the depth stops (95) would allow distal tip (18) to travel.
The combination of Gaiser/Saadat/Padilla, as applied to claim 16 above, is silent regarding a measurement device located at a tip of the piercing element to measure a parameter associated with transseptal access, the measurement device configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved.
Wittkampf, in a similar field of endeavor, teaches a transseptal puncturing device (Fig. 3-4) comprising a measurement device (Fig. 1B, Char. 43: pressure sensor) located at a tip of the piercing element (Fig. 1B, Char. 4: puncture section) to measure a parameter associated with transseptal access, (Par. [0056]: Pressure sensor (43) senses pressure) wherein the measurement device is configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved. (Par. [0042]: Multiple pressure measurements are taken, including during advancement into the septum, and the measured pressures provide a practitioner with feedback/confirmation that a puncture is made from the right atrium to the left atrium)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla, as applied to claim 16 above, to incorporate the teachings of Wittkampf, and include the pressure sensor (43) of Wittkampf in the tip of the piercing element of Gaiser, such that the pressure can be monitored/measured throughout the piercing of the septum, and a user can receive real time feedback based on said pressure measurements when transseptal access is achieved. Doing so would minimize the risk of only partially piercing through the septum, providing a safer procedure.
Regarding claim 23, the combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 16 above, teaches a guidewire. (Gaiser: Col. 6, Lines 1-7: Introduction into the right atrium can be accomplished with the aid of a conventional needle guidewire)
Regarding claim 24, the combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 16 above, teaches a sheath. (Gaiser: Fig. 6, Char. 42: outer sheath)
Regarding claim 25, the combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 24 above, teaches the sheath is steerable or incorporates a fixed curve. (Gaiser: Col. 5, Lines 63-67)
Claim(s) 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (US 6,152,918), in view of Wittkampf (US 2011/0087261 A1), as applied to claim 16 above, and further in view of Khairkhahan (US 2002/0169377 A1).
Regarding claim 21, the combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 16 above, teaches a dilator. (Gaiser: Col. 6, Lines 1-7)
The combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 16 above, is silent regarding the elongated member is the dilator.
Khairkhahan, in a similar field of endeavor, teaches a dilator (Fig. 1, Char. 20: dilator) comprising a tapered conical surface (Fig. 1-3, Char. 27: tapered surface and Par. [0060]) an inner sheath structure (Fig. 1, Char. 26: tubular body) configured to house a translating needle; (Par. [0048]: Needle (44) is axially moveable through aperture (45) in the distal end (24) of tubular body (26))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla/Wittkampf, as applied to claim 16 above, to incorporate the teachings of Khairkhahan, and configure sheath (8) of Gaiser to comprise the tapered conical surface (27) of Khairkhahan such that tapered surface (27) can dilate the transseptal hole created by the piercing element. Doing so would be a simple substitution of one dilator structure for another for the predictable result of dilating the transseptal hole.
Regarding claim 22, the combination of Gaiser/Saadat/Padilla/Wittkampf/Khairkhahan, as applied to claim 21 above, teaches the piercing element is embedded into the dilator. (Khairkhahan: Fig. 3 – it is implicit that this feature be present in the Gasier/Saadat/Padilla/Witkampf/Khairkhahan combination based on the rejection to claim 21 above.)
Conclusion
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
