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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/16/2026 and 2/17/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1, 10, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1 and 10 were rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and claim 20 was rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and McGee, the embodiment depicted in Figure 4A. Now, based on amendments to the claim language, claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and Krattiger and claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and McGee, the embodiment depicted in Figure 14.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6-7, 9-13, 15-16, and 18- 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al., US 20200315702, herein referred to as “Fang” in view of Davies et al., US 20190298411, herein referred to as “Davies”, further in view of Krattiger et al., US 20120277531, herein referred to as “Krattiger”.
Regarding claim 1, Fang discloses a puncturing device (Figure 1B) configured to create a puncture in a tissue ([0043]: “The system comprises a catheter 14, which is percutaneously inserted by an electrophysiologist or operator 16 through the patient's vascular system into a chamber or vascular structure of the heart 12.”) comprising: an elongate member (Figure 1B: elongated catheter body 141) comprising a proximal portion defining a longitudinal axis along the length of the elongate member (Figure 1B: portion of elongated catheter body 141 near control handle 146); a flexible distal portion of the elongate member that curves away from the longitudinal axis (Figure 1B: distal section 143); a distal tip configured to deliver energy to the tissue (Figure 1B: tip electrode 145 on distal tip end 143T and [0050]); and, a sensing element (Figure 2: sensor coils S1, S2, and S3) placed on the flexible distal portion of the elongate member (Figure 2) such that the sensing element detects curvature of the distal portion ([0054]: “Console 24 or the ablation power supply 25 may use, in one embodiment, magnetic sensing to determine pressure and position data, including (i) axial displacement and angular deflection of the distal section 143 due to pressure from contact with endocardial tissue 70, and (ii) position coordinates of the distal section 143 within the heart 12. In one embodiment, the catheter 14 includes a sensor assembly for generating contact force data, including axial displacement and angular deflection of the distal section 143 of the catheter 14.”); wherein when the flexible distal portion of the elongate member is straightened by an external constraint ([0061]: “ when contact is detected (based on, e.g., a detected contact force F.sub.N(t) on the catheter exceeds a zeroth threshold force F0 or temperature response to ablation), then the power at the catheter may be turned on at a first level P1.”), energy is delivered to the distal tip ([0058] and [0061]: “ when contact is detected (based on, e.g., a detected contact force F.sub.N(t) on the catheter exceeds a zeroth threshold force F0 or temperature response to ablation), then the power at the catheter may be turned on at a first level P1.”) and when the flexible distal portion of the elongate member is curved ([0061]: “If more force is applied to the catheter, thereby increasing the detected contact force, so that the force exceeds a first threshold force F1 (or a cutoff contact force Fmax), then the power delivered to the catheter is turned off ”), energy is not delivered to the distal tip ([0058] and [0061]: “If more force is applied to the catheter, thereby increasing the detected contact force, so that the force exceeds a first threshold force F1 (or a cutoff contact force Fmax), then the power delivered to the catheter is turned off ”). Fang does not explicitly disclose a puncturing device comprising an elongate member comprising a flexible distal portion of the elongate member that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis, or a puncturing device comprising a sensing element that detects a change of electrical resistance indicative of curvature of the distal portion.
However, Davies discloses a puncturing device (Figure 2A) comprising an elongate member comprising a flexible distal portion of the elongate member ([0135]: “deflectable region 200b of the steerable sheath 300”) that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis ([0077] and Figure 2A). In combination with Fang, when the when the flexible distal portion of the elongate member is curved in its predetermined curved shape, energy is not delivered to the distal tip.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the flexible distal portion of the elongate member has a predetermined curved shape when unconstrained that curves away from the longitudinal axis as taught by Davies to allow the device to be positioned at the desired location within a region of tissue (Davies [0077]).
Further, Krattiger teaches a device (Figure 7) comprising a sensing element (Figure 7: bend sensor 1) that detects a change of electrical resistance indicative of curvature of the distal portion (Figure 7: flexible portion 22 is the distal portion and [0054]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the sensing element detects a change of electrical resistance indicative of curvature of the distal portion as taught by Krattiger so that curvatures can be recorded in all directions correctly, simply, and securely (Krattiger [0054]).
Regarding claim 3, Fang in view of Davies and Krattiger discloses the puncturing device of claim 1, and Davies further discloses a puncturing device (Figure 5A) wherein the elongate member is composed of a conductive material (Figure 5F: wire 212 and [0091] and [0096]: “electrically conductive wire 212”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the elongate member is composed of a conductive material as taught by Davies so that the device is sufficiently flexible to bend about 180° and yet maintains sufficient rigidity to advance devices thereover (Davies [0084]).
Regarding claim 4, Fang in view of Davies and Krattiger discloses the puncturing device of claim 3, and Davies further discloses a puncturing device wherein the elongate member comprises a layer of insulation overtop of the conductive material (Figure 5F: electrical insulation 214 and [0096]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the elongate member comprises a layer of insulation overtop of the conductive material as taught by Davies to ensure that the distal section is substantially atraumatic (Davies [0103]).
Regarding claim 6, Fang in view of Davies and Krattiger discloses the puncturing device of claim 4, and Fang further discloses a puncturing device wherein the sensing element is positioned underneath the exterior of the elongate member (Figure 2: sensor coils S1, S2, and S3 are underneath the exterior of distal section 143). Davies discloses a puncturing device wherein the exterior of the elongate member is a layer of insulation (Figure 5F: electrical insulation 214 and [0096]). .
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the elongate member comprises a layer of insulation overtop of the conductive material as taught by Davies to ensure that the distal section is substantially atraumatic (Davies [0103]).
Regarding claim 7, Fang in view of Davies and Krattiger discloses the puncturing device of claim 1, and Fang further discloses a device wherein the sensing element is positioned on an inner portion of the flexible distal portion that undergoes compression when curved (Figure 2: sensor coils S1, S2, and S3 are on an inner portion of distal section 143).
Regarding claim 9, Fang in view of Davies and Krattiger discloses the puncturing device of claim 1, and Davies further teaches a device wherein the puncturing device is a J-tip guidewire or a pig-tail guidewire (Figure 5A: multi-function guidewire 200 and [0099]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that it is a pig-tail guidewire as taught by Davies to ensure that the device is sufficiently flexible to enable access to heart tissue (Davies [0083]).
Regarding claim 10, Fang discloses a puncturing assembly (Figure 1A) for puncturing a tissue ([0043]: “The system comprises a catheter 14, which is percutaneously inserted by an electrophysiologist or operator 16 through the patient's vascular system into a chamber or vascular structure of the heart 12.”), the puncturing assembly comprising: a puncturing device (Figure 1B) comprising an elongate member (Figure 1B: elongated catheter body 141) having a proximal portion defining a longitudinal axis along the length of the elongate member (Figure 1B: portion of elongated catheter body 141 near control handle 146); the puncturing device further comprising a flexible distal portion of the elongate member that curves away from the longitudinal axis (Figure 1B: distal section 143) and a sensing element (Figure 2: sensor coils S1, S2, and S3) placed on the flexible distal portion of the elongate member (Figure 2) such that the sensing element detects curvature of the flexible distal portion ([0054]: “Console 24 or the ablation power supply 25 may use, in one embodiment, magnetic sensing to determine pressure and position data, including (i) axial displacement and angular deflection of the distal section 143 due to pressure from contact with endocardial tissue 70, and (ii) position coordinates of the distal section 143 within the heart 12. In one embodiment, the catheter 14 includes a sensor assembly for generating contact force data, including axial displacement and angular deflection of the distal section 143 of the catheter 14.”); wherein the flexible distal portion ends in a distal tip configured to deliver energy to the tissue (Figure 1B: tip electrode 145 on distal tip end 143T and [0050]); and, a supporting member (Figure 1B: control handle 146) comprising a lumen configured to receive the puncturing device (Figure 1A); wherein the flexible distal portion is constrained to a straightened configuration when received within the lumen of the supporting member (Figure 1B: control handle 146 is rigid and therefore distal section 143 is constrained to a straightened configuration when within the lumen of control handle 146). Fang does not explicitly disclose a puncturing assembly comprising an elongate member comprising a flexible distal portion of the elongate member that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis, or a puncturing assembly comprising a sensing element that detects a change of electrical resistance indicative of curvature of the distal portion.
However, Davies discloses a puncturing assembly (Figure 2A) comprising an elongate member comprising a flexible distal portion of the elongate member ([0135]: “deflectable region 200b of the steerable sheath 300”) that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis ([0077] and Figure 2A). In combination with Fang, when the when the flexible distal portion of the elongate member is curved in its predetermined curved shape, energy is not delivered to the distal tip.
Further, Krattiger teaches an assembly (Figure 7) comprising a sensing element (Figure 7: bend sensor 1) that detects a change of electrical resistance indicative of curvature of the distal portion (Figure 7: flexible portion 22 is the distal portion and [0054]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the sensing element detects a change of electrical resistance indicative of curvature of the distal portion as taught by Krattiger so that curvatures can be recorded in all directions correctly, simply, and securely (Krattiger [0054]).
Regarding claim 11, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, and Fang further discloses an assembly wherein when the flexible distal portion is constrained within the supporting member ([0064]: “As seen in FIG. 5B, in one embodiment, output power may be initially applied at a highest value as soon as the catheter detects contact (e.g., a contact force F.sub.N(t) greater than a noise threshold) and decreases the power applied in steps as the contact force F.sub.N(t) increases.”), energy delivery is enabled (Figure 5B when force is 0) and when the flexible distal portion is unconstrained ([0064]: “As seen in FIG. 5B, in one embodiment, output power may be initially applied at a highest value as soon as the catheter detects contact (e.g., a contact force F.sub.N(t) greater than a noise threshold) and decreases the power applied in steps as the contact force F.sub.N(t) increases.”), energy delivery is disabled (Figure 5B when force Is high). Davies teaches an assembly wherein the flexible distal portion has an unconstrained, predetermined curve shape ([0077] and Figure 2A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the flexible distal portion of the elongate member has a predetermined curved shape when unconstrained as taught by Davies to allow the device to be positioned at the desired location within a region of tissue (Davies [0077]).
Regarding claim 12, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, and Fang further discloses an assembly wherein the supporting member comprises a dilator (Figure 1B: control handle 146).
Regarding claim 13, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, and Davies further teaches an assembly wherein the puncturing device is a J-tip guidewire or a pig-tail guidewire (Figure 5A: multi-function guidewire 200 and [0099]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that it is a pig-tail guidewire as taught by Davies to ensure that the device is sufficiently flexible to enable access to heart tissue (Davies [0083]).
Regarding claim 15, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, and Davies further discloses a puncturing assembly (Figure 5A) wherein the elongate member is composed of a conductive material (Figure 5F: wire 212 and [0091] and [0096]: “electrically conductive wire 212”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the elongate member is composed of a conductive material as taught by Davies so that the device is sufficiently flexible to bend about 180° and yet maintains sufficient rigidity to advance devices thereover (Davies [0084]).
Regarding claim 16, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 15, and Davies further discloses a puncturing assembly wherein the elongate member comprises a layer of insulation overtop of the conductive material (Figure 5F: electrical insulation 214 and [0096]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the elongate member comprises a layer of insulation overtop of the conductive material as taught by Davies to ensure that the distal section is substantially atraumatic (Davies [0103]).
Regarding claim 18, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 16, and Fang further discloses a puncturing assembly wherein the sensing element is positioned underneath the exterior of the elongate member (Figure 2: sensor coils S1, S2, and S3 are underneath the exterior of distal section 143). Davies discloses a puncturing assembly wherein the exterior of the elongate member is a layer of insulation (Figure 5F: electrical insulation 214 and [0096]). .
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the elongate member comprises a layer of insulation overtop of the conductive material as taught by Davies to ensure that the distal section is substantially atraumatic (Davies [0103]).
Regarding claim 19, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, and Fang further discloses an assembly wherein the sensing element is positioned on an inner portion of the flexible distal portion that undergoes compression when curved (Figure 2: sensor coils S1, S2, and S3 are on an inner portion of distal section 143) or on an outer portion of the flexible distal portion that undergoes tension when curved.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and Krattiger, further in view of Leo et al., US 20140194869, herein referred to as “Leo”.
Regarding claim 2, Fang in view of Davies and Krattiger discloses the puncturing device of claim 1, but does not explicitly disclose a puncturing device wherein the sensing element is a strain gauge.
However, Leo teaches a puncturing device (Figure 1) wherein the sensing element is a strain gauge ([0027]: “ In one embodiment, the force sensor includes a fiber optic strain gauge. ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the sensing element is a strain gauge as taught by Leo to determine a size parameter based on the force-time integral determined by the strain gauge (Leo [0032]).
Regarding claim 14, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 10, but does not explicitly disclose a puncturing assembly wherein the sensing element is a strain gauge.
However, Leo teaches a puncturing assembly (Figure 1) wherein the sensing element is a strain gauge ([0027]: “ In one embodiment, the force sensor includes a fiber optic strain gauge. ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the sensing element is a strain gauge as taught by Leo to determine a size parameter based on the force-time integral determined by the strain gauge (Leo [0032]).
Claims 5, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies and Krattiger, further in view of Brannan et al., US 20130267946, herein referred to as “Brannan”.
Regarding claim 5, Fang in view of Davies and Krattiger discloses the puncturing device of claim 4, and Davies further discloses a puncturing device wherein there is a layer of insulation (Figure 5F: electrical insulation 214 and [0096]). Fang in view of Davies does not explicitly disclose a puncturing device wherein the sensing element is positioned overtop the layer of insulation.
However, Brannan discloses a puncturing device (Figure 1) wherein the sensing element is positioned overtop the elongate member (Figure 6: electrical contacts 410 and 412). In combination with Fang and Davies, the electrical contacts of Brannan would be on the exterior of the elongate member as they are in Brannan, and therefore they would be overtop the layer of insulation of Davies.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the sensing element is positioned overtop the elongate member as taught by Brannan to ensure that there is an audible alarm when the device is between a predetermined amount (Brannan [0056]).
Regarding claim 8, Fang in view of Davies and Krattiger discloses the puncturing device of claim 1, with Fang disclosing a flexible distal portion that undergoes tension when curved (Figure 1B: distal section 143), but does not explicitly disclose a puncturing device wherein the sensing element is positioned on an outer portion of the flexible distal portion that undergoes tension when curved.
However, Brannan discloses a puncturing device (Figure 1) wherein the sensing element is positioned overtop the elongate member (Figure 6: electrical contacts 410 and 412). In combination with Fang, the electrical contacts of Brannan would be positioned on the outside of distal section 143 of Fang, and thus, the sensing element is positioned on an outer portion of the flexible distal portion that undergoes tension when curved.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the sensing element is positioned overtop the elongate member as taught by Brannan to ensure that there is an audible alarm when the device is between a predetermined amount (Brannan [0056]).
Regarding claim 17, Fang in view of Davies and Krattiger discloses the puncturing assembly of claim 16, and Davies further discloses a puncturing assembly wherein there is a layer of insulation (Figure 5F: electrical insulation 214 and [0096]). Fang in view of Davies does not explicitly disclose a puncturing assembly wherein the sensing element is positioned overtop the layer of insulation.
However, Brannan discloses a puncturing assembly (Figure 1) wherein the sensing element is positioned overtop the elongate member (Figure 6: electrical contacts 410 and 412). In combination with Fang and Davies, the electrical contacts of Brannan would be on the exterior of the elongate member as they are in Brannan, and therefore they would be overtop the layer of insulation of Davies.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing assembly disclosed by Fang so that the sensing element is positioned overtop the elongate member as taught by Brannan to ensure that there is an audible alarm when the device is between a predetermined amount (Brannan [0056]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davies, further in view of McGee et al., US 7976541, herein referred to as “McGee”.
Regarding claim 20, Fang discloses a puncturing device (Figure 1B) for puncturing a target tissue ([0043]: “The system comprises a catheter 14, which is percutaneously inserted by an electrophysiologist or operator 16 through the patient's vascular system into a chamber or vascular structure of the heart 12.”), the puncturing device comprising: an elongate member (Figure 1B: elongated catheter body 141) comprising a proximal portion defining a longitudinal axis along the length of the elongate member (Figure 1B: portion of elongated catheter body 141 near control handle 146); a flexible distal portion of the elongate member that curves away from the longitudinal axis (Figure 1B: distal section 143); a distal tip configured to deliver energy to the tissue (Figure 1B: tip electrode 145 on distal tip end 143T and [0050]); a first conductive wire extending along the proximal portion of the elongate member (Figure 2: 63), wherein the first conductive wire ends at a distance along the flexible distal portion (Figure 2: 63 ends at 60); a second conductive wire coupled to the distal tip (Figure 2: 62 is coupled to field generator MF), wherein the second conductive wire ends distal to the first conductive wire (Figure 2: 62 ends distal to 64A); wherein the first and second conductive wire are positioned along an outer edge of the flexible distal portion (Figure 2: 63 and 62 are positioned along an outer edge of distal section 143). Fang does not explicitly disclose a puncturing device comprising an elongate member comprising a flexible distal portion of the elongate member that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis; or a puncturing device whereby, when the flexible distal portion is straightened by an external constraint, the first conductive wire contacts the second conductive wire due to the first conductive wire and the second conductive wire being compressed together upon straightening of the flexible distal portion, thereby enabling energy delivery from the first conductive wire to the distal tip via the second conductive wire; and, whereby, when the flexible distal portion is curved in its predetermined curved shape, the first conductive wire does not contact the second conductive wire due to the first conductive wire and the second conductive wire being pulled apart upon the curved distal portion returning to the predetermined curved shape, thereby disabling energy delivery from the first conductive wire to the distal tip.
However, Davies discloses a puncturing device (Figure 2A) comprising an elongate member comprising a flexible distal portion of the elongate member ([0135]: “deflectable region 200b of the steerable sheath 300”) that has a predetermined curved shape when unconstrained that curves away from the longitudinal axis ([0077] and Figure 2A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that the flexible distal portion of the elongate member has a predetermined curved shape when unconstrained that curves away from the longitudinal axis as taught by Davies to allow the device to be positioned at the desired location within a region of tissue (Davies [0077]).
Further, McGee teaches a puncturing device (Figure 1) whereby, when the flexible distal portion is straightened by an external constraint, the first conductive wire (Figure 14: power wire 124) contacts the second conductive wire (Figure 14: return wire 127) due to the first conductive wire and the second conductive wire being compressed together upon straightening of the flexible distal portion (Figure 16: return wire 127 and power wire 124 are connected via CP1), thereby enabling energy delivery from the first conductive wire to the distal tip via the second conductive wire (Col. 8, line 54 – Col. 9, line 21); and, whereby, when the flexible distal portion is curved in its predetermined curved shape, the first conductive wire does not contact the second conductive wire due to the first conductive wire and the second conductive wire being pulled apart upon the curved distal portion returning to the predetermined curved shape (Figure 14: return wire 127 and power wire 124 are not connected via CP1), thereby disabling energy delivery from the first conductive wire to the distal tip (Col. 8, line 54 – Col. 9, line 21).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the puncturing device disclosed by Fang so that when the flexible distal portion is straightened, the first conductive wire contacts the second conductive wire, thereby enabling energy delivery; and, whereby, when the flexible distal portion is curved, the first conductive wire does not contact the second conductive wire, thereby disabling energy delivery as taught by McGee so that the device is only activated when a suitable level of tissue contact has been achieved (McGee Col. 9, lines 16-21).
Conclusion
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794