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 .
Response to Amendment
The amendment submitted August 11th, 2025 has been entered. Applicant’s amendments to the claims have overcome the claim objection previously set forth in the Non-Final Office Action mailed May 9th, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 & 3 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the second layer” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-16 are also rejected by virtue of their dependency on claim 3.
Claim 9 recites the limitation “the circuit disk” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the electrical signals” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the electrical signals” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “the second layer” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-22 are also rejected by virtue of their dependency on claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3-6, 8-14,16-22 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Bar-Tal et al. (U.S. Pub. No. 20180071017, cited in IDS), herein referred to as “Bar-Tal”.
Regarding claim 3, Bar-Tal teaches a surgical instrument (Abstract: Described embodiments include apparatus that includes a catheter and a tip electrode) comprising:
a handle (catheter handle 84);
a catheter body (catheter 22) extending distally from the handle (see Fig. 1), a proximal portion of the catheter body defining a longitudinal axis (see axis of catheter extending from handle 84 to the distal end in Fig. 1); and
an end effector extending distally from the catheter body ([0100]: Catheter 22 comprises a catheter shaft 82, at a distal end of which is disposed a tip electrode 24),
at least one of an electrode (microelectrode 40) or a thermocouple on the end effector (see microelectrodes 40 on tip electrode 24 in Fig. 1), the at least one of the electrode or the thermocouple comprising a first three-dimensional structure (see dome shape of microelectrode 40 on tip electrode 24 in Fig. 2) comprising:
a first non-conductive layer (isolating wall 64) in contact with the end effector ([0110]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66), the second layer comprising a non-conductive material ([0100]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66, thus electrically- and thermally-isolating the conducting element from the tip electrode), and
a first electrically conductive layer (a conducting element 66) in contact with the first non-conductive layer ([0100]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66), the first electrically conductive layer comprising a first electrically conductive material (conducting element 66), and
at least one of a force sensor (strain gauge 48; [0104]: strain gauge 48 being configured to measure the strain in the bridge to which the strain gauge is coupled. As described above, these measurements may be used to estimate the force applied to the tissue by the catheter during the ablation procedure) or a position sensor on the catheter body ([0104]: Typically, catheter 22 further comprises a slotted tube 46, … tube 46 is shaped to define one or more slots 70 … each of slots 70 separating between two respective segments of the tube … Each pair of neighboring segments is spanned by a bridge 74. One or more strain gauges 48 are coupled to bridges 74), the at least one of the force sensor or the position sensor comprising a second three-dimensional structure (see 3D structure of strain gauge 48 in Fig. 3), comprising:
a super elastic layer (slotted tube 46) in contact with a surface of the catheter body ([0104]: a slotted tube 46, which is typically situated at a distal portion of the catheter, such as immediately proximally to, and/or partly underneath, tip electrode 24; wherein the tip electrode 24 is an outer surface of the catheter body), the super elastic layer comprising a super elastic material ([0104]: Typically, slotted tube 46 is metallic; for example, the slotted tube may be manufactured from any suitable metallic alloy, such as nitinol),
a second non-conductive layer in contact with a surface of the super elastic layer, the second non-conductive layer comprising a non-conductive material ([0119]: For example, each strain gauge shown in FIG. 3 comprises a resistor 76. As the shape of the strain gauge changes due to the strain in the bridge, the resistance of resistor 76 changes. Via PCB 58, a voltage may be applied across the strain gauge, such that the measured current flowing through the strain gauge indicates the change in resistance of the strain gauge, and hence, the strain in the bridge; wherein it is known that strain gauges comprise a resistor on an insulative/dielectric substrate such that the stretching/compression of the sensor causes increases/decreases in resistance of the resistor and therefore while not explicitly described, the strain gauge 48 comprises a resistor 76 on an insulative substrate & the strain gauge (including the insulative substrate) is on slotted tube 46, see Fig. 3), and
a second electrically conductive layer in contact with the second non-conductive layer, the second electrically conductive layer comprising a second electrically conductive material ([0119]: For example, each strain gauge shown in FIG. 3 comprises a resistor 76. As the shape of the strain gauge changes due to the strain in the bridge, the resistance of resistor 76 changes. Via PCB 58, a voltage may be applied across the strain gauge, such that the measured current flowing through the strain gauge indicates the change in resistance of the strain gauge, and hence, the strain in the bridge. Alternatively, a current may be applied across the strain gauge, such that the measured voltage across the strain gauge indicates the change in resistance of the strain gauge. This measured voltage or current is referred to herein as the “signal,” output by the strain gauge, that indicates the strain in the bridge; wherein the resistor 76 comprises a conductive material since the current across it is measured).
Regarding claim 4, Bar-Tal teaches wherein the first non-conductive layer (isolating wall 64) of the first three-dimensional structure is in contact with an inner surface of the end effector or an outer surface of the end effector ([0110]: each microelectrode is cylindrically shaped, whereby isolating wall has an annular shape, and the outer surface of conducting element 66, which forms the top of the cylinder, is circular. Typically, the diameter of the microelectrode apertures in the tip electrode is only slightly larger than that of the microelectrodes, such that the microelectrodes fit snugly into the apertures. Alternatively or additionally, during the manufacture of catheter 22, the microelectrodes may be glued to, or otherwise fixed to, the respective perimeters of the microelectrode apertures. Thus, the microelectrodes are securely coupled to the tip electrode; wherein the isolating wall 64 is in contact with an inner surface of the tip electrode 24 and the outer surface of the tip electrode 24).
Regarding claim 5, Bar-Tal teaches wherein the super elastic layer (slotted tube 46) of the second three-dimensional structure is in contact with an outer surface of the catheter body or an inner surface of the catheter body (see Fig. 4 where the slotted tube 46 is within the distal end of the catheter 22 such that it is in contact with an inner surface of the catheter body).
Regarding claim 6, Bar-Tal teaches wherein the at least one electrode comprises a sensing electrode ([0110]: Conducting element 66 is typically electrically coupled to PCB 58 (e.g., by being directly connected to the PCB), such that ECG signals detected by the conducting surface may be carried by the PCB from the distal end of the catheter), a reference electrode, or an ablating electrode.
Regarding claim 8, Bar-Tail teaches a circuit disk (distal end of PCB 58, rounded disk shape around distal opening 57) axially aligned with the longitudinal axis (see Fig. 2), the circuit disk configured to communicate electrical signals with the at least one electrode ([0109]: microelectrodes 40 are coupled to the PCB, and the PCB carries signals from the microelectrodes to the proximal end of the catheter. In some embodiments, PCB 58 also carries signals to the distal end of the catheter).
Regarding claim 9, Bar-Tal teaches a tab (portion of PCB 58 that extends along the circumference/sides of distal portion in Fig. 2) extending from the at least one electrode, the circuit disk comprising circuitry configured to communicate electrically with the at least one electrode via the tab ([0109]: the PCB carries signals from the microelectrodes to the proximal end of the catheter. In some embodiments, PCB 58 also carries signals to the distal end of the catheter).
Regarding claim 10, Bar-Tal teaches wherein the electrical signals include radiofrequency (RF) energy ([0109]: Alternatively or additionally, PCB 58 may carry signals, such as current signals for injection for impedance measurements, to the microelectrodes, and/or ablating signals to the tip electrode via an electrical coupling between tube 46 and tip electrode).
Regarding claim 11, Bar-Tal teaches wherein the electrical signals include electrophysiology (EP) mapping signals ([0110]: Conducting element 66 is typically electrically coupled to PCB 58 (e.g., by being directly connected to the PCB), such that ECG signals detected by the conducting surface may be carried by the PCB from the distal end of the catheter).
Regarding claim 12, Bar-Tal teaches wherein the super elastic material of the super elastic layer of the second three-dimensional structure comprises nitinol ([0104]: Typically, slotted tube 46 is metallic; for example, the slotted tube may be manufactured from any suitable metallic alloy, such as nitinol).
Regarding claim 13, Bar-Tal teaches wherein the super elastic layer of the second three-dimensional structure comprises a thin film of the super elastic material ([0132]: tube 46 are formed from a single piece of material, e.g., a single piece of nitinol; wherein absent a claimed thickness, this is seen as a thin film of nitinol).
Regarding claim 14, Bar-Tal teaches wherein the thin film of the super elastic material comprises a strip of the super elastic material ([0116]: slotted tube 46 is shaped to define one or more slots 70, at respective longitudinal positions along the tube, which divide the tube into a plurality of segments. For example, in FIG. 3, three slots divide the tube into four segments—a first segment 72a, a second segment 72b, a third segment 72c, and a fourth segment 72d; wherein each segment is seen as a strip).
Regarding claim 16, Bar-Tal teaches wherein the end effector comprises one or more irrigation openings ([0103]: tip electrode 24 is further shaped to define a plurality of fluid apertures 50).
Regarding claim 17, Bar-Tal teaches a surgical instrument (Abstract: Described embodiments include apparatus that includes a catheter and a tip electrode) comprising:
a handle (catheter handle 84);
a catheter body (catheter 22) extending distally from the handle (see Fig. 1), a proximal portion of the catheter body defining a longitudinal axis (see axis of catheter extending from handle 84 to the distal end in Fig. 1); and
an end effector extending distally from the catheter body ([0100]: Catheter 22 comprises a catheter shaft 82, at a distal end of which is disposed a tip electrode 24),
at least one of an electrode (microelectrode 40) or a thermocouple on the end effector (see microelectrodes 40 on tip electrode 24 in Fig. 1), the at least one of the electrode or the thermocouple comprising a first three-dimensional structure (see shape of microelectrode 40 on tip electrode 24 in Fig. 2) comprising:
a first non-conductive layer (isolating wall 64) in contact with the end effector ([0110]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66), the second layer comprising a non-conductive material ([0100]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66, thus electrically- and thermally-isolating the conducting element from the tip electrode), and
a first electrically conductive layer (a conducting element 66) in contact with the first non-conductive layer ([0100]: Isolating wall 64, which is typically glued to PCB 58, surrounds conducting element 66), the first electrically conductive layer comprising a first electrically conductive material (conducting element 66), and
a unitary structure (ring electrode 21, slotted tube 46 & strain gauge 48; wherein the ring electrode & strain gauge being disposed on the slotted tube is seen collectively as a unitary structure) on the catheter body and comprising a respective force sensor (strain gauge 48; [0104]: strain gauge 48 being configured to measure the strain in the bridge to which the strain gauge is coupled. As described above, these measurements may be used to estimate the force applied to the tissue by the catheter during the ablation procedure) and a respective position sensor (ring electrode 21; [0106]: Ring electrodes 21 may be used, for example, for ECG-signal acquisition, or injection of current for impedance-based location-sensing), the unitary structure comprising a second three-dimensional structure (see 3D structure of slotted tube & strain gauge 48 in Fig. 3) comprising:
a super elastic layer (slotted tube 46) in contact with a surface of the catheter body ([0104]: a slotted tube 46, which is typically situated at a distal portion of the catheter, such as immediately proximally to, and/or partly underneath, tip electrode 24; wherein the tip electrode 24 is an outer surface of the catheter body), the super elastic layer comprising a super elastic material ([0104]: Typically, slotted tube 46 is metallic; for example, the slotted tube may be manufactured from any suitable metallic alloy, such as nitinol),
a second non-conductive layer in contact with a surface of the of the super elastic layer, the second non-conductive layer comprising a non-conductive material ([0119]: For example, each strain gauge shown in FIG. 3 comprises a resistor 76. As the shape of the strain gauge changes due to the strain in the bridge, the resistance of resistor 76 changes. Via PCB 58, a voltage may be applied across the strain gauge, such that the measured current flowing through the strain gauge indicates the change in resistance of the strain gauge, and hence, the strain in the bridge; wherein it is known that strain gauges comprise a resistor on an insulative/dielectric substrate such that the stretching/compression of the sensor causes increases/decreases in resistance of the resistor and therefore while not explicitly described, the strain gauge 48 comprises a resistor 76 on an insulative substrate & the strain gauge (including the insulative substrate) is on slotted tube 46, see Fig. 3), and
a second electrically conductive layer in contact with the second non-conductive layer, the second electrically conductive layer comprising a second electrically conductive material ([0119]: For example, each strain gauge shown in FIG. 3 comprises a resistor 76. As the shape of the strain gauge changes due to the strain in the bridge, the resistance of resistor 76 changes. Via PCB 58, a voltage may be applied across the strain gauge, such that the measured current flowing through the strain gauge indicates the change in resistance of the strain gauge, and hence, the strain in the bridge. Alternatively, a current may be applied across the strain gauge, such that the measured voltage across the strain gauge indicates the change in resistance of the strain gauge. This measured voltage or current is referred to herein as the “signal,” output by the strain gauge, that indicates the strain in the bridge; wherein the resistor 76 comprises a conductive material since the current across it is measured).
Regarding claim 18, Bar-Tal teaches wherein the first non-conductive layer (isolating wall 64) of the first three-dimensional structure is in contact with an inner surface of the end effector or an outer surface of the end effector ([0110]: each microelectrode is cylindrically shaped, whereby isolating wall has an annular shape, and the outer surface of conducting element 66, which forms the top of the cylinder, is circular. Typically, the diameter of the microelectrode apertures in the tip electrode is only slightly larger than that of the microelectrodes, such that the microelectrodes fit snugly into the apertures. Alternatively or additionally, during the manufacture of catheter 22, the microelectrodes may be glued to, or otherwise fixed to, the respective perimeters of the microelectrode apertures. Thus, the microelectrodes are securely coupled to the tip electrode; wherein the isolating wall 64 is in contact with an inner surface of the tip electrode 24 and the outer surface of the tip electrode 24).
Regarding claim 19, Bar-Tal teaches wherein the super elastic layer (slotted tube 46) of the second three-dimensional structure is in contact with an outer surface of the catheter body or an inner surface of the catheter body (see Fig. 4 where the slotted tube 46 is within the distal end of the catheter 22 such that it is in contact with an inner surface of the catheter body).
Regarding claim 20, Bar-Tal teaches wherein the at least one electrode comprises a sensing electrode ([0110]: Conducting element 66 is typically electrically coupled to PCB 58 (e.g., by being directly connected to the PCB), such that ECG signals detected by the conducting surface may be carried by the PCB from the distal end of the catheter), a reference electrode, or an ablating electrode.
Regarding claim 21, Bar-Tal teaches wherein the super elastic material of the super elastic layer of the second three-dimensional structure comprises nitinol ([0104]: Typically, slotted tube 46 is metallic; for example, the slotted tube may be manufactured from any suitable metallic alloy, such as nitinol).
Regarding claim 22, Bar-Tal teaches wherein the end effector further comprises one or more irrigation openings ([0103]: tip electrode 24 is further shaped to define a plurality of fluid apertures 50).
Claim Rejections - 35 USC § 103
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal as applied to claim 3 above, and further in view of Menon et al. (U.S. Pub. No. 20200323524), herein referred to as “Menon”.
Regarding claim 7, Bar-Tal fails to disclose wherein the at least one force sensor comprises a Rosette strain gauge.
However, Menon discloses wherein the at least one force sensor comprises a Rosette strain gauge ([0084]: In some embodiments, the strain gauges 48 can include uniaxial strain gauges (that is, capable of measuring strain in a single direction) or rosette gauges (that is, two, three, or more gauges positioned at incremental angles relative to one another, capable of measuring strain in two, three, or more directions, respectively)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the force sensor of Bar-Tal to be a rosette strain gauge, as taught by Menon, for the purpose of when a force is applied to the body, such as when a point adjacent the distal end presses against tissue to retract the tissue, the body will slightly deform and one or more of the strain gauges can sense this bending strain. Furthermore, the strain gauges are able to sense these forces despite being applied to the curved surface of the body (i.e., rather than a traditional flat surface) (Menon: [0085]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal as applied to claim 3 above, and further in view of Sterrett et al. (U.S. Pub. No. 20160324474), herein referred to as “Sterrett”.
Regarding claim 15, Bar-Tal fails to disclose wherein the second electrically conductive material is magnetic.
However, Sterrett discloses wherein the second electrically conductive material is magnetic ([0053]: a layer of magnetically-permeable material 60 may be deposited over the second dielectric layer 58). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the second electrically conductive material of Bar-Tal to be magnetic, as taught by Sterrett, for the purpose of the completed coil sensor to be capable of having an electrical signal induced by a magnetic field, and/or to produce a magnetic field according to an electrical signal driven through the sensor (Sterrett: [0053]).
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794