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
This action is in response to remarks filed on 03/02/2026. The remarks have been entered. Claims 1-12 are pending. Claims 13-26 are withdrawn as previously provided.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-2 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Narayan et. al. (U.S. 20230049942, February 16, 2023)(hereinafter, “Narayan”).
Regarding claim 1, Narayan teaches: A catheter (Fig. 1, element 155, catheter, [0108]) comprising: a shaft (Fig. 1, element 150, shaft, [0108]);
a tip disposed at a distal end of the shaft (“The steering wire lumens 340 provide a cavity for steering wires to be disposed. The steering wires are connected to the steering ring 330 at a distal end of the shaft 150, i.e., in proximity to the catheter 155…” [0127]; “…a proximal end 402 of the catheter 400 is towards the shaft 150 and the handle 145, whereas a distal end 404 of the catheter 400 is opposite from the proximal end 402.” [0135]. see Figs. 1 and 3-4);
at least one acoustic sensor disposed on or in the shaft, each acoustic sensor disposed at a respective distance from the distal end of the shaft (“The catheter 400 comprises, among other components, a plurality of splines 420, a plurality of connectors 430, an electrode array 440, and irrigation pores 450. Other sensors in some embodiments include temperature sensors, force-sensing elements, photoelectric sensors to identify changes to tissue composition prior to and during ablation to verify treatment effect.” [0134]); and
at least one electrical conductor disposed on or in the shaft, each electrical conductor electrically connecting a respective acoustic sensor to one or more electrical connection points in a housing attached to a proximal end of the shaft (“The conductor wires 360 are conductive and configured to transmit electrical energy between the electrode array of the catheter 155 and the handle 145. The conductor wires 360 are formed of conductive materials, e.g., copper, gold, platinum, other conductive metals, other conductive metal alloys, etc.” [0129]; “Each electrode of the electrode array 440 is capable of sensing electrical signals of the heart tissue and for delivering ablation energy to the heart tissue. Each electrode is formed from a conductive material coupled circumferentially to the respective spline that the electrode is disposed on.” [0147]. See Figs. 3-4).
Regarding claim 2, Narayan teaches the claim limitations as noted above.
Narayan further teaches: wherein each acoustic sensor comprises a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft (“The internal housing 310 and the external housing 320 form the structural support for the shaft 150…On an internal surface of the internal housing 310 is an internal liner 325. The internal liner 325 may be sufficiently waterproof to prevent liquids from entering the cavity within the internal housing 310. Example material for the internal liner 325 may be polytetrafluoroethylene (PTFE) which is a synthetic fluoropolymer with hydrophobic properties.” [0125-0126];“The measured contact force can be used to verify contact between the catheter 400 and the tissue during sensing and/or ablation. The force-sensing elements may be piezoelectric sensors…” [0154]. See Figs. 3-4).
Regarding claim 4, Narayan teaches the claim limitations as noted above.
Narayan further teaches: wherein: the shaft includes an inner tube and an outer tube, the respective piezoelectric polymer film is disposed about at least a portion of a circumference of the inner tube, and the at least one electrical conductor is disposed between the inner and outer tubes (“The internal housing 310 and the external housing 320 form the structural support for the shaft 150…On an internal surface of the internal housing 310 is an internal liner 325. The internal liner 325 may be sufficiently waterproof to prevent liquids from entering the cavity within the internal housing 310. Example material for the internal liner 325 may be polytetrafluoroethylene (PTFE) which is a synthetic fluoropolymer with hydrophobic properties.” [0125-0126];“The measured contact force can be used to verify contact between the catheter 400 and the tissue during sensing and/or ablation. The force-sensing elements may be piezoelectric sensors…” [0154] See Figs. 3-4).
Regarding claim 5, Narayan teaches the claim limitations as noted above.
Narayan further teaches: wherein: the inner tube is defined by a wall having an inner-wall thickness, and one or more regions of the wall have an increased thickness compared to the inner- wall thickness (“The shaft 300 is a strong and flexible cylinder that extends from the handle 145 to the catheter 155. The shaft 300 has a length to ensure that the catheter 155 can be inserted at an access point of the patient and reach the heart tissue to be treated. The shaft 300 comprises, among other components, an internal housing 310, an external housing 320, an internal liner 325, a steering ring 330, steering wire lumens 340, an anchor 350, conductor wires 360, and irrigation lumens…The internal housing 310 and the external housing 320 form the structural support for the shaft 150. The internal housing 310 and the external housing 320 may be formed from sufficiently strong yet flexible material…” [0124-0125]. See Figs. 3).
Regarding claim 6, Narayan teaches the claim limitations as noted above.
Narayan further teaches: wherein: the outer tube is defined by a wall having an outer-wall thickness, and one or more regions of the wall have an increased thickness compared to the outer-wall thickness (“The shaft 300 is a strong and flexible cylinder that extends from the handle 145 to the catheter 155. The shaft 300 has a length to ensure that the catheter 155 can be inserted at an access point of the patient and reach the heart tissue to be treated. The shaft 300 comprises, among other components, an internal housing 310, an external housing 320, an internal liner 325, a steering ring 330, steering wire lumens 340, an anchor 350, conductor wires 360, and irrigation lumens…The internal housing 310 and the external housing 320 form the structural support for the shaft 150. The internal housing 310 and the external housing 320 may be formed from sufficiently strong yet flexible material…” [0124-0125]. See Figs. 3).
Regarding claim 7, Narayan teaches the claim limitations as noted above.
Narayan further teaches: wherein a spacer is disposed between the inner and outer tubes: (“The shaft 300 is a strong and flexible cylinder that extends from the handle 145 to the catheter 155. The shaft 300 has a length to ensure that the catheter 155 can be inserted at an access point of the patient and reach the heart tissue to be treated. The shaft 300 comprises, among other components, an internal housing 310, an external housing 320, an internal liner 325, a steering ring 330, steering wire lumens 340, an anchor 350, conductor wires 360, and irrigation lumens…The internal housing 310 and the external housing 320 form the structural support for the shaft 150. The internal housing 310 and the external housing 320 may be formed from sufficiently strong yet flexible material…” [0124-0125]; “The catheter 400 is shown in an expanded state, wherein the catheter 400 is unsheathed from the sheath 410, i.e., extended away from the sheath 410. The catheter 400 comprises, among other components, a plurality of splines 420, a plurality of connectors 430, an electrode array 440, and irrigation pores 450.” [0134]. See Figs. 3-4).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Bjurbo et. al. (U.S. 20220031278, February 3, 2022)(hereinafter, “Bjurbo”).
Regarding claim 3, Narayan teaches the claim limitations as noted above.
with respect to limitation: wherein the piezoelectric polymer film comprises polyvinylidene fluoride, Narayan teaches: “The internal housing 310 and the external housing 320 form the structural support for the shaft 150…On an internal surface of the internal housing 310 is an internal liner 325. The internal liner 325 may be sufficiently waterproof to prevent liquids from entering the cavity within the internal housing 310. Example material for the internal liner 325 may be polytetrafluoroethylene (PTFE) which is a synthetic fluoropolymer with hydrophobic properties.” [0125-0126].
Narayan does not teach the fluoride being polyvinylidene.
Bjurbo in the field of catheter systems teaches a catheter guidance system with a membrane formed from a piezoelectric material such as polyvinylidene fluoride polymer [0056].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the piezoelectric material in Narayan of polytetrafluoroethylene fluoride to polyvinylidene fluoride as taught in Bjurbo for the good insulation, strength and lower temperature limit capabilities provided by the material.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan as applied to claim 1 above, and further in view of Heimbecher et. al. (U.S. 20140364848, December 11, 2014)(hereinafter, “Heimbecher”).
Regarding claim 8, Narayan teaches the claim limitations as noted above.
With regards to limitations, wherein the one or more electrical connection points is/are electrically coupled to a cable that extends through the housing, Narayan further teaches: “The handle 200 comprises a housing 205, a steering knob 210, an irrigation port 220, an electrical port 230, and a strain relief 240.” [0115]; “The electrical port 230 provides a connection between electrical wiring from the generator 115 and the electrical wiring within the housing 205. Electrical energy that is provided from the generator 115 is directed, at the electrical port 230, into the plurality of electrical wires in the housing 205 that are connected to the electrode array of the catheter 155.” [0119]; “The conductor wires 360 are conductive and configured to transmit electrical energy between the electrode array of the catheter 155 and the handle 145.” [0129].
Narayan does not explicitly teach a cable that extends through the housing.
Heimbecher in the field of catheter systems for diagnosis or treatment teaches: “ Catheter 20 is also electrically connected to ablation generator 22 for delivery of RF energy. Catheter 20 may include a cable connector or interface 48, a handle 50, a shaft 52 having a proximal end 54 and a distal end 56…” [0069].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the housing of Narayan to include a cable that extends through the housing as taught in Heimbecher to allow the catheter components to be electrically connected for energy delivery (Heimbecher, [0069]).
Regarding claim 9, the combination of Narayan and Heimbecher teach the claim limitations as noted above.
Narayan further teaches: wherein the one or more electrical connection points is/are formed on a printed circuit board disposed in the housing (“The catheter 1800 comprises an inflatable member 1820 and a flexible circuit 1815… The flexible circuit 1815 is also composed of a pliable material. The flexible circuit 1815 may comprise an insulative base with the circuit printed onto the insulative base. The electrode array 1840 may also be printed onto the insulative base. The electrodes 1842 may be evenly distributed in a rectangular array, as shown in FIG. 18.” [0226].).
Regarding claim 10, the combination of Narayan and Heimbecher teach the claim limitations as noted above.
Narayan further teaches: further comprising wireless communication circuitry electrically coupled to the one or more electrical connection points (“The network 130 provides connections to the components of the treatment system 100 through one or more sub-networks, which may include any combination of local area and/or wide area networks, using both wired and/or wireless communication systems.” [0113]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Narayan.
Regarding claim 11, Narayan teaches the claim limitations as noted above.
Narayan in the above embodiment does not teach: wherein the housing includes a port having a hole that is aligned with a central channel of the shaft.
However, Narayan in a different embodiment teaches: “The heart treatment device 105 (or more generally the treatment device) comprises a handle 145, a shaft 150, and a catheter 155...” [0114]; “ The handle 200 comprises a housing 205, a steering knob 210, an irrigation port 220, an electrical port 230, and a strain relief 240.” [0115]; “The irrigation port 220 provides a connection of an irrigant fluid channel from the irrigation pump 120 to the irrigant fluid channel within the housing 205. The irrigant fluid channel within the housing 205 and routed to the catheter 155 also connect to the irrigation port 220. Irrigant that is pumped from the irrigation pump 120 flows through the fluid channel, through the irrigation port 220, and into the fluid channel routed to the catheter 155, where irrigant can be dispensed by the catheter 155…” [0118].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the housing in Narayan to include a port having a hole that is aligned with a central channel of the shaft as taught in a different embodiment of Narayan to incorporate different components to the housing that can affect various functions of the catheter such as movement, steering, fluid dispersion, etc. (Narayan, [0117-0119]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan as applied to claim 1 above, and further in view of Anderson et. al. (U.S. 20070213616, September 13, 2007)(hereinafter, “Anderson).
Regarding claim 12, Narayan teaches the claim limitations as noted above.
with regards to limitation, wherein the at least one acoustic sensor includes first and second acoustic sensors, the first and second sensors separated by a predetermined distance, Narayan further teaches: “The catheter 400 comprises, among other components, a plurality of splines 420, a plurality of connectors 430, an electrode array 440, and irrigation pores 450. Other sensors in some embodiments include temperature sensors, force-sensing elements, photoelectric sensors to identify changes to tissue composition prior to and during ablation to verify treatment effect.” [0134]. See Figs. 3-4.
Narayan does not explicitly teach first and second acoustic sensors.
Anderson in the field of catheter systems teaches a catheter with multiple acoustic sensors on an array on a therapeutic applicator [0122].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the acoustic sensor in Narayan to include first and second acoustic sensors as taught in Anderson for acoustic time of flight measurement (Anderson, [0122]).
Response to Arguments
With regards to Applicant’s 32U.S.C. 102 arguments regarding Narayan not teaching claim 1 limitation “…at least one acoustic sensor disposed on or in the shaft…”, Examiner respectfully disagrees that at least one sensor is not acoustic.
Narayan from various passages in the disclosure provide teachings that support having at least one acoustic sensor, for example Narayan teaches: “Breath sensors can detect movement of the chest wall, abdomen or other body parts associated with ventilation, or acoustic data (sound) associated with breaths, or oxygenation associated with breathing.” [0104]; “Acquired signals are detected in a transformed state, such as an ECG recording. Such signals may be biological, since cardiac bioelectricity generates the ECG, or non-biological signals, e.g., vibration sensed after application of sonic or ultrasonic energy, or a haptic signal transduced from a sensed electrical, sonic or another signal.” [105]; “The catheter 400 comprises, among other components, a plurality of splines 420, a plurality of connectors 430, an electrode array 440, and irrigation pores 450. Other sensors in some embodiments include temperature sensors, force-sensing elements, photoelectric sensors to identify changes to tissue composition prior to and during ablation to verify treatment effect.” [0134] and “The measured contact force can be used to verify contact between the catheter 400 and the tissue during sensing and/or ablation. The force-sensing elements may be piezoelectric sensors, surface capacitance sensors, etc.” [0154]. These passages, which are among those cited above, provide support that Narayan meets the teachings of the claim 1 limitation, “…at least one acoustic sensor disposed on or in the shaft…”. Applicant’s arguments respectfully, appear to be a narrower interpretation of the claim 1 limitation.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798