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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/29/2026 has been entered.
Response to Amendment
This action is in response to the RCE filed on 6/29/2026. The amendments filed on 6/29/2026 have been entered. Accordingly Claims 1 and 3-12 are pending. Claim 2 has been cancelled. Claims 13-26 are withdrawn as previously provided. The previous rejections of claims 1 and 3-12 have been withdrawn in light of Applicant’s remarks or/and amendments in the claim set filed 6/29/2026.
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.
Claims 1, 3-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan et. al. (U.S. 20230049942, February 16, 2023)(hereinafter, “Narayan”) in view of Paul et. al. U.S. 20080015568, January 17, 2008)(hereinafter, “Paul”).
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).
With regards to limitation wherein each acoustic sensor comprises a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft, Narayan further teaches: “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].
Narayan is silent with regards to a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft.
Paul in the field of catheter-based systems teaches: “The laminated layers may comprise a piezoelectric material 26 "sandwiched" between metal layers 28a and 28b and protective coating 30a and 30b. Metal layers 28a and 28b may be any suitable metal, e.g., a thin layer of silver ink.” [0044]; “ the piezoelectric material 26 may comprise a thin, flexible, polymer-based material. One such piezoelectric film is a polyvinylidene fluoride (PVDF) film commercially available from the Sensor Products Division of Measurement Specialties, Inc. (Norristown, Pa.). The PVDF film is approximately 28 .mu.m thick, enabling the PVDF film to be readily housed within the catheter shaft 18 (see FIGS. 2a and 2b).” [0046].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each acoustic sensor in Narayan to include a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft as taught in Paul “…for measuring dynamic stresses and strains that a moving tissue may exert on the catheter shaft…” (Paul, [0047]).
Regarding claim 3, the combination of Narayan and Paul teach the claim limitations as noted above.
Narayan further teaches: “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].
Narayan does not teach the piezoelectric polymer film being polyvinylidene.
Paul in the field of catheter-based systems teaches: “The laminated layers may comprise a piezoelectric material 26 "sandwiched" between metal layers 28a and 28b and protective coating 30a and 30b. Metal layers 28a and 28b may be any suitable metal, e.g., a thin layer of silver ink.” [0044]; “ the piezoelectric material 26 may comprise a thin, flexible, polymer-based material. One such piezoelectric film is a polyvinylidene fluoride (PVDF) film commercially available from the Sensor Products Division of Measurement Specialties, Inc. (Norristown, Pa.). The PVDF film is approximately 28 .mu.m thick, enabling the PVDF film to be readily housed within the catheter shaft 18 (see FIGS. 2a and 2b).” [0046].
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 polymer film in the combination to be polyvinylidene as taught in Paul since it is “…a thin, flexible, polymer-based material…” (Paul, [0046]) that “…has a wide frequency range of about 0.001 Hz to 10.sup.9 Hz and a high dynamic stress constant…” (Paul, [0047]).
Regarding claim 4, the combination of Narayan and Paul teach the claim limitations as noted above.
Narayan further teaches: wherein: the shaft includes an inner tube and an outer tube, the respective piezoelectric 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).
Narayan is silent with regards to a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft.
Paul in the field of catheter-based systems teaches: “The laminated layers may comprise a piezoelectric material 26 "sandwiched" between metal layers 28a and 28b and protective coating 30a and 30b. Metal layers 28a and 28b may be any suitable metal, e.g., a thin layer of silver ink.” [0044]; “ the piezoelectric material 26 may comprise a thin, flexible, polymer-based material. One such piezoelectric film is a polyvinylidene fluoride (PVDF) film commercially available from the Sensor Products Division of Measurement Specialties, Inc. (Norristown, Pa.). The PVDF film is approximately 28 .mu.m thick, enabling the PVDF film to be readily housed within the catheter shaft 18 (see FIGS. 2a and 2b).” [0046].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each acoustic sensor in Narayan to include a piezoelectric polymer film disposed about at least a portion of a circumference of the shaft as taught in Paul “…for measuring dynamic stresses and strains that a moving tissue may exert on the catheter shaft…” (Paul, [0047]).
Regarding claim 5, the combination of Narayan and Paul teach 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, the combination of Narayan and Paul teach 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, the combination of Narayan and Paul teach 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).
Regarding claim 11, the combination of Narayan and Paul teach the claim limitations as noted above.
Narayan further teaches: : wherein the housing includes a port having a hole that is aligned with a central channel of the shaft (“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]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan and Paul 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, the combination of Narayan and Paul teach 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].
The combination 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 the combination 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, Paul 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, Paul 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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan and Paul 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, the combination of Narayan, Paul and Heimbecher teach 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.
The combination 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 the combination of references to include first and second acoustic sensors as taught in Anderson for acoustic time of flight measurement (Anderson, [0122]).
Response to Arguments
Applicant’s arguments regarding the pending claims are moot in view of the new grounds of rejections.
Conclusion
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/AMAL ALY FARAG/ Primary Examiner, Art Unit 3798
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