DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 2-6, 9-13, and 16-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brisken et al., (US 20020099292; hereinafter Brisken) in view of Vanney et al., (US 20120197141; hereinafter Vanney), Hashimshony et al., (US 20120123296; hereinafter Hashimshony), Yagi et al, (US 20060058676; hereinafter Yagi), and Honour et al., (US 20070219551; hereinafter Honour).
Regarding claim 2, Brisken (Figures 11A-12) discloses a device (248) that is configured to be inserted into a body lumen, comprising: an elongate shaft comprising a proximal end and a distal portion; an expandable assembly (250) positioned on the distal portion of the elongate shaft and configured to transition from a radially compact state to a radially expanded state, wherein the expandable assembly (250) comprises a plurality of splines (242); a plurality of electrodes (252) and a plurality of ultrasound transducers (254) positioned on the plurality of splines (242) and configured to at least on of receive or transmit electrical signals ([0121]-[0122], [0144]: as shown in Figure 12, each arm/spline may include at least two electrodes and at least two ultrasound transducers), wherein each of the plurality of ultrasound transducers (254) comprise a first terminal and a second terminal; and a plurality of communication paths (leads) selectively coupling the plurality of electrodes (252) and the plurality of ultrasound transducers (254) to an electronic module (tracking system) configured to process the electrical signals, wherein the plurality of communications paths (leads) comprises a first set of conductors (leads connecting the electrodes and the first terminals of the transducers to the electronic module) and a second set of conductors (leads connecting the second terminals of the transducers to the electronic module), wherein the plurality of electrodes and the first terminals of the plurality of ultrasound transducers are coupled to the conductors of the first set of conductors (through the electronic module), and the second terminals of the plurality of ultrasound transducers are coupled to the conductors of the second set of conductors (through the electronic module), ([0091], [0106]-[0122], [0136]).
Brisken fails to disclose one or more coaxial cables each comprising an inner conductor and a shield, wherein at least one of the first set of conductors comprises the inner conductor of one of the one or more coaxial cables, and at least one of the second set of conductors comprises the shield of one of the one or more coaxial cables, wherein the one or more coaxial cables comprise at least two coaxial cables. However, Vanney (Figures 36-37) teaches an electrosurgical device configured to be inserted into a body lumen, comprising one or more coaxial cables (200) each comprising an inner conductor (435) and a shield (440), wherein the one or more coaxial cables (200) comprise at least two coaxial cables, wherein at least one of the first set of conductors comprises the inner conductor of one of the one or more coaxial cables (200), and at least one of the second set of conductors comprises the shield of one of the one or more coaxial cables (200), ([0115], [0117]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brisken to include one or more coaxial cables comprising the communication paths, as taught by Vanney, because the modification would provide shielded communication paths (Vanney; [0115], [0117]) to protect the device.
Brisken/Vanney fails to teach that the coaxial cables are connected to electrodes. However, Hashimshony teaches an electrosurgical device configured to be inserted into a body lumen, wherein coaxial cables are configured to connect electrodes within the device ([0008]-[0012], [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brisken/Vanney to such that the coaxial cables are configured to connect to electrodes, as taught by Hashimshony, because the modification would provide controlled impedance signal transmission structures (Hashimshony; [0008]) connecting the electrodes. Furthermore, the inner conductor of the modified device would connect the electrodes and the first terminals of the transducers to the electronic module, while the shield would connect the second terminals of the transducers to the electronic module. Therefore, in the modified device, at least one of the first set of conductors (which connect the electrodes and the first terminals of the transducers to the electronic module) would comprise the inner conductor of one of the one or more coaxial cables, and at least one of the second set of conductors (which connect the second terminals of the transducers to the electronic module) would comprise the shield of one of the one or more coaxial cables.
Brisken/Vanney/Hashimshony fails to teach that the shield of one of the two or more coaxial cables is electrically connected to the shield of another of the two or more coaxial cables. However, Yagi (Figure 12) teaches an electrosurgical device in which the shields (20, 21) of two or more coaxial cables ([0047]) are electrically connected to each other through a ground line grounding the signal ([0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brisken/Vanney/Hashimshony such that the shield of one of the two or more coaxial cables is electrically connected to the shield of another of the two or more coaxial cables through a ground line, as taught by Yagi, because the modification would prevent crosstalk in signal transmission (Yagi; [0031]).
Brisken (Figures 11A-12) further discloses a flexible printed circuit board substrate (260) coupled to the plurality of splines (242) of the expandable assembly (250), but Brisken/Vanney/Hashimshony/Yagi fails to teach that they are coupled via one or more attachment elements, wherein the one or more attachment elements are positioned at one or more discrete attachment locations to allow for independent flexing of the flexible printed circuit board substrate and the plurality of splines. However, Honour (Figure 8) teaches a device for mapping/ablation, wherein a flexible printed circuit board (PCB) substrate (34) coupled to the discrete portions of an end effector (42) via one or more attachment elements (68) attaching individual traces (36) of the PDB to respective electrodes (44) of the end effector (42); wherein the one or more attachment elements (68) are positioned at one or more discrete attachment locations (corresponding to respective electrode locations on the end effector), ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the general PCB structure disclosed by Brisken with a discrete PCB structure attached at different attachment locations on the end effector, as taught by Honour, since both PCB structures perform the same function of providing flexible mechanical support and electrical connectivity for electronic components and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, since the modified device would include the PCB coupled to the plurality of splines of the expandable assembly via one or more attachment elements positioned at one or more discrete attachment locations, there would be independent flexing of the flexible printed circuit board substrate and the plurality of splines in the areas where the elements are not attached.
Regarding claim 3, Brisken (Figures 11A-12) further discloses wherein each conductor of the first set of conductors is coupled to an electrode of the plurality of electrodes (252), and the first terminal of an ultrasound transducer (254) of the plurality of ultrasound transducers ([0091], [0106]-[0122], [0136]).
Regarding claim 4, Brisken (Figures 11A-12) further discloses wherein each conductor of the second set of conductors is coupled to the second terminal of two or more of the plurality of ultrasound transducers (254), ([0091], [0106]-[0122], [0136])..
Regarding claim 5, Brisken (Figures 11A-12) further discloses wherein each of the two or more ultrasound transducers (254) are individually addressable by the electronic module (tracking system), ([0091], [0106]-[0122], [0136]).
Regarding claim 6, Brisken (Figures 11A-12) further discloses wherein the plurality of electrodes (252) and the plurality of ultrasound transducers (254) are coupled to the flexible printed circuit board substrate (260), and at least a portion of the plurality of communication paths (leads) are positioned at least one of on or within the flexible printed circuit board substrate (260), ([0091], [0106]-[0122], [0136]).
Regarding claim 9, Brisken (Figures 11A-12) further discloses wherein the flexible printed circuit board substrate (260) comprises materials selected from a group comprising: polyimide; polyester; nylon; Pebax; liquid crystal polymer; and combinations thereof ([0106]-[0122], [0126]).
Regarding claim 10, Brisken (Figures 11A-12) further discloses wherein the device comprises a dipole mapping device ([0088], [0115]).
Regarding claim 11, Brisken (Figures 11A-12) further discloses wherein the plurality of electrodes (252) comprises at least 8 electrodes, and the plurality of ultrasound transducers (254) comprises at least 8 transducers ([0091], [0106]-[0122], [0136]; Figure 12 shows that there are at least 8 electrodes and at least 8 transducers).
Regarding claim 12, Brisken (Figures 11A-12) further discloses wherein the plurality of splines (242) comprises at least two splines (242) with at least two ultrasound transducers (254) positioned on each of the at least two splines (242), ([0091], [0106]-[0122], [0136]).
Regarding claim 13, Brisken (Figures 11A-12) further discloses wherein the at least two ultrasound transducers (254) mounted to a first spline (242) are linearly staggered from the at least two ultrasound transducers mounted to a second spline (242), such that a protrusion of an ultrasound transducer (254) on the first spline (242) extends between protrusions of the at least two ultrasound transducers (254) on the second spline ([0106]-[0120]: since the at least two ultrasound transducers of the first and second splines would be linearly staggered from each other, this offset would locate the one ultrasound transducer of one spline between at least two ultrasound transducers of another spline; the protrusion of the one ultrasound transducer on the one spline would therefore extend between the protrusion of the at least two ultrasound transducers of the other spline).
Regarding claim 16, Brisken/Vanney/Hashimshony/Yagi/Honour further teaches wherein the one or more attachment elements (Honour; 68) allow for independent flexing of the flexible printed circuit board substrate (Honour; 34) and the plurality of splines (Brisken; 242) alongside (next to) the one or more attachment elements (Honour; 68).
Regarding claim 17, Brisken/Vanney/Hashimshony/Yagi/Honour further teaches wherein the one or more attachment elements (Honour; 68) allow for independent flexing of the flexible printed circuit board substrate (Honour; 34) and the plurality of splines (Brisken; 242) in-between (next to) the one or more attachment elements (Honour; 68).
Regarding claim 18, Brisken/Vanney/Hashimshony/Yagi/Honour further teaches wherein the one or more attachment elements (Honour; 68) are selected from the group consisting of: an adhesive; a clip; a crimp; and combinations thereof ([0083]: solder).
Claims 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brisken/Vanney/Hashimshony/Yagi/Honour, as applied to claim 2, and further in view of Griffith et al., (US 4841977; hereinafter Griffith).
Regarding claim 7, Brisken/Vanney/Hashimshony/Yagi/Honour teaches the device of claim 2, but fails to disclose that each of the plurality of ultrasound transducers comprises as matching layer. However, Griffith teaches (Figure 1) a catheter device configured to be inserted into a body lumen, wherein at least one of a plurality of ultrasound transducers (70) comprises a matching layer (128), (Col. 15, line 67 – Col. 16, line 2; Col. 17, lines 26-51). Therefore, it would have been obvious to one having ordinary skill in the art at the time if the invention to modify Brisken/Vanney/Hashimshony/Yagi/Honour to include at least one of the plurality of ultrasound transducers comprising a matching layer, as taught by Griffith, because the modification would allow for more efficient transfer of energy between the active element and its surrounding media, thus increasing the sensitivity and efficiency of the at least one of the plurality of ultrasound transducers (Griffith; Col. 17, lines 48-51).
Regarding claim 8, Brisken/Vanney/Hashimshony/Yagi/Honour/Griffith teaches wherein the matching layer comprises at least a portion of the flexible printed circuit board substrate. Specifically, the matching layer taught by Griffith would be integrated into the flexible printed circuit board substrate of the modified device to maintain functionality of the active elements.
Response to Arguments
Applicant’s arguments filed 03/26/2026 have been fully considered.
In response to Applicant’s argument that Yagi does not disclose coaxial cable shields being electrically connected to one another since Yagi discloses hierarchical shielding layers, namely a first shield material 20 and a second shield material 21, that wrap around a flexible printed circuit board assembly, Examiner respectfully disagrees. Yagi is not used to teach that the first and second shield materials (20, 21) of one coaxial are electrically connected to one another. Rather, Yagi is used to teach that the shields (20, 21) of different coaxial cables are electrically connected to one another through a ground line grounding the signal. Therefore, Examiner maintains that the Brisken/Vanney/Hashimshony/Yagi combination remains tenable.
However, Applicant’s argument with regard to the newly added claim limitations is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Honour, which teaches a device for mapping/ablation, wherein a flexible PCB substrate is coupled to the discrete portions of an end effector via one or more attachment elements attaching individual traces of the PCB to respective electrodes of the end effector; wherein the one or more attachment elements are positioned at one or more discrete attachment locations. In combination with Brisken/Vanney/Hashimshony/Yagi, the modified device teaches the invention as claimed at least in the amended set of claims.
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.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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