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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Response to Amendment
This office action is in response to the communications filed on 12/01/2025 and 12/30/2025, concerning Application No. 18/634,758. The amendments to the claims filed on 12/01/2025 are acknowledged. Presently, claims 1, 3, and 5-20 remain pending.
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, 3, 5, and 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sliwa, Jr. et al. (US Patent No. 5,575,288 A, of record, hereinafter Sliwa).
Regarding independent claims 1, 14, and 18, Sliwa discloses a medical imaging device (probe 20) (see, e.g., Figs. 1-3 and 12-17), a corresponding medical imaging system (see, e.g., Abstract, and Col. 4, lines 3-10), and a corresponding method for manufacturing a medical imaging device (see, e.g., Abstract, and Col. 10, lines 51-63), the medical imaging device (20) comprising:
an ultrasound transducer (acoustic device 40, multielement transducer 60) having an acoustic stack comprising an active surface (60) opposite a backing surface (ultrasonically attenuative backing material 66) (see, e.g., Col. 5, lines 20-24, “FIG. 3 is a side view of the ultrasonic scanhead 28 shown in FIG. 2. The acoustic device 40 has a multielement transducer 60 mounted on a base 62. The base 62 comprises a container 64 that is filled with an ultrasonically attenuative backing material 66”, and Figs. 3 and 12-17);
a magnetic tracking sensor assembly (magnetic position sensor 146) (see, e.g., Col. 16, lines 19-52, “the attenuative backing material 66 is placed in the container 64 above a magnetic position sensor 146. The magnetic position sensor 146 rotates with the multielement transducer 60 as both are rigidly attached to the rotating container 64. A remote transmitter (not shown) generates magnetic fields that are detected by the magnetic position sensor 146 attached to the container 64. The magnetic position sensor 146 may be electrically connected […] The magnetic position sensor 146 is capable of indicating the rotational and angular position of the transducer 60, as well as the position of the scanhead 36 within the patient. […] The magnetic position sensor 146 may also be used to trigger the acquisition of multiple parallel image planes obtained as the scanhead 28 is dragged axially along the esophagus wall with its imaging plane generally perpendicular to the direction of dragging. […] The container 64 and the circular tracks 68 and 68' may be fabricated from a ceramic material or non-magnetic metal because the magnetic position sensor 146 may be sensitive to surrounding metallic objects”, and Fig. 17); and
a layered circuit assembly (flexible assembly 42 comprising layers of flexible circuitry 41, 43, and comprising traces 82, 84) (see, e.g., Col. 4, lines 58-62, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein”, and Col. 6, lines 15-18, “At the distal end of the flexible assembly 42, the flex interconnect traces 82 are connected to mating electrically conductive traces 84 on or within the container 64 of the acoustic device 40”) including a flexible circuit (see, e.g., Col. 4, lines 58-62, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein”) having a plurality of sets of longitudinally extending conductive elements (plurality of flex interconnect traces 82) disposed between longitudinally extending perforations (see, e.g., Col. 4, lines 58-67 and Col. 5, lines 1-19, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein […] The flex interconnect traces 82 may be fabricated using conventional thin-film, thick-film or additive/subtractive plating process techniques while the flexible assembly 42 and carrier band 120 are in a flat state. Typically, the interconnect traces 82 are thin, metallic, fatigue-resistant and lithographically formed interconnects made from gold, copper or alloys thereof. The optimal thickness of the interconnect traces 82 is approximately 5 to 35 microns. The traces 82 preferably have a net compressive stress as formed in the flat state. The net compressive stress insures that for all points along the length of the flex interconnect traces 82 contained in the movable portion of the flexible assembly 42, the flex interconnect traces 82 remain in a compressive state regardless of the position of the movable portion of the flexible assembly 42. The carrier band 120, if laminated to the face of the flexible assembly 42 that is convex on the movable portion of the flexible assembly 42, will also tend to insure the preferred compressive stress states in the flex interconnect traces 82”, and Col. 9, lines 42-46, “FIG. 12 also shows the flexible assembly 42, having flex interconnect traces 82, described above with reference to FIGS. 2 and 3. In the embodiment of FIG. 12, the flex interconnect traces 82 are disposed on one or both (shown) faces of the flexible assembly 42”, and Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Figs. 3, 12, 16-17, and 19-20; Examiner notes that the plurality of flex interconnect traces 82 as taught by Sliwa are disclosed to be formed thereon or therein one of the layers of the flexible circuitry 41, 43, such that the flex interconnect traces 82 may be fabricated using additive/subtractive plating process techniques while the flexible assembly 42 and carrier band 120 are in a flat state, and that the Examiner’s interpretation is that the plurality of flex interconnect traces 82 can be formed thereon or therein the flexible circuitry 41, 43 using an additive or subtractive plating process, and therefore, after the plurality of flex interconnect traces 82 are formed/fabricated, there would inherently be a space/gap/section/perforation/etc. on the flexible circuitry 41, 43 in portions that are in between each of the plurality of flex interconnect traces 82 formed/fabricated thereon or therein the flexible circuitry 41, 43),
the layered circuit assembly (flexible assembly 42 comprising layers of flexible circuitry 41, 43, and comprising traces 82, 84) being electrically and mechanically coupled to the ultrasound transducer (60) on a first side and to the magnetic tracking sensor assembly (146) on an opposite, second side (see, e.g., Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Figs. 3, 12, 16-17, and 19, where the flex interconnect traces 82 are positioned on the flexible assembly 42 and the electrically conductive traces 84 are positioned on the outer surface of the container 64, such that the electrically/mechanical couplings to the transducer 60 and the magnetic position sensor 146 via the flex interconnect traces 82 positioned on the flexible assembly 42 and the electrically conductive traces 84 positioned on the outer surface of the container 64 can be coupled on different/opposite sides/surfaces/ends of the respective traces 82, 84),
the magnetic tracking sensor assembly (146) having a coupling surface, wherein the backing surface (66) aligns with the coupling surface (see, e.g., Col. 16, lines 19-31, “the attenuative backing material 66 is placed in the container 64 above a magnetic position sensor 146. The magnetic position sensor 146 rotates with the multielement transducer 60 as both are rigidly attached to the rotating container 64. A remote transmitter (not shown) generates magnetic fields that are detected by the magnetic position sensor 146 attached to the container 64. The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Fig. 17).
Regarding claim 3, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa further discloses wherein the flexible circuit (flexible assembly 42 comprising layers of flexible circuitry 41, 43) includes a first portion coupled to a folded stack, wherein the magnetic tracking sensor assembly (magnetic position sensor 146) and the ultrasound transducer (acoustic device 40, multielement transducer 60) are electrically coupled to the first portion, and the folded stack is folded underneath the first portion (see, e.g., Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Col. 19, lines 18-42, “In FIG. 20A, an alternative construction of the acoustic device 40 is provided that allows a direct connection between the flexible assembly 42, which may form the rolling loop regions 170, 172, and the multielement transducer 60. The attenuative backing material 66 is approximately hexagonal in shape. A first flexible assembly 42 is bonded to the top of the attenuative backing material 66 with the flex interconnect traces 82 facing upward. The first flexible assembly 42 is then folded over one of the flat faces of the hexagonal attenuative backing material 66. An additional fold at the bottom of the flat face may allow the flexible assembly 42 to be routed beneath the acoustic device 40 where an integral rolling deformable loop, such as 170 in FIGS. 19 and 20, may be formed. A second flexible assembly 42' (not shown) is bonded to the top of the attenuative backing material 66 directly opposite to the first flexible assembly 42 and is folded over the opposite flat face of the hexagonal material 66. The second flexible assembly 42' may also be routed beneath the acoustic device 40, where an integral rolling deformable loop, such as 172 in FIGS. 19 and 20, may be formed. The multielement transducer 60 is bonded to the top of the first and second flexible assemblies 42, 42'. The container 64 surrounds the hexagonal faces of the attenuative backing material 66, which have the flexible assemblies 42, 42' bonded thereto”, and Figs. 17 and 20A).
Regarding claim 5, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa further discloses wherein the ultrasound transducer (acoustic device 40, multielement transducer 60) and the magnetic tracking sensor assembly (magnetic position sensor 146) each include a plurality of electrical connections (electrically conductive traces 84) electrically coupled to the longitudinally extending conductive elements (plurality of flex interconnect traces 82) (see, e.g., Col. 6, lines 15-18, “At the distal end of the flexible assembly 42, the flex interconnect traces 82 are connected to mating electrically conductive traces 84 on or within the container 64 of the acoustic device 40”, and Col. 10, lines 26-33, “FIGS. 13 and 14 show the electrically conductive traces 84 that have been formed on the outer surface of the container 64 as discussed above with respect to FIG. 3 and as shown in FIGS. 3 and 12. Preferably, the conductive traces 84 pass over the top edge of the cylindrical container 64 as shown in FIG. 13. A metal film layer 124 interconnects the electrically conductive traces 84 and the multielement transducer 60”, and Col. 12, lines 16-23, “As described with reference to FIGS. 13 through 15, the electrically conductive traces 84 are electrically connected to the electrically independent elements 130 of the multielement transducer 60, either directly or through metal film layer 124. The electrical connection to each electrically independent element 130 of the multielement transducer 60 enables each element 130 to be selectively pulsed or placed in a receive mode”, and Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Figs. 2-3, 12-15, and 19-22).
Regarding claim 11, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa further discloses wherein the ultrasound transducer (acoustic device 40, multielement transducer 60) includes a matching layer, wherein the matching layer includes the active surface (see, e.g., Col. 10, lines 32-49, “A metal film layer 124 interconnects the electrically conductive traces 84 and the multielement transducer 60. An epoxy or other filler material may provide a smooth physical bridge 126 between the inner wall of the container 64 and the multielement transducer 60. The multielement transducer 60 may have a metalization layer (not shown) on its upper surface to facilitate electrical connection between the multielement transducer 60 and the metal film layer 124. An insulating layer 128 overlies metal film layer 124. The layer 128 may be KAPTON.TM. with the metal film layer 124 formed upon it using known processing techniques. Additionally, the insulating layer 128 may be of a thickness and acoustic impedance such that it serves as an acoustic matching layer. Alternatively, an acoustic matching layer may be provided on top of the insulating layer 128, or the metal film layer 124 may be formed directly upon the multielement transducer 60 in which case the insulating layer 128 serves only as an acoustic matching layer”).
Regarding claim 12, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa further discloses wherein the ultrasound transducer (acoustic device 40, multielement transducer 60) is configured as a two-dimensional imaging phased array assembly, which includes a one-dimensional device (see, e.g., Col. 5, lines 45-51, “the multielement transducer 60 may be a concave elevationally curved array of piezoelements, such that the multielement transducer is focussed in the elevation plane without an acoustic lens. The concave curved array, like the multielement transducer 60 with the lens 72, may be azimuthally focussed using electronic time delays”, and Col. 16, lines 56-61, “Solid state phased-array transducers such as those described herein image in a plane containing the azimuthal direction of the array. More specifically, as shown in FIG. 2, the device shown would image the plane that includes the line 148 and the axis 48 at the particular rotational position shown”, and Disclosed Claim 4, “wherein the transducer comprises a multielement phased array transducer”).
Regarding claim 13, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa further discloses wherein the ultrasound transducer (acoustic device 40, multielement transducer 60) includes a backing layer (ultrasonically attenuative backing material 66), the backing layer (66) having the backing surface (see, e.g., Col. 5, lines 20-24, “FIG. 3 is a side view of the ultrasonic scanhead 28 shown in FIG. 2. The acoustic device 40 has a multielement transducer 60 mounted on a base 62. The base 62 comprises a container 64 that is filled with an ultrasonically attenuative backing material 66”, and Figs. 3 and 12-17), wherein the backing surface includes a plurality of grooves (dicing kerfs 132) in the backing layer (66) (see, e.g., Col. 11, lines 13-39, “FIG. 14 is a perspective view of the acoustic device shown in FIG. 13. The multielement transducer 60 has a number of electrically independent elements 130 separated by dicing kerfs 132 formed by dicing an initially contiguous piezoelectric material. If the metal film layer 124 is formed by directly depositing a metalization layer on the top of the initially contiguous piezoelectric material, the top edge of the container 64, and the filler material 126, then the metal film layer 124 may, as an alternative, be patterned by appropriate dicing after the metalization is deposited. In particular, the surface of the acoustic device 40 may be diced so that each electrically conductive trace 84 on the outer surface of the container 64 is aligned with and electrically connected to only one of the electrically independent elements 130. Although the physical bridge 126 between the inner wall of the container 64 and the multielement transducer 60 is shown in FIG. 14 for clarity, it would not be visible through the metal film layer 124. The dicing kerfs 132, as shown in FIG. 14, extend through the wall of container 64 and are cut to a depth 136. The depth 136 must be great enough to form the electrically independent elements 130. Accordingly, as shown in outline in FIG. 13, the dicing kerfs 132 extend below the depth of the ground electrode 122. In this manner, the acoustic elements 130, along with their electrodes, the metal film layer 124 and the ground electrode 122, are acoustically and electrically isolated from each other, as is required” (emphasis added), and Figs. 13-14).
Regarding claim 15, Sliwa discloses the medical imaging system of claim 14, as set forth above. Sliwa further discloses wherein the controller is further configured to generate a three-dimensional map of a heart (see, e.g., Col. 1, lines 14-39, “The users of medical ultrasound transducer probes, hereinafter referred to as sonographers, can access bodily regions to be imaged via their free hand physical manipulation, rotation, sliding and tilting of the transducer probe. One area in particular where this manipulation is more challenging is transesophageal cardiac imaging. During transesophageal cardiac imaging, the sonographer orients a scanhead at the tip of the transducer probe in the esophagus or stomach of a patient in order to obtain different fields of view of the heart. To obtain the desired views of the heart, the sonographer may have to slide, twist or curl the transducer probe in order to properly position the scanhead, which contains the imaging transducer(s). For this application, it has been found desirable to rotate the transducer contained in the scanhead independently from the scanhead itself. In combination with the ability to slide, twist or curl the scanhead, the ability to independently rotate the transducer(s) while the scanhead is stationary gives the sonographer the ability to obtain an ultrasonic image of any image plane orthogonal to and intersecting the face of the transducer(s) at each location to which the scanhead can be moved. By giving the sonographer the ability to remotely rotationally orient the acoustic device in the scanhead to obtain different image slices of the heart or its valves, for example, patient comfort is increased. Further, the time required for an ultrasonic examination may be reduced”, and Col. 16, lines 36-48, “The remote acoustic imaging system 32 receives real-time rotational and spatial position information so that the spatial positions of image planes can be recorded, or the acquisition of the image planes may be triggered at desired rotational orientations, angles or positions. The magnetic position sensor 146 may also be used to trigger the acquisition of multiple parallel image planes obtained as the scanhead 28 is dragged axially along the esophagus wall with its imaging plane generally perpendicular to the direction of dragging. During use in this mode, the device is not rotated as it is dragged. In these manners, three-dimensional image sets can be directly obtained using a two-dimensional multielement transducer 60”).
Regarding claim 16, Sliwa discloses the medical imaging system of claim 14, as set forth above. Sliwa further discloses wherein the tracking signal further provides orientation of the magnetic tracking sensor assembly (magnetic position sensor 146) and the generated image includes the location and an orientation of the two-dimensional imaging plane (see, e.g., Col. 16, lines 36-48, “The remote acoustic imaging system 32 receives real-time rotational and spatial position information so that the spatial positions of image planes can be recorded, or the acquisition of the image planes may be triggered at desired rotational orientations, angles or positions. The magnetic position sensor 146 may also be used to trigger the acquisition of multiple parallel image planes obtained as the scanhead 28 is dragged axially along the esophagus wall with its imaging plane generally perpendicular to the direction of dragging. During use in this mode, the device is not rotated as it is dragged. In these manners, three-dimensional image sets can be directly obtained using a two-dimensional multielement transducer 60”).
Regarding claim 17, Sliwa discloses the medical imaging device of claim 14, as set forth above. Sliwa further discloses wherein the ultrasound transducer (acoustic device 40, multielement transducer 60) is configured as a two-dimensional imaging phased array assembly having a one-dimensional array device to provide two-dimensional images by steering an acoustic beam across a two-dimensional plane (see, e.g., Col. 5, lines 45-51, “the multielement transducer 60 may be a concave elevationally curved array of piezoelements, such that the multielement transducer is focussed in the elevation plane without an acoustic lens. The concave curved array, like the multielement transducer 60 with the lens 72, may be azimuthally focussed using electronic time delays”, and Col. 16, lines 56-61, “Solid state phased-array transducers such as those described herein image in a plane containing the azimuthal direction of the array. More specifically, as shown in FIG. 2, the device shown would image the plane that includes the line 148 and the axis 48 at the particular rotational position shown”, and Disclosed Claim 4, “wherein the transducer comprises a multielement phased array transducer”).
Regarding claim 19, Sliwa discloses the method of claim 18, as set forth above. Sliwa further discloses wherein the flexible circuit stack (flexible assembly 42 comprising layers of flexible circuitry 41, 43) is disposed on the magnetic tracking sensor assembly (magnetic position sensor 146) (see, e.g., Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Fig. 17).
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.
Claims 6-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa (US Patent No. 5,575,288 A), as applied to claims 1 and 18-19 above, in view of Fruci et al. (US 2018/0042518 A1, with publication date 02/15/2018, hereinafter Fruci).
Regarding claim 6, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa does not specifically disclose wherein the magnetic tracking sensor assembly is disposed within an encapsulant.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein the magnetic tracking sensor assembly is disposed within an encapsulant (see, e.g., Para. [0030], “the position sensor assembly 100 includes a encapsulating element 140 (i.e., a housing) surrounding the base member 104 and the magnetic field field sensors disposed thereon. In embodiments, the encapsulating element 140 can be an epoxy material. Additionally, the position sensor assembly 100 includes conductors 150 for coupling the magnetic field sensors to electrical connection components (not shown) at or near the proximal portion 112 of the base member 104”, and Para. [0039], “The position sensor assembly 600 further includes a plurality of magnetic field sensors 624, 632 and 640 disposed on the base member 604 in the manner described above in connection with other embodiments, an encapsulating element 644 (e.g., an epoxy coating), and a plurality of conductors 650 electrically coupled to the respective magnetic field sensors 624, 632 and 640”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical imaging device of Sliwa by including wherein the magnetic tracking sensor assembly is disposed within an encapsulant, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably house/surround/coat the magnetic sensor assembly and to desirably electrically couple the magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0030] and [0039]).
Regarding claim 7, Sliwa modified by Fruci discloses the medical imaging device of claim 6, as set forth above. Sliwa does not specifically disclose wherein the encapsulant is an epoxy.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein the encapsulant is an epoxy (see, e.g., Para. [0030], “the position sensor assembly 100 includes a encapsulating element 140 (i.e., a housing) surrounding the base member 104 and the magnetic field field sensors disposed thereon. In embodiments, the encapsulating element 140 can be an epoxy material. Additionally, the position sensor assembly 100 includes conductors 150 for coupling the magnetic field sensors to electrical connection components (not shown) at or near the proximal portion 112 of the base member 104”, and Para. [0039], “The position sensor assembly 600 further includes a plurality of magnetic field sensors 624, 632 and 640 disposed on the base member 604 in the manner described above in connection with other embodiments, an encapsulating element 644 (e.g., an epoxy coating), and a plurality of conductors 650 electrically coupled to the respective magnetic field sensors 624, 632 and 640”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical imaging device of Sliwa modified by Fruci by including wherein the encapsulant is an epoxy, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably house/surround/coat the magnetic sensor assembly and to desirably electrically couple the magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0030] and [0039]).
Regarding claim 8, Sliwa discloses the medical imaging device of claim 1, as set forth above. Sliwa does not specifically disclose wherein the magnetic tracking sensor assembly includes one of a plurality of tunneling magneto-resistive sensors and a plurality of inductive sensors.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein the magnetic tracking sensor assembly includes one of a plurality of tunneling magneto-resistive sensors and a plurality of inductive sensors (see, e.g., Para. [0029], “In the various embodiments, the magnetic field sensors of the position sensor assembly 100 can include any magnetic field sensing technologies now known (e.g., anisotropic magneto-resistive (AMR) sensing elements, giant magneto-resistive (GMR) sensing elements, tunneling magneto-resistive (TMR) sensing elements, colossal magneto-resistive (CMR) sensing elements, extraordinary magneto-resistive (EMR) sensing elements, spin Hall sensing elements, and the like), or later developed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical imaging device of Sliwa by including wherein the magnetic tracking sensor assembly includes one of a plurality of tunneling magneto-resistive sensors and a plurality of inductive sensors, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably electrically couple the selected magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0029-0031] and [0039-0040]).
Regarding claim 9, Sliwa modified by Fruci discloses the medical imaging device of claim 8, as set forth above. Sliwa does not specifically disclose wherein pairs of the plurality of inductive sensors each include a longitudinal portion angled toward each other.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein pairs of the plurality of inductive sensors each include a longitudinal portion angled toward each other (see, e.g., Para. [0029], “In the various embodiments, the magnetic field sensors of the position sensor assembly 100 can include any magnetic field sensing technologies now known (e.g., anisotropic magneto-resistive (AMR) sensing elements, giant magneto-resistive (GMR) sensing elements, tunneling magneto-resistive (TMR) sensing elements, colossal magneto-resistive (CMR) sensing elements, extraordinary magneto-resistive (EMR) sensing elements, spin Hall sensing elements, and the like), or later developed”, and Para. [0039], “FIG. 6 is schematic view of a position sensor assembly 600 according to another embodiment. The position sensor assembly 600 is in many respect similar or identical to the position sensor assembly 200 described above, and includes a base member 604 defining a longitudinal axis 608, a proximal portion 612, a distal portion 616 and a twisted intermediate portion 620 therebetween. The position sensor assembly 600 further includes a plurality of magnetic field sensors 624, 632 and 640 disposed on the base member 604 in the manner described above in connection with other embodiments, an encapsulating element 644 (e.g., an epoxy coating), and a plurality of conductors 650 electrically coupled to the respective magnetic field sensors 624, 632 and 640”, and Fig. 6, where the plurality of magnetic field sensors 624, 632 and 640 are shown to be angled toward each other, such that the sensors 624 and 640 are shown to be angled relatively compared to the position of sensor 632 because the base member 604 (in which the sensors 624, 632, 640 are disposed upon) includes a twisted intermediate portion 620 in between the sensors 624, 640 and respectively sensor 632).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical imaging device of Sliwa modified by Fruci by including wherein pairs of the plurality of inductive sensors each include a longitudinal portion angled toward each other, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably electrically couple the selected magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0029-0031] and [0039-0040]).
Regarding claim 10, Sliwa modified by Fruci discloses the medical imaging device of claim 8, as set forth above. Sliwa does not specifically disclose wherein the magnetic tracking sensor assembly includes the plurality of tunneling magneto-resistive sensors electrically coupled to corresponding sensor circuits.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein the magnetic tracking sensor assembly includes the plurality of tunneling magneto-resistive sensors electrically coupled to corresponding sensor circuits (see, e.g., Para. [0029], “In the various embodiments, the magnetic field sensors of the position sensor assembly 100 can include any magnetic field sensing technologies now known (e.g., anisotropic magneto-resistive (AMR) sensing elements, giant magneto-resistive (GMR) sensing elements, tunneling magneto-resistive (TMR) sensing elements, colossal magneto-resistive (CMR) sensing elements, extraordinary magneto-resistive (EMR) sensing elements, spin Hall sensing elements, and the like), or later developed”, and Para. [0030-0031], and Para. [0039-0040], and Disclosed Claim 11, “wherein the base member is a printed circuit board including a plurality of electrical traces operatively coupled to respective ones of the magnetic field sensors”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical imaging device of Sliwa modified by Fruci by including wherein the magnetic tracking sensor assembly includes the plurality of tunneling magneto-resistive sensors electrically coupled to corresponding sensor circuits, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably electrically couple the selected magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0029-0031] and [0039-0040]).
Regarding claim 20, Sliwa discloses the method of claim 19, as set forth above. Sliwa does not specifically disclose wherein the magnetic tracking sensor assembly is encapsulated in an epoxy prior to folding the flexible circuit into the flexible circuit stack.
However, in the same field of endeavor of magnetic tracking of medical devices, Fruci discloses wherein the magnetic tracking sensor assembly is encapsulated in an epoxy prior to folding the flexible circuit into the flexible circuit stack (see, e.g., Para. [0030], “the position sensor assembly 100 includes a encapsulating element 140 (i.e., a housing) surrounding the base member 104 and the magnetic field field sensors disposed thereon. In embodiments, the encapsulating element 140 can be an epoxy material. Additionally, the position sensor assembly 100 includes conductors 150 for coupling the magnetic field sensors to electrical connection components (not shown) at or near the proximal portion 112 of the base member 104”, and Para. [0039], “The position sensor assembly 600 further includes a plurality of magnetic field sensors 624, 632 and 640 disposed on the base member 604 in the manner described above in connection with other embodiments, an encapsulating element 644 (e.g., an epoxy coating), and a plurality of conductors 650 electrically coupled to the respective magnetic field sensors 624, 632 and 640”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sliwa by including wherein the magnetic tracking sensor assembly is encapsulated in an epoxy prior to folding the flexible circuit into the flexible circuit stack, as disclosed by Fruci. One of ordinary skill in the art would have been motivated to make this modification in order to desirably house/surround/coat the magnetic sensor assembly and to desirably electrically couple the magnetic sensor(s) to respective electrical connections/conductors, as recognized by Fruci (see, e.g., Para. [0030] and [0039]).
Response to Arguments
Applicant's arguments, see Remarks filed 12/01/2025, have been fully considered but they are not persuasive.
Regarding Sliwa (US Patent No. 5,575,288 A), Applicant argues that none of the cited passages from Sliwa teaches or suggests perforations, and that there is no disclosure of perforations or any equivalent thereof in Sliwa.
Examiner respectfully disagrees and emphasizes that Sliwa does disclose each and every feature of the independent claims 1, 14, and 18, as set forth above. Specifically, Examiner emphasizes that Sliwa discloses a layered circuit assembly (flexible assembly 42 comprising layers of flexible circuitry 41, 43, and comprising traces 82, 84) (see, e.g., Col. 4, lines 58-62, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein”, and Col. 6, lines 15-18, “At the distal end of the flexible assembly 42, the flex interconnect traces 82 are connected to mating electrically conductive traces 84 on or within the container 64 of the acoustic device 40”) including a flexible circuit (see, e.g., Col. 4, lines 58-62, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein”) having a plurality of sets of longitudinally extending conductive elements (plurality of flex interconnect traces 82) disposed between longitudinally extending perforations (see, e.g., Col. 4, lines 58-67 and Col. 5, lines 1-19, “As shown in FIG. 2, the flexible assembly 42 may be fabricated from two layers of flexible circuitry 41, 43. Typically, one of the layers of the flexible circuitry 41, 43 has a plurality of flex interconnect traces 82, shown in FIG. 3, formed thereon or therein […] The flex interconnect traces 82 may be fabricated using conventional thin-film, thick-film or additive/subtractive plating process techniques while the flexible assembly 42 and carrier band 120 are in a flat state. Typically, the interconnect traces 82 are thin, metallic, fatigue-resistant and lithographically formed interconnects made from gold, copper or alloys thereof. The optimal thickness of the interconnect traces 82 is approximately 5 to 35 microns. The traces 82 preferably have a net compressive stress as formed in the flat state. The net compressive stress insures that for all points along the length of the flex interconnect traces 82 contained in the movable portion of the flexible assembly 42, the flex interconnect traces 82 remain in a compressive state regardless of the position of the movable portion of the flexible assembly 42. The carrier band 120, if laminated to the face of the flexible assembly 42 that is convex on the movable portion of the flexible assembly 42, will also tend to insure the preferred compressive stress states in the flex interconnect traces 82” (emphasis added), and Col. 9, lines 42-46, “FIG. 12 also shows the flexible assembly 42, having flex interconnect traces 82, described above with reference to FIGS. 2 and 3. In the embodiment of FIG. 12, the flex interconnect traces 82 are disposed on one or both (shown) faces of the flexible assembly 42” (emphasis added), and Col. 16, lines 26-31, “The magnetic position sensor 146 may be electrically connected in a manner similar to that of the electrically independent elements 130 of the multielement transducer 60, wherein flex interconnect traces 82 resident on the flexible assembly 42 and electrically conductive traces 84 on the outer surface of the container 64 are utilized”, and Figs. 3, 12, 16-17, and 19-20).
Examiner emphasizes that the plurality of flex interconnect traces 82 as taught by Sliwa are disclosed to be formed thereon or therein one of the layers of the flexible circuitry 41, 43, such that the flex interconnect traces 82 may be fabricated using additive/subtractive plating process techniques while the flexible assembly 42 and carrier band 120 are in a flat state. Examiner’s interpretation is that the plurality of flex interconnect traces 82 can be formed thereon or therein the flexible circuitry 41, 43 using an additive or subtractive plating process, and therefore, after the plurality of flex interconnect traces 82 are formed/fabricated, there would inherently be a space/gap/section/perforation/etc. on the flexible circuitry 41, 43 in portions that are in between each of the plurality of flex interconnect traces 82 formed/fabricated thereon or therein the flexible circuitry 41, 43. Examiner notes that the spacing/gap/section/perforation/etc on the flexible circuitry 41, 43 in portions that are in between each of the plurality of flex interconnect traces 82 formed/fabricated thereon or therein the flexible circuitry 41, 43 can be further visualized in Figs. 3 and 12 of Sliwa. Therefore, Sliwa does disclose each and every feature of the independent claims 1, 14, and 18, as set forth above.
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798