DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments under 37 CFR 1.132 filed 11/07/2025 is sufficient to overcome the rejection of claims 21-40 based upon the current rejection failing to teach all aspects of the amended claims.
Claims 23, 24, 27, and 28 have been cancelled. Newly added claims 41-44 are acknowledged. Claims 21, 22, 25, 26, 29-44 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/07/2025, with respect to the rejection(s) of claim(s) 21-40 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for Claim(s) 21-22, 26, 29-34, and 36-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschenman (US 9179971 B2) in view of Govari (US 20180228392 A1), further in view of Govari (2) (US 20180180684 A1) and Beaver (US 3504276 A); Claim(s) 25 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschenman (US 9179971 B2) in view of in view of Govari (1) (US 20180228392 A1), further in view of Govari (2) (US 20180180684 A1) and Beaver (US 3504276 A), further in view of Byrd (US 20160317094 A1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 21-22, 26, 29-34, and 36-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschenman (US 9179971 B2) in view of Govari (US 20180228392 A1), further in view of Govari (2) (US 20180180684 A1) and Beaver (US 3504276 A).
Regrading claim 21, Kirschenman teaches an apparatus, comprising: a body (Fig 2B; catheter 24); and a shaft assembly extending distally from the body (Fig 2B; shaft body portion 26), the shaft assembly comprising: a proximal portion defining a longitudinal axis (Fig 2B; proximal portion 30), a steerable portion distal to the proximal portion (Fig 2B; [33] The handle 164 may provide a location for the clinician to hold the catheter 24 and may further provide means for steering or guiding the shaft body 26 within the body of a patient), a distal portion distal to the steerable portion (Fig 2B; distal end portion 28), the steerable portion being operable to drive the distal portion laterally away from and toward the longitudinal axis ([35] The combination of the deflection mechanism 170 and the pull assembly provides a means by which a user or physician can effect movement (e.g., deflection) of the distal end portion 28 in one or more directions, and therefore, allows the physician to steer the catheter 24), at least one flex circuit assembly ([30] it may be desirable for the traces 36 to be more flexible to bend as the body 26 bends) ([44] A plurality of force sensor junctions 82 may effectively form an electrical circuit similar to that shown in FIG. 6) wrapped around the proximal portion, the steerable portion, or the distal portion (Fig 2B; proximal portion 30) (Fig 2B; distal end portion 28) ([47] the ring electrodes 90 and traces 92 have been printed on a first layer 96 of the catheter body 88). Kirschenman fails to teach the at least one flex circuit assembly comprising: a flexible substrate comprising an outer face, the outer face of the flexible substrate facing outwardly from the shaft assembly when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, at least two first coil portions positioned on the outer face of the flexible substrate, the at least two first coil portions together forming a first navigation sensor, and the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other, at least three second coil portions positioned on the inner face of the flexible substrate, such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least three second coil portions are positioned angularly offset from the at least two first coil portions, the at least three second coil portion forming a second navigation sensor.
However, Govari teaches at least one flex circuit assembly ([0025] the substrate comprises a flexible circuit board 52), the at least one flex circuit assembly comprising: a flexible substrate comprising an outer face ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board) and an inner face ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52), the outer face of the flexible substrate facing outwardly from the shaft assembly when the flex circuit assembly is wrapped around the proximal portion , the steerable portion, or the distal portion of the shaft assembly ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board) , at least one first coil portion positioned on the outer face of the flexible substrate ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board), the at least two first coil portion forming a first navigation sensor ([0019] one or more position sensors 50 shown in an inset 23) ([0021] Distal-end assembly 40 typically comprises one or more position sensors 50 and, for example, one or more mapping electrodes (not shown)) ([0037] sensor 50 may comprise any suitable number of coils, having any suitable shape and arranged so that board 52 may be folded into any suitable shape, thereby arranging the axes of the coils at any angle that is not parallel with one another), the at least two first coil portions positioned on the outer face of the flexible substrate ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board) at least three second coil portion positioned on the inner face of the flexible substrate ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52) ([0037] sensor 50 may comprise any suitable number of coils, having any suitable shape and arranged so that board 52 may be folded into any suitable shape, thereby arranging the axes of the coils at any angle that is not parallel with one another), the at least three second coil portion being angularly offset from the at least one first coil portion ([0028] As can be seen in FIG. 2A above, coils 54 and 56 are formed with a certain offset relative to one another on board 52. The offset is calculated so that, after board 52 is rolled to the cylindrical shape, the two coils will be oriented with mutually-orthogonal axes), the at least three second coil portion forming a second navigation sensor ([0019] one or more position sensors 50 shown in an inset 23) ([0037] sensor 50 may comprise any suitable number of coils, having any suitable shape and arranged so that board 52 may be folded into any suitable shape, thereby arranging the axes of the coils at any angle that is not parallel with one another). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the at least one flex circuit assembly comprising: a flexible substrate comprising an outer face, the outer face of the flexible substrate facing outwardly from the shaft assembly when the flex circuit assembly is wrapped around the proximal portion , the steerable portion, or the distal portion of the shaft assembly, at least one first coil portion positioned on the outer face of the flexible substrate, the at least one first coil portion forming a first navigation sensor, the at least two first coil portions positioned on the outer face of the flexible substrate, at least one second coil portion positioned on the inner face of the flexible substrate, the at least one second coil portion being angularly offset from the at least one first coil portion, the at least one second coil portion forming a second navigation sensor. Doing so enhances the magnetic field and sensing all around the device. Obvious statement about number of coils Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to alter the number of coils, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Further, Govari (2) teaches the at least two first coil portions ([0083] Sensor 24 comprises a plurality of coils) ([0090] A first set 90 of conducting elements comprises a first plurality of spiral conductors 92. By way of example, FIG. 2A illustrates four spiral conductors, identified as spiral conductors 92A, 92B, 92C, 92D) positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other ([0092] As stated above the spirals of set 90 are positioned along a line segment parallel to the x-axis. Furthermore, the spirals are separated from each other along the line segment, and the separations are such that when sheet 80 is rolled about itself, around an axis 150 parallel to the y-axis that is herein also termed the sensor axis, the spirals of set 90 align with themselves, as is illustrated schematically in FIG. 3) ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the axis). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other. Doing so allows for a balanced output around the device.
Furthermore, Beaver teaches and the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other ([52] Now turning to FIG. 2, a nonconductive printed- circuit type board 20 having a wide surface contour which is curvilinear, such as with board 3 described above, has a multiturn coil 25 affixed in conventional manner to one surface of the board and a similar multiturn coil 27 affixed to the other surface of the board and diametrically oppositely disposed), at least three second coil portions positioned on the inner face of the flexible substrate (Fig 12; [75] On one side of the board are coils 90, 91 and 92, and respectively opposite each of the coils are coils 93, 94 and 95, appropriately interconnected through the board by connectors 96, 97 and 98). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other, at least three second coil portions positioned on the inner face of the flexible substrate. Doing so allows for the maximum number of coils placed in a confined space, and thereby maximizing the signal voltage (Beaver [27]).
Regarding claim 22, Kirschenman teaches the apparatus of claim 21, but fails to teach wherein the at least one second coil portion forming the second navigation sensor on the inner face of the flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the at least one first coil portion forming the first navigation sensor on the outer face of the flexible substrate. However, Govari teaches wherein the at least one second coil portion forming the second navigation sensor on the inner face of the flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the at least one first coil portion forming the first navigation sensor on the outer face of the flexible substrate ([0012] A position sensor may comprise multiple (e.g., three) coils arranged orthogonally to, and concentric with, one another). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein the at least one second coil portion forming the second navigation sensor on the inner face of the flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the at least one first coil portion forming the first navigation sensor on the outer face of the flexible substrate. Doing so enhances the magnetic field and sensing all around the device.
Regarding claim 29, Kirschenman teaches the apparatus of claim 21, but fails to teach wherein the at least one flex circuit assembly is configured as a double-axis sensor assembly such that the first navigation sensor on the outer face of the flexible substrate provides a first sensor axis, and the second navigation sensor on the inner face of the flexible substrate provides a second sensor axis. However, Govari teaches wherein the at least one flex circuit assembly is configured as a double-axis sensor assembly ([0036] by forming board 52 into a cylindrical shape, sensor 50 becomes a dual-axis sensor) such that the first navigation sensor on the outer face of the flexible substrate provides a first sensor axis, and the second navigation sensor on the inner face of the flexible substrate provides a second sensor axis ([0005] such that in the 3D shape the first and second field-sensing coils have first and second respective axes that are not parallel to one another). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein the at least one flex circuit assembly is configured as a double-axis sensor assembly such that the first navigation sensor on the outer face of the flexible substrate provides a first sensor axis, and the second navigation sensor on the inner face of the flexible substrate provides a second sensor axis. Doing so enhances the magnetic field and sensing all around the device.
Regarding claim 26, Kirschenman teaches the apparatus of claim 21, but fails to teach wherein the flex circuit assembly further comprises: at least one first connection pad on the inner face of the flexible substrate, the at least one first connection pad configured to provide electrical connection of the at least two first coil portions; and at least one second connection pad on the inner face of the flexible substrate, the at least one second connection pad configured to provide electrical connection of the at least one second coil portion.
However, Govari (2) teaches wherein the flex circuit assembly further comprises: at least one first connection pad on the inner face of the flexible substrate (Fig 2A; conducting side 84), the at least one first connection pad configured to provide electrical connection of the at least one first coil portion ([0095] FIG. 4A is a schematic cross-section of sensor 24, taken in a plane orthogonal to sensor axis 150, and FIG. 4B is a schematic cross-section of set 90 of the sensor, taken in a plane parallel to axis 150. FIGS. 4A and 4B illustrate the positioning of vias 130 and 132 as they interconnect spirals 92A, 92B, 92C, and 92D); and at least one second connection pad on the inner face of the flexible substrate, the at least one second connection pad configured to provide electrical connection of the at least one second coil portion ([0097] The spirals of set 94 are also positioned along a line segment parallel to the x-axis, and the spirals have substantially the same separations on the line segment as the spirals of set 90).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein the flex circuit assembly further comprises: at least one first connection pad on the inner face of the flexible substrate, the at least one first connection pad configured to provide electrical connection of the at least one first coil portion; and at least one second connection pad on the inner face of the flexible substrate, the at least one second connection pad configured to provide electrical connection of the at least one second coil portion. Doing so would electrically connect the coils and enhanced sensing capability.
Regarding claim 30, Kirschenman teaches the apparatus of claim 29, but fails to teach wherein the first navigation sensor on the outer face of the flexible substrate is independent of the second navigation sensor on the inner face of the flexible substrate. However, Govari teaches wherein the first navigation sensor on the outer face of the flexible substrate is independent of the second navigation sensor on the inner face of the flexible substrate ([0006] the first and second layers are electrically isolated from one another). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein the first navigation sensor on the outer face of the flexible substrate is independent of the second navigation sensor on the inner face of the flexible substrate. Doing so allows for multiple sensors that can differ from each other in their sensing abilities.
Regarding claim 31, Kirschenman teaches an apparatus, comprising: a body (Fig 2B; catheter 24); and a shaft assembly extending distally from the body (Fig 2B; shaft body portion 26), the shaft assembly comprising: a proximal portion defining a longitudinal axis (Fig 2B; proximal portion 30), a steerable portion distal to the proximal portion (Fig 2B; [33] The handle 164 may provide a location for the clinician to hold the catheter 24 and may further provide means for steering or guiding the shaft body 26 within the body of a patient), a distal portion distal to the steerable portion (Fig 2B; distal end portion 28), the steerable portion being operable to drive the distal portion laterally away from and toward the longitudinal axis ([35] The combination of the deflection mechanism 170 and the pull assembly provides a means by which a user or physician can effect movement (e.g., deflection) of the distal end portion 28 in one or more directions, and therefore, allows the physician to steer the catheter 24), a distal flex circuit assembly wrapped around the distal portion or the steerable portion of the shaft assembly ([30] it may be desirable for the traces 36 to be more flexible to bend as the body 26 bends) ([44] A plurality of force sensor junctions 82 may effectively form an electrical circuit similar to that shown in FIG. 6) (Fig 2B; proximal portion 30) (Fig 2B; distal end portion 28) ([47] the ring electrodes 90 and traces 92 have been printed on a first layer 96 of the catheter body 88), a proximal flex circuit assembly wrapped around the proximal portion or the steerable portion of the shaft assembly (Fig 2B; proximal portion 30) (Fig 2B; distal end portion 28) ([47] the ring electrodes 90 and traces 92 have been printed on a first layer 96 of the catheter body 88). Kirschenman fails to teach the distal flex circuit assembly comprising: a distal flexible substrate comprising a distal outer face, and a distal inner face, the distal outer face of the distal flexible substrate facing outwardly from the shaft assembly when the distal flex circuit assembly is wrapped around the steerable portion or the distal portion of the shaft assembly, at least one first distal coil portion positioned on the distal outer face of the flexible substrate, the at least one first distal coil portion forming a first distal navigation sensor, and at least one second distal coil portion positioned on the distal inner face of the flexible substrate, the at least one second distal coil portion being angularly offset from the at least one first distal coil portion, the at least one second distal coil portion forming a second distal navigation sensor, the distal flex circuit assembly comprising: a proximal flexible substrate comprising a proximal outer face, and a proximal inner face, the proximal outer face of the proximal flexible substrate facing outwardly from the shaft assembly when the proximal flex circuit assembly is wrapped around the steerable portion or the proximal portion of the shaft assembly, at least one first proximal coil portion positioned on the proximal outer face of the flexible substrate, the at least one first proximal coil portion forming a first proximal navigation sensor, and at least one second proximal coil portion positioned on the proximal inner face of the flexible substrate, the at least one second proximal coil portion being angularly offset from the at least one first proximal coil portion, the at least one second proximal coil portion forming a second proximal navigation sensor.
However, Govari teaches the distal flex circuit assembly comprising: a distal flexible substrate comprising a distal outer face ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board) and a distal inner face ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52), the distal outer face of the distal flexible substrate facing outwardly from the shaft assembly when the distal flex circuit assembly is wrapped around the steerable portion or the distal portion of the shaft assembly ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board), at least one first distal coil portion positioned on the distal outer face of the flexible substrate, the at least two first distal coil portion forming a first distal navigation sensor ([0019] one or more position sensors 50 shown in an inset 23) ([0021] Distal-end assembly 40 typically comprises one or more position sensors 50 and, for example, one or more mapping electrodes (not shown)) ([0037] sensor 50 may comprise any suitable number of coils, having any suitable shape and arranged so that board 52 may be folded into any suitable shape, thereby arranging the axes of the coils at any angle that is not parallel with one another), and at least two second distal coil portion positioned on the distal inner face of the flexible substrate ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board), the at least three second distal coil portion being angularly offset from the at least one first distal coil portion ([0028] As can be seen in FIG. 2A above, coils 54 and 56 are formed with a certain offset relative to one another on board 52. The offset is calculated so that, after board 52 is rolled to the cylindrical shape, the two coils will be oriented with mutually-orthogonal axes), the at least three second distal coil portion forming a second distal navigation sensor ([0019] one or more position sensors 50 shown in an inset 23) ([0037] sensor 50 may comprise any suitable number of coils, having any suitable shape and arranged so that board 52 may be folded into any suitable shape, thereby arranging the axes of the coils at any angle that is not parallel with one another); the distal flex circuit assembly comprising: a proximal flexible substrate comprising a proximal outer face ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board) and a proximal inner face ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52), the proximal outer face of the proximal flexible substrate facing outwardly from the shaft assembly when the proximal flex circuit assembly is wrapped around the steerable portion or the proximal portion of the shaft assembly, at least one first proximal coil portion positioned on the proximal outer face of the flexible substrate ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board), the at least one first proximal coil portion forming a first proximal navigation sensor ([0019] one or more position sensors 50 shown in an inset 23) ([0021] Distal-end assembly 40 typically comprises one or more position sensors 50 and, for example, one or more mapping electrodes (not shown)), and at least one second proximal coil portion positioned on the proximal inner face of the flexible substrate ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52), the at least one second proximal coil portion being angularly offset from the at least one first proximal coil portion ([0028] As can be seen in FIG. 2A above, coils 54 and 56 are formed with a certain offset relative to one another on board 52. The offset is calculated so that, after board 52 is rolled to the cylindrical shape, the two coils will be oriented with mutually-orthogonal axes), the at least one second proximal coil portion forming a second proximal navigation sensor ([0019] one or more position sensors 50 shown in an inset 23). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the distal flex circuit assembly comprising: a distal flexible substrate comprising a distal outer face, and a distal inner face, the distal outer face of the distal flexible substrate facing outwardly from the shaft assembly when the distal flex circuit assembly is wrapped around the steerable portion or the distal portion of the shaft assembly, at least one first distal coil portion positioned on the distal outer face of the flexible substrate, the at least one first distal coil portion forming a first distal navigation sensor, and at least one second distal coil portion positioned on the distal inner face of the flexible substrate, the at least one second distal coil portion being angularly offset from the at least one first distal coil portion, the at least one second distal coil portion forming a second distal navigation sensor, the distal flex circuit assembly comprising: a proximal flexible substrate comprising a proximal outer face, and a proximal inner face, the proximal outer face of the proximal flexible substrate facing outwardly from the shaft assembly when the proximal flex circuit assembly is wrapped around the steerable portion or the proximal portion of the shaft assembly, at least one first proximal coil portion positioned on the proximal outer face of the flexible substrate, the at least one first proximal coil portion forming a first proximal navigation sensor, and at least one second proximal coil portion positioned on the proximal inner face of the flexible substrate, the at least one second proximal coil portion being angularly offset from the at least one first proximal coil portion, the at least one second proximal coil portion forming a second proximal navigation sensor. Doing so allows for multiple sensors that can differ from each other in their sensing abilities. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to alter the number of coils, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Further, Govari (2) teaches the at least two first coil portions ([0083] Sensor 24 comprises a plurality of coils) ([0090] A first set 90 of conducting elements comprises a first plurality of spiral conductors 92. By way of example, FIG. 2A illustrates four spiral conductors, identified as spiral conductors 92A, 92B, 92C, 92D) positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other ([0092] As stated above the spirals of set 90 are positioned along a line segment parallel to the x-axis. Furthermore, the spirals are separated from each other along the line segment, and the separations are such that when sheet 80 is rolled about itself, around an axis 150 parallel to the y-axis that is herein also termed the sensor axis, the spirals of set 90 align with themselves, as is illustrated schematically in FIG. 3) ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the axis). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other. Doing so allows for a balanced output around the device.
Furthermore, Beaver teaches and the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other ([52] Now turning to FIG. 2, a nonconductive printed- circuit type board 20 having a wide surface contour which is curvilinear, such as with board 3 described above, has a multiturn coil 25 affixed in conventional manner to one surface of the board and a similar multiturn coil 27 affixed to the other surface of the board and diametrically oppositely disposed), at least three second coil portions positioned on the inner face of the flexible substrate (Fig 12; [75] On one side of the board are coils 90, 91 and 92, and respectively opposite each of the coils are coils 93, 94 and 95, appropriately interconnected through the board by connectors 96, 97 and 98). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the at least two first coil portions positioned on the outer face of the flexible substrate such that when the flex circuit assembly is wrapped around the proximal portion, the steerable portion, or the distal portion of the shaft assembly, the at least two first coil portions are positioned generally diametrically opposed to each other, at least three second coil portions positioned on the inner face of the flexible substrate. Doing so allows for the maximum number of coils placed in a confined space, and thereby maximizing the signal voltage (Beaver [27]).
Regarding claim 32, Kirschenman teaches the apparatus of claim 31, but fails to teach wherein: the second distal navigation sensor on the distal inner face of the distal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first distal navigation sensor on the distal outer face of the distal flexible substrate; and/or the second proximal navigation sensor on the proximal inner face of the proximal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first proximal navigation sensor on the proximal outer face of the proximal flexible substrate. However, Govari teaches wherein: the second distal navigation sensor on the distal inner face of the distal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first distal navigation sensor on the distal outer face of the distal flexible substrate ([0012] A position sensor may comprise multiple (e.g., three) coils arranged orthogonally to, and concentric with, one another); and/or the second proximal navigation sensor on the proximal inner face of the proximal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first proximal navigation sensor on the proximal outer face of the proximal flexible substrate ([0012] A position sensor may comprise multiple (e.g., three) coils arranged orthogonally to, and concentric with, one another). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein: the second distal navigation sensor on the distal inner face of the distal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first distal navigation sensor on the distal outer face of the distal flexible substrate; and/or the second proximal navigation sensor on the proximal inner face of the proximal flexible substrate is angularly offset by about 90 degrees about a circumference of the shaft assembly from the first proximal navigation sensor on the proximal outer face of the proximal flexible substrate. Doing so enhances the range and sensing all around the device.
Regarding claim 33, Kirschenman teaches the apparatus of claim 31, but fails to teach, wherein: the at least one first proximal coil portion comprises at least two first proximal coil portions, and the at least two first proximal coil portions, such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the at least two first proximal coil portions are positioned generally diametrically opposed to each other.
However, Govari (1) teaches coils are positioned on the proximal outer face of the proximal flexible substrate ([0026] and coil 58 is formed on the lower surface of board 52, which is the external surface of board 52 that faces the tissue after rolling the board).
Further, Govari (2) teaches wherein: the at least one first proximal coil portion comprises at least two first proximal coil portions, and the at least two first proximal coil portions ([0083] Sensor 24 comprises a plurality of coils) ([0090] A first set 90 of conducting elements comprises a first plurality of spiral conductors 92. By way of example, FIG. 2A illustrates four spiral conductors, identified as spiral conductors 92A, 92B, 92C, 92D), such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the at least two first proximal coil portions are positioned generally diametrically opposed to each other ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the axis).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein: the at least one first proximal coil portion comprises at least two first proximal coil portions, and the at least two first proximal coil portions, such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the at least two first proximal coil portions are positioned generally diametrically opposed to each other. Doing so enhances the range and sensing all around the device.
Regarding claim 34, Kirschenman teaches the apparatus of claim 33, but fails to teach wherein: the at least two first proximal coil portions are electrically coupled to each other such that they collectively form the first proximal navigation sensor.
However, Govari (2) teaches wherein: the at least two first proximal coil portions are electrically coupled to each other such that they collectively form the first proximal navigation sensor ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the axis). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein: the at least two first proximal coil portions are electrically coupled to each other such that they collectively form the first proximal navigation sensor. Doing so would electrically connect the coils and result in enhanced sensing capability.
Regarding claim 36, Kirschenman teaches the apparatus of claim 31, but fails to teach wherein: the distal flex circuit assembly further comprises: at least one first distal connection pad on the distal inner face of the distal flexible substrate, the at least one first distal connection pad configured to provide electrical connection of the at least two first distal coil portion, and at least one second distal connection pad on the distal inner face of the distal flexible substrate, the at least one second distal connection pad configured to provide electrical connection of the at least three second distal coil portion; and/or the proximal flex circuit assembly further comprises: at least one first proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one first proximal connection pad configured to provide electrical connection of the at least one first proximal coil portion, and at least one second proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one second proximal connection pad configured to provide electrical connection of the at least one second proximal coil portion.
However, Govari (2) teaches wherein: the distal flex circuit assembly further comprises: at least one first distal connection pad on the distal inner face of the distal flexible substrate (Fig 2A; conducting side 84), the at least one first distal connection pad configured to provide electrical connection of the at least one first distal coil portion ([0095] FIG. 4A is a schematic cross-section of sensor 24, taken in a plane orthogonal to sensor axis 150, and FIG. 4B is a schematic cross-section of set 90 of the sensor, taken in a plane parallel to axis 150. FIGS. 4A and 4B illustrate the positioning of vias 130 and 132 as they interconnect spirals 92A, 92B, 92C, and 92D), and at least one second distal connection pad on the distal inner face of the distal flexible substrate, the at least one second distal connection pad configured to provide electrical connection of the at least one second distal coil portion ([0097] The spirals of set 94 are also positioned along a line segment parallel to the x-axis, and the spirals have substantially the same separations on the line segment as the spirals of set 90); and/or the proximal flex circuit assembly further comprises: at least one first proximal connection pad on the proximal inner face of the proximal flexible substrate (Fig 2A; conducting side 84), the at least one first proximal connection pad configured to provide electrical connection of the at least one first proximal coil portion ([0095] FIG. 4A is a schematic cross-section of sensor 24, taken in a plane orthogonal to sensor axis 150, and FIG. 4B is a schematic cross-section of set 90 of the sensor, taken in a plane parallel to axis 150. FIGS. 4A and 4B illustrate the positioning of vias 130 and 132 as they interconnect spirals 92A, 92B, 92C, and 92D), and at least one second proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one second proximal connection pad configured to provide electrical connection of the at least one second proximal coil portion ([0097] The spirals of set 94 are also positioned along a line segment parallel to the x-axis, and the spirals have substantially the same separations on the line segment as the spirals of set 90). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein: the distal flex circuit assembly further comprises: at least one first distal connection pad on the distal inner face of the distal flexible substrate, the at least one first distal connection pad configured to provide electrical connection of the at least one first distal coil portion, and at least one second distal connection pad on the distal inner face of the distal flexible substrate, the at least one second distal connection pad configured to provide electrical connection of the at least one second distal coil portion; and/or the proximal flex circuit assembly further comprises: at least one first proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one first proximal connection pad configured to provide electrical connection of the at least one first proximal coil portion, and at least one second proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one second proximal connection pad configured to provide electrical connection of the at least one second proximal coil portion. Doing so would electrically connect the coils and result in enhanced sensing capability.
Further, Beaver teaches and/or the proximal flex circuit assembly further comprises: at least one first proximal connection pad on the proximal inner face of the proximal flexible substrate (Fig 2; [52] Innermost coil ends 31 and 35 are connected through board 20 by a connector 37), the at least one first proximal connection pad configured to provide electrical connection of the at least one first proximal coil portion(Fig 2; [52] Innermost coil ends 31 and 35 are connected through board 20 by a connector 37), and at least one second proximal connection pad on the proximal inner face of the proximal flexible substrate (Fig 2; [52] Innermost coil ends 31 and 35 are connected through board 20 by a connector 37), the at least one second proximal connection pad configured to provide electrical connection of the at least one second proximal coil portion (Fig 2; [52] Innermost coil ends 31 and 35 are connected through board 20 by a connector 37). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include the proximal flex circuit assembly further comprises: at least one first proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one first proximal connection pad configured to provide electrical connection of the at least one first proximal coil portion, and at least one second proximal connection pad on the proximal inner face of the proximal flexible substrate, the at least one second proximal connection pad configured to provide electrical connection of the at least one second proximal coil portion. Doing so allows the connection to be made through the substrate to the coils on the other side.
Regarding claim 37, Kirschenman teaches the apparatus of claim 31, but fails to teach wherein: the at least one second proximal coil portion comprises three second proximal coil portions, the three second proximal coil portions being positioned on the proximal inner face of the proximal flexible substrate, such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the three second proximal coil portions are positioned angularly offset from the at least one first proximal coil portion on the proximal outer surface.
However, Govari (1) teaches the three second proximal coil portions being positioned on the proximal inner face of the proximal flexible substrate ([0026] As shown in the sectional view of FIG. 2A, coil 54 is formed on the upper surface of board 52, coil 56 is embedded within an internal layer of board 52).
Further, Govari (2) teaches wherein: the at least one second proximal coil portion comprises three second proximal coil portions ([0109] sensor 224 which has three coils that are orthogonal to each other) ([0083] Sensor 24 comprises a plurality of coils) ([0090] A first set 90 of conducting elements comprises a first plurality of spiral conductors 92. By way of example, FIG. 2A illustrates four spiral conductors, identified as spiral conductors 92A, 92B, 92C, 92D), such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the three second proximal coil portions are positioned angularly offset from the at least one first proximal coil portion on the proximal outer surface ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the axis).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Kirschenman to include wherein: the at least one second proximal coil portion comprises three second proximal coil portions, the three second proximal coil portions being positioned on the proximal inner face of the proximal flexible substrate, such that when the proximal flex circuit assembly is wrapped around the proximal portion or the steerable portion of the shaft assembly, the three second proximal coil portions are positioned angularly offset from the at least one first proximal coil portion on the proximal outer surface. Doing so enhances the range and sensing all around the device.
Regarding claim 38, Kirschenman teaches the apparatus of claim 37, but fails to teach wherein: the three second proximal coil portions are electrically coupled to each other such that they collectively form the second proximal navigation sensor.
However, Govari (2) teaches wherein: the three second proximal coil portions are electrically coupled to each other such that they collectively form the second proximal navigation sensor ([0109] In sensor 324 each of a pair of conducting coils 94B1, 94B2 is generally similar to set 94A, the pair having a common axis of symmetry orthogonal to, and intersecting, sensor axis 150, and being separated along the