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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18-37 are rejected under 35 U.S.C. 103 as being unpatentable over Silwa (U.S. Patent No. 11,179,194 B2).
With respect to claim 18, Silwa discloses a method of modifying contact status of one or more electrodes in a plurality of electrodes located on a medical device (cathether 16 including electrodes 42, 44, 46, 48 and 50 shown in Fig. 1), the method comprising:
measuring an electrical characteristic of each electrode in the plurality of
electrodes (see element 90 shown in Fig. 9, measure electrical characteristic associated with coil 44, 46 or 48); determining a contact status for each electrode based on the measured electrical
characteristic, wherein the contact status is selected from a plurality of
possible contact statuses (the field generated by the current in coil 44, 46, or 48 is intended to at least partially cancel the magnetic field generated by the current in coil 50. Even in the absence of a contact force on distal end 40 of catheter 16, generating a current in coil 50 and creation of the resulting magnetic field will induce a current in coils 44, 46, 48. Simultaneously, generating an opposing magnetic field by applying a current to one or more of coils 44, 46, 48 results in a smaller summed net electromagnetic field); and
modifying the contact status of a first electrode in the plurality of electrodes based
at least in part on a determined contact status of one or more other
electrodes in the plurality of electrodes (a means for measuring contact force between catheter 16 and tissue 12 in body 14 that is less complex and less expensive than conventional systems. In particular, the use of series connected coils 44, 46, 48, 50 in FIGS. 6 and 8 and/or coils connected at one end in FIG. 7 enables a contact force to be determined while reducing the number of conductors 80 needed within catheter 16 col. 18, line 64-col. 19, line 5).
With respect to claim 19, Silwa discloses the method of claim 18, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and distance of the one or more other electrodes to the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 20, Silwa discloses the method of claim 19, wherein the determined contact status of the one
or more other electrodes located closer to the first electrode are given greater weight than
the determined contact status of the one or more other electrodes located further from the
first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 21, Silwa discloses the method of claim 18, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and contact status history of the first electrode (cathether 16 including electrodes 42, 44, 46, 48 and 50 shown in Fig. 1).
With respect to claim 22, Silwa discloses the method of claim 18, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and contact status history of the one or more other electrodes (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 23, Silwa discloses the method of claim 18, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes, distance of the one or more other electrodes to the first electrode, and contact status history of the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 24, Silwa discloses the method of claim 23, wherein the determined contact status of the one or more other electrodes located closer to the first electrode are given greater weight than the determined contact status of the one or more other electrodes located further from the first electrode (determining a contact force between the distal portion 70 of shaft 36 and tissue 12 responsive to the determined positions of coils 44, 46, 48, 50. Process 104 may be implemented in a variety of ways. In accordance with one embodiment, process 104 may implement the subprocess 106 of adjusting the first position of coil 50 (determined with reference to fields created by external generator 22) responsive to the second position of coil 50 (determined with reference to fields created within catheter 16) col. 18, line 64-col. 19, line 5).
With respect to claim 25, Silwa discloses the method of claim 18, wherein measuring the electrical characteristic includes measuring an impedance value (receive a plurality of input signals including signals generated by ablation generator 18, electrodes 42 and coils 44, 46, 48, 50 on catheter 16, and RCGS 20 and generate a plurality of output signals including those used to control and/or provide data to electrode 42 and coils 44, 46, 48, 50 on catheter 16, ablation generator 18, RCGS 20, field generator 22 and display system 24).
Witih respect to claim 26, Silwa discloses the method of claim 18, wherein the contact status comprises a 'no contact' state, an 'intermittent contact' state, and a "contact" state (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 27, Silwa discloses a system for use with a medical device having a plurality of electrodes and
configured for insertion within a patient, the system comprising:
a signal generator configured to apply a plurality of drive signals to the plurality
of electrodes (the field generated by the current in coil 44, 46, or 48 is intended to at least partially cancel the magnetic field generated by the current in coil 50. Even in the absence of a contact force on distal end 40 of catheter 16, generating a current in coil 50 and creation of the resulting magnetic field will induce a current in coils 44, 46, 48. Simultaneously, generating an opposing magnetic field by applying a current to one or more of coils 44, 46, 48 results in a smaller summed net electromagnetic field); a measurement circuit configured to measure responses of the plurality of
electrodes to the drive signals and generate an impedance value for each of
the plurality of electrodes of the medical device (see element 90 shown in Fig. 9, measure electrical characteristic associated with coil 44, 46 or 48); and
a contact assessment module configured to, for each electrode, determine a
contact status from a plurality of possible contact statuses of each of the
plurality of electrodes with adjacent tissue based on the generated
impedance value associated with each electrode and modify the contact
status of a first electrode based, at least in part, on the contact status of one
or more of the other electrodes (a means for measuring contact force between catheter 16 and tissue 12 in body 14 that is less complex and less expensive than conventional systems. In particular, the use of series connected coils 44, 46, 48, 50 in FIGS. 6 and 8 and/or coils connected at one end in FIG. 7 enables a contact force to be determined while reducing the number of conductors 80 needed within catheter 16 col. 18, line 64-col. 19, line 5).
With respect to claim 28, Silwa discloses the system of claim 27, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and distance of the one or more other electrodes to the first electrode (the field generated by the current in coil 44, 46, or 48 is intended to at least partially cancel the magnetic field generated by the current in coil 50. Even in the absence of a contact force on distal end 40 of catheter 16, generating a current in coil 50 and creation of the resulting magnetic field will induce a current in coils 44, 46, 48. Simultaneously, generating an opposing magnetic field by applying a current to one or more of coils 44, 46, 48 results in a smaller summed net electromagnetic field).
With respect to claim 29, Silwa discloses the system of claim 28, wherein the determined contact status of the one or more other electrodes located closer to the first electrode are given greater weight than the determined contact status of the one or more other electrodes located further
from the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 30, Silwa discloses the system of claim 27, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and contact status history of the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 31, Silwa discloses the system of claim 27, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes and contact status history of the one or more other electrodes (cathether 16 including electrodes 42, 44, 46, 48 and 50 shown in Fig. 1).
With respect to claim 32, Silwa discloses the system of claim 27, wherein modifying the contact status of the first electrode is based on a combination of determined contact status of the one or more other electrodes, distance of the one or more other electrodes to the first electrode, and
contact status history of the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 33, Silwa discloses the system of claim 32, wherein the determined contact status of the one or more other electrodes located closer to the first electrode are given greater weight than the determined contact status of the one or more other electrodes located further
from the first electrode (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
With respect to claim 34, Silwa discloses a method of determining contact status of one or more electrodes in a plurality of electrodes located on a medical device, the method comprising:
measuring an electrical characteristic of each electrode in the plurality of
electrodes (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48); and determining a contact status for a first electrode based on a combination of the
measured electrical characteristic, contact status of one or more other
electrodes in the plurality of electrodes, and distance between the first
electrode and the one or more other electrodes in the plurality of
electrodes (see element 90 shown in Fig. 9, measure electrical characteristic associated with coil 44, 46 or 48).
With respect to claim 35, Silwa discloses the method of claim 34, wherein the determining a contact status of the one or more other electrodes located closer to the first electrode are given greater weight than the determined contact status of the one or more other electrodes located further from the first electrode (receive a plurality of input signals including signals generated by ablation generator 18, electrodes 42 and coils 44, 46, 48, 50 on catheter 16, and RCGS 20 and generate a plurality of output signals including those used to control and/or provide data to electrode 42 and coils 44, 46, 48, 50 on catheter 16, ablation generator 18, RCGS 20, field generator 22 and display system 24).
With respect to claim 36, Silwa discloses the method of claim 34, wherein determining a contact status for the first electrode is based further on a contact status history of the first electrode (see electrodes 42, 44, 46 and 48 in a vertical direction shown in Fig. 3).
With respect to claim 37, Silwa discloses the method of claim 34, wherein determining a contact status for the first electrode is based further on contact status history of the one or more other electrodes (if intermediate tip portion 66 is compressed axially in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in each coil 44, 46, 48 will increase as coil 50 moves closer to coils 44, 46, 48. If distal tip portion 64 bends relative to axis 74 in response to contact of the distal end 40 of shaft 36 with tissue 12, the inductance in certain coils 44, 46, 48, will increase while the inductance in other coils 44, 46, 48, will decrease as coil 50 moves closer to certain coils 44, 46, 48 and farther away from other coils 44, 46, 48 and angulates relative to the coils 44, 46 48).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FARHANA AKHTER HOQUE whose telephone number is (571)270-7543. The examiner can normally be reached Monday-Friday, 7:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eman A Alkafawi can be reached at 571-272-4448. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FARHANA A HOQUE/ Primary Examiner, Art Unit 2858
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