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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shameli (US Patent No 20180311467) in view of Ngo (US Patent No 20170319260) .
Regarding claim 1, Shameli teaches a medical probe comprising (medical catheter apparatus 20, [0035]): a shaft extending along a longitudinal axis (see catheter 22 extending in a longitudinal direction, fig 1); a transmitting coil disposed within the shaft (see transmitting coil 33 which is disposed in the shaft 22, [0044]), aligned along the longitudinal axis and configured to generate a first alternating magnetic field (an alternating current is passed through the transmitting coil, causing a first alternating magnetic field to be generated, [0032]); a location element coupled to distal end (see the sensor element, which may also be seen as a location element found on the distal end, [0032]), configured to move in relation to the transmitting coil in response to a force on the distal portion (mechanical forces are applied to the force sensor when the catheter is being positioned causing movement on the force sensing apparatus, [0032]), and configured to generate a second alternating magnetic field based at least in part on the first alternating magnetic field and based in part on a position of the location element in relation to the transmitting coil (the first magnetic field induces eddy currents within the force sensing apparatus which then generates a secondary magnetic field to be detected by receiving coils, [0032]); and a plurality of receiving coils disposed within the shaft (receiving coils 36 found within the catheter 22, [0045]) and configured to output a respective electrical signal based at least in part on a superposition of the first alternating magnetic field and the second alternating magnetic field (in which the coils generate signals indicative of the position and orientation of the catheter in response to the generated magnetic field, [0045]).
Shameli does not teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket; one or more electrodes coupled to each spine of the plurality of spines.
However, using a basket catheter configuration which contains coupled electrodes is well known and obvious for one skilled in the art. See for example the analogous sensing and ablation catheter disclosed by Ngo which does teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket (see from Ngo, in which the flexible spines 206 form a basket assembly, [0073], see also fig 3); one or more electrodes coupled to each spine of the plurality of spines (see from Ngo, in which each of the plurality of flexible spines contains multiple electrodes 240, [0073]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical catheter with eddy current and magnetic field transmitting capabilities taught by Shameli, in order to contain the electrode basket assembly taught by Ngo, as it is another known catheter structure and deployment method in the art for deploying sensing and treatment end effectors into the body, as taught by Ngo, [0073].
Regarding claim 2, Shameli teaches the medical probe of claim 1, the location element comprising an electrically conductive, non-ferromagnetic material (see in which the force sensor or location element comprises a conductive plate or any suitable conducting element, [0032]).
Regarding claim 3, Shameli teaches the medical probe of claim 1, the transmitting coil and the location element being configured such that the first alternating magnetic field induces eddy currents in the location element and the eddy currents generate the second alternating magnetic field (the first magnetic field induces eddy currents within the force sensing apparatus which then generates a secondary magnetic field to be detected by receiving coils, [0032]).
Regarding claim 4, Shameli teaches the medical probe of claim 1, the plurality of receiving coils each being aligned along the longitudinal axis (see from the fig 2, in which receiving coils 36 are aligned along the longitudinal axis).
Regarding claim 5, Shameli teaches the medical probe of claim 1, the plurality of receiving coils comprising three receiving coils disposed symmetrically about the longitudinal axis, wherein at least a portion of the plurality of receiving coils is circumscribed by the transmitting coil (in which there may be three receiving coils 36 disposed about the longitudinal axis, [0045], and see from fig 2 in which they are circumscribed by the transmitting coil 33).
Regarding claim 6, Shameli teaches the medical probe of claim 1, further comprising: a three-axis sensor disposed within the shaft and configured to output signals indicative of a position and orientation of the three-axis sensor relative to a magnetic field generated externally from the medical probe (there may also be magnetic field sensing coils 37 which generate signals indicative of the position and orientation of the catheter, thereby being a three axis sensor, in response to external magnetic field components, [0045]).
Regarding claim 7, Shameli teaches the medical probe of claim 1, the one or more electrodes configured to sense intracardiac electrogram signals, provide radio frequency signals to ablate tissue, and/or provide at least 900 V between electrodes to ablate tissue with irreversible electroporation (see in which the apparatus 20 is used to measure cardiac features of the patient and then configured to ablate cardiac tissue in response, [0036]).
Regarding claim 8, Shameli teaches a medical system comprising: a signal generator (signal generator 28, [0036]) configured to provide an output signal to a transmitting coil disposed in a shaft of a medical probe (see transmitting coil 33 which is disposed in the shaft 22, [0044]); and a signal processor (Processor 30, [0041]) configured to: receive a plurality of input signals from a plurality of receiving coils disposed in the shaft of a catheter (receiving coils 36 found within the catheter 22, [0045]), and determine a position of an electrically conductive, non-ferromagnetic element (see in which the force sensor or location element comprises a conductive plate or any suitable conducting element, [0032]) coupled to distal end of the catheter based at least in part on a comparison of the output signal to the plurality of input signals (in which the coils generate signals indicative of the position and orientation of the catheter in response to the generated magnetic field, [0045]).
Shameli does not teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket; one or more electrodes coupled to each spine of the plurality of spines.
However, using a basket catheter configuration which contains coupled electrodes is well known and obvious for one skilled in the art. See for example the analogous sensing and ablation catheter disclosed by Ngo which does teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket (see from Ngo, in which the flexible spines 206 form a basket assembly, [0073], see also fig 3); one or more electrodes coupled to each spine of the plurality of spines (see from Ngo, in which each of the plurality of flexible spines contains multiple electrodes 240, [0073]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical catheter with eddy current and magnetic field transmitting capabilities taught by Shameli, in order to contain the electrode basket assembly taught by Ngo, as it is another known catheter structure and deployment method in the art for deploying sensing and treatment end effectors into the body, as taught by Ngo, [0073].
Regarding claim 9, Shameli teaches the medical system of claim 8, the catheter being configured such that the output signal generates a first alternating magnetic field by the transmitting coil (an alternating current is passed through the transmitting coil, causing a first alternating magnetic field to be generated, [0032]), the first alternating magnetic field induces eddy currents in the electrically conductive, non-ferromagnetic element, the eddy currents generate a second alternating magnetic field (the first magnetic field induces eddy currents within the force sensing apparatus which then generates a secondary magnetic field to be detected by receiving coils, [0032]), and a superposition of the first alternating magnetic field and the second alternating magnetic field affects the plurality of input signals (an output signal generates based on the responsive superposition of each magnetic field, [0026]).
Regarding claim 10, Shameli teaches the medical system of claim 8, the signal processor further being configured to: determine a direction and magnitude of a force applied to spines of the multi-electrode basket catheter based at least in part on a comparison of the output signal to the plurality of input signals (see from [0032], in which a force may be applied to the conductive force plate which causes eddy currents to be sent and received via the transmitting and receiving coils, and by analyzing the eddy currents generated the processor may ascertain the position, orientation and magnitude of the external forces).
Regarding claim 11, Shameli teaches the medical system of claim 8, the signal processor further being configured to: determine a deformed shape of the spines of the multi-electrode basket catheter based at least in part on a comparison of the output signal to the plurality of input signals (the orientation or shape of the distal end of the catheter may be ascertained in response to the measured force applied which is analyzed via the eddy currents between the transmitting and receiving coils, [0031]).
Regarding claim 12, Shameli teaches the medical system of claim 11, further comprising: a visualization module configured to graphically render the deformed shape for display on a display device and graphically render the deformed shape in relation to an anatomical map (a processor 30 may be embodied to present the signal results from the catheter in a form of a generated display, [0042], seen as an equivalent visualization module).
Regarding claim 13, the combination teaches the medical system of claim 8, further comprising: an intracardiac electrogram (IEGM) sensor configured to receive IEGM signals from electrodes of the multi-electrode basket catheter (see from Ngo, in which the multiple basket electrodes 240 are configured to sense the IEGM signals from the tissue, [0082]).
Regarding claim 14, Shameli teaches the medical system of claim 8, further comprising: an ablation energy generator configured to provide RF signals and/or pulsed signals to electrodes of the multi-electrode basket catheter to perform RF ablation and/or irreversible electroporation of tissue (the catheter 22 is configured to ablate the tissue of a subject by passing ablating current or signals generated by a signal generator to the subject via ablating electrode 21, [0036]).
Regarding claim 15, Shameli teaches a method comprising: generating a first alternating magnetic field from a transmitting coil disposed in a shaft of a catheter (an alternating current is passed through the transmitting coil, causing a first alternating magnetic field to be generated, [0032]); inducing eddy currents on an electrically conductive, non-ferromagnetic element coupled to distal ends of the catheter (the first magnetic field induces eddy currents within the force sensing apparatus which then generates a secondary magnetic field to be detected by receiving coils, [0032]); inducing respective electrical signals in a plurality of receiving coils disposed in the shaft of catheter such that the respective electrical signals are based at least in part on a superposition of the first alternating magnetic field and a second alternating magnetic field generated by the eddy currents (an output signal is generated based on the responsive superposition of each magnetic field, [0026]); and determining a position of the electrically conductive, non-ferromagnetic element (see in which the force sensor or location element comprises a conductive plate or any suitable conducting element, [0032]) based at least in part on the respective electrical signals (in which the coils generate signals indicative of the position and orientation of the catheter in response to the generated magnetic field, [0045]).
Shameli does not teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket; one or more electrodes coupled to each spine of the plurality of spines.
However, using a basket catheter configuration which contains coupled electrodes is well known and obvious for one skilled in the art. See for example the analogous sensing and ablation catheter disclosed by Ngo which does teach a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket (see from Ngo, in which the flexible spines 206 form a basket assembly, [0073], see also fig 3); one or more electrodes coupled to each spine of the plurality of spines (see from Ngo, in which each of the plurality of flexible spines contains multiple electrodes 240, [0073]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical catheter with eddy current and magnetic field transmitting capabilities taught by Shameli, in order to contain the electrode basket assembly taught by Ngo, as it is another known catheter structure and deployment method in the art for deploying sensing and treatment end effectors into the body, as taught by Ngo, [0073].
Regarding claim 16, Shameli teaches the method of claim 15, further comprising: determining a direction and magnitude of a force applied to basket assembly based at least in part on the respective electrical signals (see from [0032], in which a force may be applied to the conductive force plate which causes eddy currents to be sent and received via the transmitting and receiving coils, and by analyzing the eddy currents generated the processor may ascertain the position, orientation and magnitude of the external forces).
Regarding claim 17, Shameli teaches the method of claim 15, further comprising: determining a deformed shape of the basket assembly based at least in part on the respective electrical signals (the orientation or shape of the distal end of the catheter may be ascertained in response to the measured force applied which is analyzed via the eddy currents between the transmitting and receiving coils, [0031]).
Regarding claim 18, Shameli teaches the method of claim 17, further comprising: graphically rendering the deformed shape in relation to an anatomical map (a processor 30 may be embodied to present the signal results from the catheter in a form of a generated display, [0042], seen as an equivalent visualization module).
Regarding claim 19, the combination teaches the method of claim 15, further comprising: receiving intracardiac electrogram signals from electrodes of the multi-electrode basket catheter (see from Ngo, in which the multiple basket electrodes 240 are configured to sense the IEGM signals from the tissue, [0082]).
Regarding claim 20, Shameli teaches the method of claim 15, further comprising: generating radio frequency ablation energy at electrodes of the multi-electrode basket catheter and/or generating pulse-field ablation energy at electrodes of the multi-electrode basket catheter (the catheter 22 is configured to ablate the tissue of a subject by passing ablating current or signals generated by a signal generator to the subject via ablating electrode 21, [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794