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 Objections
Claim 4 is objected to because of the following informalities: “the ablation electrode” should be –the at least one ablation electrode—; as introduced in claim 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “the ablation electrode” should be –the at least one ablation electrode—; as introduced in claim 1. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “the ablation electrode” should be –the at least one ablation electrode—; as introduced in claim 1. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “the ablation electrode” should be –the at least one ablation electrode—; as introduced in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “at least one ablation electrode disposed at a distal part of the insertion member; a transducer disposed at a distal part of the insertion member” it is unclear if “a distal part of the insertion member” where the transducer is disposed is the same or different than the “a distal part of the insertion member” where the ablation electrode is disposed (e.g. it is unclear how many distal parts the insertion member comprises); which renders the claim indefinite. For examination purposes the examiner is considering “a transducer disposed at a distal part of the insertion member” to be – a transducer disposed at [[a]]the distal part of the insertion member—, as a distal part is already introduced in claim 1. Dependent claims 2-13 are rejected by virtue of their dependency on independent claim 1. The examiner further notes that “the ablation electrode” (line 7) should be –the at least one ablation electrode—; as introduced in claim 1.
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 1-2, 4-5, 7-10, & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti (US 20160030108 A1), hereinafter “Lupotti”, in view of Roy et al. (US 20250273330 A1; effectively filed 09/09/2022), hereinafter “Roy”.
Regarding claim 1, as best understood in view of the 112(b) rejection above, Lupotti discloses an ablation system, comprising: an insertion member having a distal end and a proximal end and extending in a longitudinal direction ([0021] & [0037]; Figure 3—element 30); at least one ablation electrode disposed at a distal part of the insertion member ([0021] & [0037]; Figure 3—element 42); a transducer disposed at a distal part of the insertion member and capable of transmitting and receiving ultrasound ([0034] & [0037]; Figure 3—element 52); and a generator electrically connected to the ablation electrode ([0019]; Figure 1—element 20).
Lupotti does not explicitly disclose the generator being a pulse voltage generator.
Roy teaches an ablation system comprising a generator ([0204]; Figure 5—element 308); the generator being a pulse voltage generator ([0204] & [0206]; Figure 5—element 308; the generator 308 may deliver traditional ablation energy or pulsed frequency ablation energy).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the ablation generator, as disclosed by Lupotti, to include a pulse voltage generator, as taught by Roy, as both references and the claimed invention are directed toward ablation systems comprising ablation generators. As disclosed by Lupotti, the ablation electrodes may be coupled to an ablation generator that is configured to deliver RF energy or the system can be configured for ablation through means other than RF ([0025]). As disclosed by Roy, the ablation generator may deliver RF energy or pulse frequency ablation (PFA) energy to ablate tissue ([0206]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ablation generator, as disclosed by Lupotti, to include a pulse voltage generator, as taught by Roy, as providing a pulsed voltage ablation generator is a known and suitable alternative in the art to providing a traditional RF ablation generator and such a modification would provide for suitable ablation through means other than RF energy.
Regarding claim 2, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti further discloses a signal generator electrically connected to the transducer ([0019]; Figure 1—element 22); and a controller ([0026]).
Lupotti does not disclose the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator.
Roy further teaches an ultrasound transducer for imaging electrically connected to a signal generator ([0197] & [0204]-[0206]; Figure 5—elements 307), an a controller ([0197] & [0204]; Figure 5—element 123); the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator ([0204]-[0206]; Figure 6—element 361; the synchronization circuitry 361 switches rapidly between the ultrasound circuitry and the ablation circuitry so that the ultrasound imaging frames can be acquired between the durations of pulses of RF energy application).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller and the timing of the signal being delivered to the transducer, as disclosed by Lupotti, to include the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator, as further taught by Roy, as both references and the claimed invention are directed toward ablation systems comprising ablation generators and ultrasound imaging devices. As disclosed by Roy, during ablation radiofrequency interference between the ablation system and the ultrasound system usually causes the quality of the ultrasound images to significantly degrade, this problem of interference can be solved by having the two modalities controlled together via a synchronization circuitry such that ultrasound imaging can be acquired between the durations of pulses of RF energy ([0204]-[0206] & [0223]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller and the timing of the signal being delivered to the transducer, as disclosed by Lupotti, to include the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator, as further taught by Roy, as such a modification would prevent interference between the ablation system and the ultrasound system which can cause the quality of the ultrasound images to significantly degrade.
Regarding claim 4, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti further discloses wherein the insertion member has a tip member at the distal part thereof, and the ablation electrode is disposed on the tip member ([0021]; Figure 3—element 32; the examiner is considering the tip member to be the distal end 32 of the insertion member 30 containing the ablation electrode 42).
Regarding claim 5, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti further discloses wherein the transducer includes a plurality of ultrasound transducer elements ([0037]; one or more transducers may be used in addition to the ultrasound transducer 52).
Regarding claim 7, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti further discloses wherein the insertion member has a lumen extending in the longitudinal direction, the insertion member has a shaft that is slidably disposed in the lumen and that has a distal end and a proximal end, and the transducer is disposed at a distal part of the shaft ([0033] & [0037]; Figure 3—element 53; the examiner is considering the shaft to be the shaft/movement mechanism that allows the transducer 53 to rotate and move within the insertion member 30).
Regarding claim 8, Lupotti in view of Roy disclose all of the limitations of claim 7, as described above.
Lupotti further discloses wherein the shaft is rotatable about a longitudinal axis of the shaft ([0033] & [0037]; Figure 3—element 53).
Regarding claim 9, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti further discloses an ultrasound imaging device electrically connected to the transducer ([0028]; Figure 1—element 26).
Regarding method claim 10, Lupotti in view of Roy disclose all of the limitations of claim 1, as described above.
Lupotti does not disclose the method comprising supplying pulse currents to the ablation electrode by the pulse voltage generator; and receiving or transmitting ultrasound by the transducer in timing between the pulse currents.
Roy further teaches supplying pulse currents to the ablation electrode by the pulse voltage generator; and receiving or transmitting ultrasound by the transducer in timing between the pulse currents ([0204]-[0206]; Figure 6—element 361; the synchronization circuitry 361 switches rapidly between the ultrasound circuitry and the ablation circuitry so that the ultrasound imaging frames can be acquired between the durations of pulses of RF energy application).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of ablating tissue and the timing of receiving or transmitting ultrasound by the transducer, as disclosed by Lupotti, to include supplying pulse currents to the ablation electrode by the pulse voltage generator; and receiving or transmitting ultrasound by the transducer in timing between the pulse currents, as further taught by Roy, as both references and the claimed invention are directed toward ablation systems and methods comprising ultrasound imaging devices. As disclosed by Roy, during ablation radiofrequency interference between the ablation system and the ultrasound system usually causes the quality of the ultrasound images to significantly degrade, this problem of interference can be solved by having the two modalities controlled together via a synchronization circuitry such that ultrasound imaging can be acquired between the durations of pulses of RF energy ([0204]-[0206] & [0223]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of ablating tissue and the timing of receiving or transmitting ultrasound by the transducer, as disclosed by Lupotti, to include supplying pulse currents to the ablation electrode by the pulse voltage generator; and receiving or transmitting ultrasound by the transducer in timing between the pulse currents, as further taught by Roy, as such a modification would prevent interference between the ablation system and the ultrasound system which can cause the quality of the ultrasound images to significantly degrade.
Regarding method claim 12, Lupotti in view of Roy disclose all of the limitations of claim 10, as described above.
Lupotti further discloses wherein the ablation system further comprises: an ultrasound imaging device electrically connected to the transducer ([0028]; Figure 1—element 26); the insertion member having a lumen extending in the longitudinal direction wherein the insertion member has a shaft that is slidably disposed in the lumen and that has a distal end and a proximal end; and the transducer disposed at a distal part of the shaft ([0033] & [0037]; Figure 3—element 53; the examiner is considering the shaft to be the shaft/movement mechanism that allows the transducer 53 to rotate and move within the insertion member 30), the method further comprising imaging signals from the transducer by the ultrasound imaging device while the shaft is rotated ([0033] & [0037]; Figure 3—element 53; the transducer 53 rotates about the transducer axis B to form an imaging plane 60).
Claims 3 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Roy and Altmann et al. (US 20070106146 A1), hereinafter “Altmann”.
Regarding claim 3, Lupotti in view of Roy disclose all of the limitations of claim 2, as described above.
Lupotti does not disclose wherein the controller is configured to cause the transducer to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement.
Altmann teaches an ultrasound imaging and ablation system ([0008]); wherein the controller is configured to cause the transducer to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement ([0070]; the ultrasound images are synchronized with the heart cycle by gating signal and image capture relative to the body-surface electrocardiogram (ECG) signal or intra-cardiac electrocardiogram).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller and the transmitting and receiving of signals by the transducer, as disclosed by Lupotti, to include wherein the controller is configured to cause the transducer to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement, as taught by Altmann, as both references and the claimed invention are directed toward ablation and ultrasound imaging systems. As disclosed by Altmann, the ultrasound images are synchronized with the he heart cycle, by gating signal and image capture relative to a body-surface electrocardiogram (ECG) signal or intra-cardiac electrocardiogram; since features of the heart change their shape and position during the hearts periodic contraction and relaxation, the imaging process is typically performed at a particular timing with respect to this period in order to prevent blurry images ([0011], [0012], & [0070]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller and the transmitting and receiving of signals by the transducer, as disclosed by Lupotti, to include wherein the controller is configured to cause the transducer to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement, as taught by Altmann, as such a modification would prevent blurry images.
Regarding method claim 11, Lupotti in view of Roy disclose all of the limitations of claim 10, as described above.
Lupotti further discloses wherein the ablation system further comprises a signal generator electrically connected to the transducer ([0019]; Figure 1—element 22) and a controller ([0026]).
Lupotti does not disclose the controller configured to cause the signal generator to generate a signal to the transducer in timing between the pulse currents generated by the pulse voltage generator, the method further comprising causing the transducer by the controller to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement.
Roy further teaches an ultrasound transducer for imaging electrically connected to a signal generator ([0197] & [0204]-[0206]; Figure 5—elements 307), an a controller ([0197] & [0204]; Figure 5—element 123); the controller configured to cause the signal generator to generate a signal to the transducer in timing between the pulse currents generated by the pulse voltage generator ([0204]-[0206]; Figure 6—element 361; the synchronization circuitry 361 switches rapidly between the ultrasound circuitry and the ablation circuitry so that the ultrasound imaging frames can be acquired between the durations of pulses of RF energy application).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller and the timing of the signal being delivered to the transducer, as disclosed by Lupotti, to include the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator, as further taught by Roy, as both references and the claimed invention are directed toward ablation systems comprising ablation generators and ultrasound imaging devices. As disclosed by Roy, during ablation radiofrequency interference between the ablation system and the ultrasound system usually causes the quality of the ultrasound images to significantly degrade, this problem of interference can be solved by having the two modalities controlled together via a synchronization circuitry such that ultrasound imaging can be acquired between the durations of pulses of RF energy ([0204]-[0206] & [0223]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller and the timing of the signal being delivered to the transducer, as disclosed by Lupotti, to include the controller configured to cause the signal generator to generate a signal to the transducer in timing between pulse voltages generated by the pulse voltage generator, as further taught by Roy, as such a modification would prevent interference between the ablation system and the ultrasound system which can cause the quality of the ultrasound images to significantly degrade.
Altmann teaches an ultrasound imaging and ablation system and method ([0008]); the method further comprising causing the transducer by the controller to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement ([0070]; the ultrasound images are synchronized with the heart cycle by gating signal and image capture relative to the body-surface electrocardiogram (ECG) signal or intra-cardiac electrocardiogram).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of transmitting and receiving of signals by the transducer, as disclosed by Lupotti, to include the method further comprising causing the transducer by the controller to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement, as taught by Altmann, as both references and the claimed invention are directed toward ablation and ultrasound imaging systems and methods. As disclosed by Altmann, the ultrasound images are synchronized with the he heart cycle, by gating signal and image capture relative to a body-surface electrocardiogram (ECG) signal or intra-cardiac electrocardiogram; since features of the heart change their shape and position during the hearts periodic contraction and relaxation, the imaging process is typically performed at a particular timing with respect to this period in order to prevent blurry images ([0011], [0012], & [0070]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of transmitting and receiving of signals by the transducer, as disclosed by Lupotti, to include the method further comprising causing the transducer by the controller to transmit and receive signals in synchronization with an ECG signal obtained by electrocardiographic measurement, as taught by Altmann, as such a modification would prevent blurry images.
Claims 6 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Roy and Maguire et al. (US 20020087156 A1), hereinafter “Maguire”.
Regarding claim 6, Lupotti in view of Roy disclose all of the limitations of claim 5, as described above.
Lupotti further discloses wherein the ultrasound transducer elements include a second ultrasound transducer element group, the second ultrasound transducer element group is disposed proximal to the ablation electrode ([0037]; Figure 3—elements 42 & 52).
Lupotti does not disclose wherein the ultrasound transducer elements include a first ultrasound transducer element group, the first ultrasound transducer element group is disposed distal to the ablation electrode.
Maguire teaches an ablation system comprising an ablation element ([0160], [0174], & [0175]; Figure 5C—element 120); a traducer configured for transmitting and receiving ultrasound signals; the transducer comprising a plurality of ultrasound transducer elements; wherein the ultrasound transducer elements include a second ultrasound transducer element group, the second ultrasound transducer element group is disposed proximal to the ablation electrode; wherein the ultrasound transducer elements include a first ultrasound transducer element group, the first ultrasound transducer element group is disposed distal to the ablation electrode ([0052], [0190], [0198]-[0200], & [0209]; Figure 5C—elements 516 & 518).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the ultrasound transducer elements including the second proximal ultrasound transducer element group, as disclosed by Lupotti, to further include wherein the ultrasound transducer elements include a first ultrasound transducer element group, the first ultrasound transducer element group is disposed distal to the ablation electrode, as taught by Maguire, as both references and the claimed invention are directed toward ablation systems comprising ultrasound transducers for sensing. As disclosed by Lupotti, one or more transducers may be used ([0037]). As disclosed by Maguire, the ablation system may comprise an ultrasound transducer that is positioned proximal to the ablation element, an ultrasound transducer that is positioned distal to the ablation element, or alternatively may comprise a plurality of ultrasound transducer elements such that a first transducer element is positioned proximal to the ablation element and a second transducer element is positioned distal to the ablation element; by providing the configuration of both proximal and distal transducer elements, the system can provide for more precise positioning of the ablation electrode ([0052], [0190], [0198]-[0200], & [0209]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ultrasound transducer elements including the second proximal ultrasound transducer element group, as disclosed by Lupotti, to further include wherein the ultrasound transducer elements include a first ultrasound transducer element group, the first ultrasound transducer element group is disposed distal to the ablation electrode, as taught by Maguire, as such a modification would provide for more precise positioning of the ablation electrode.
Regarding method claim 13, Lupotti in view of Roy disclose all of the limitations of claim 12, as described above.
Lupotti further discloses wherein: the transducer includes a plurality of ultrasound transducer elements ([0037]; one or more transducers may be used in addition to the ultrasound transducer 52), the ultrasound transducer elements include a second ultrasound transducer element group; the second ultrasound transducer element group is disposed proximal to the ablation electrode ([0037]; Figure 3—elements 42 & 52), the method further comprising imaging signals from the second ultrasound transducer element group by the ultrasound imaging device ([0034] & [0037]).
Lupotti does not disclose the ultrasound transducer elements include a first ultrasound transducer element group, and the first ultrasound transducer element group is disposed distal to the ablation electrode; the method further comprising imaging signals from the first ultrasound transducer element group.
Maguire teaches an ablation system and method comprising an ablation element ([0160], [0174], & [0175]; Figure 5C—element 120); a traducer configured for transmitting and receiving ultrasound signals; the transducer comprising a plurality of ultrasound transducer elements; the ultrasound transducer elements include a second ultrasound transducer element group; the second ultrasound transducer element group is disposed proximal to the ablation electrode; the ultrasound transducer elements include a first ultrasound transducer element group, and the first ultrasound transducer element group is disposed distal to the ablation electrode ([0052], [0190], [0198]-[0200], & [0209]; Figure 5C—elements 516 & 518); the method further comprising imaging signals from the first ultrasound transducer element group ([0209]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the ultrasound transducer elements including the second proximal ultrasound transducer element group and the method of imaging, as disclosed by Lupotti, to further include wherein the ultrasound transducer elements include a first ultrasound transducer element group, and the first ultrasound transducer element group is disposed distal to the ablation electrode; the method further comprising imaging signals from the first ultrasound transducer element group, as taught by Maguire, as both references and the claimed invention are directed toward ablation systems and methods comprising ultrasound transducers for sensing. As disclosed by Lupotti, one or more transducers may be used for imaging ([0037]). As disclosed by Maguire, the ablation system may comprise an ultrasound transducer that is positioned proximal to the ablation element, an ultrasound transducer that is positioned distal to the ablation element, or alternatively may comprise a plurality of ultrasound transducer elements such that a first transducer element is positioned proximal to the ablation element and a second transducer element is positioned distal to the ablation element; by providing the configuration of both proximal and distal transducer elements, the system can provide for more precise positioning of the ablation electrode upon receipt of respective signals ([0052], [0190], [0198]-[0200], & [0209]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ultrasound transducer elements including the second proximal ultrasound transducer element group and the method of imaging, as disclosed by Lupotti, to further include wherein the ultrasound transducer elements include a first ultrasound transducer element group, and the first ultrasound transducer element group is disposed distal to the ablation electrode; the method further comprising imaging signals from the first ultrasound transducer element group, as taught by Maguire, as such a modification would provide for more precise positioning of the ablation electrode.
Conclusion
Accordingly, claims 1-13 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hornung et al. (US 20240090941 A1) provides a teaching for alternating IRE ablation and ultrasound imaging so as to prevent interference ([0059]). Budzelaar et al. (US 20150073404 A1) provides a teaching for ultrasonic sensing between ablation pulses so as to prevent RF interference ([0076]). Suorsa et al. (US 6206831 B1) provides a teaching for wherein the ultrasound transducer elements include a second ultrasound transducer element group, the second ultrasound transducer element group is disposed proximal to the ablation electrode; wherein the ultrasound transducer elements include a first ultrasound transducer element group, the first ultrasound transducer element group is disposed distal to the ablation electrode ([Col. 1, line 65 – Col. 2, line 9]; Figure 3—elements 24 & 28).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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, Joseph Stoklosa can be reached at (571) 272-1213. 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.
/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights