DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/09/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 10/09/2025.
The amendments filed on 10/09/2025 have been entered. Accordingly claims 2-14 and 16-30 remain pending. Claims 2, 4, 18, 23, 26, 27, 29, and 30 are presently amended.
The previous objections to the claims have been withdrawn in light of applicant's amendments to claims 2, 4, 18, 23, and 30. Although examiner notes that there are new objections raised for claim 30 which are detailed below.
The previous rejections of claims 2-14 and 16-29 under 35 U.S.C 112(b) have been withdrawn in light of applicant's amendments to claim 2.
Response to Arguments
Applicant’s arguments regarding the prior art rejection of amended independent claim 2 have been fully considered and are persuasive, in part. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Thapliyal et al. Examiner notes that although previously cited references Kohler and Singh are still relied on in the rejection, they are not relied on to teach the amended limitation requiring each of the one or more ultrasound transducers being configured to emit ultrasound energy for imaging and subsequently heating, perturbing, or destroying the target tissue as presently claimed.
Claim Objections
Claim 30 is objected to because of the following informalities:
Regarding claim 30:
the limitation “(i) obtaining one or more ultrasound images the tissue” in line 8 should be changed to --obtaining one or more ultrasound images of the tissue--;
the limitation “the one or more ultrasound transducer” in line 10 should be changed to –the one or more ultrasound transducers--; and
the limitation “the instrum,ent” in line 12 should be changed to –the instrum[[,]ent--.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-8, 11, 12, and 14, 16, 17, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Köhler et al. (US 2014/0005521, January 2, 2014, applicant submitted prior art via the IDS, hereinafter “Kohler”) in view of Singh et al. (US 11,986,341 B1, filed May 26, 2017) and Thapliyal et al. (US 9,737,323 B2, August 22, 2017).
Regarding claim 2, Kohler discloses an ultrasound ablation and imaging system (“The invention relates to catheters for heating (ablation) a target volume of a subject with ultrasonic energy, in particular the invention relates to the use of capacitive micromachined ultrasonic transducers for generating the ultrasound and the use of medical imaging for controlling the focus of the generated ultrasound.” [0001]; also see “ablation” in e.g. [0002]) comprising:
an ablation unit (catheter as shown in Fig. 8 below and also in Figs. 3-13 and corresponding descriptions) comprising:
an instrument body configured to be inserted into a tissue (catheter 900 shown in re-produced fig. 9 below that is inserted in to a bladder 904), the instrument body comprising a proximal portion and a distal portion (“catheter comprising a shaft with distal and proximal ends.” [0070]);
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one or more ultrasound transducers coupled to the distal portion of the instrument body (catheter as shown in Figs. 3-13 especially the re-produced fig. 8 above and corresponding descriptions);
wherein the one or more ultrasound transducers are arranged to form one or more transducer arrays (“The distal end comprises at least one array of capacitive micromachined ultrasound transducers with an adjustable focus for controllably heating a target zone.” [0070]); and
a monitoring unit (“The CMUT could also be used to monitor the ablation process” [0058]) comprising:
one or more sensors, coupled to the distal portion, configured to measure one or more characteristics of the tissue (“This implies that the flow is CMOS backend compatible and thus CMUT can be combined with other sensors on the same silicon die or the CMUT can even be integrated on top of a dedicated ASIC. Examples are (capacitive) pressure sensors, flow or temperature sensors or an ultrasound micro beam former.” [0053]; also see [0029], [0083]-[0088]), wherein the one or more sensors comprise at least one of the one or more ultrasound transducers (“Send-receive technology can furthermore also be incorporated in the CMUT applicator, thereby allowing for ultrasound imaging as well as HIFU ablation.” [0029]; also see “The CMUT can also be used for ultrasound imaging within these systems or monitoring of ablation or other therapy, although this is at least in part already disclosed as prior art.” [0062]); and
a processor configured to receive and process sensor data of the target tissue or the surrounding tissue to provide real-time ablation monitoring (“The CMUT could also be used to monitor the ablation process: ultrasound monitoring of an RF-ablation process is already being done. It would imply `send and receive electronics`, where an ultrasound measurement is combined with ablation.”; also see “real time forward looking acoustic imaging with a HIFU device for tissue ablation” [0004]; also see [0028], [0062], [0076], [0087], [0088], [0124], [0132]).
Kohler fails to explicitly disclose wherein each of the one or more ultrasound transducers is configured to: (i) generate ultrasound energy at a frequency from 5 MHz to 20 Mhz. Although Kohler does teach wherein each of the one or more ultrasound transducers is configured to, (i) generate ultrasound energy at a frequency from 5 MHz to 8.5 Mhz (“The frequencies typically used in transurethral ultrasound are between 5-8.5 MHz, with larger frequencies being used for more shallow targets due to the improved beam quality and efficient energy absorption at these penetration depths.” [0018]).
However, Singh teaches, in the same field of endeavor, wherein each of the one or more ultrasound transducers is configured to, (i) generate ultrasound energy at a frequency from 5 MHz to 20 Mhz (“Transducer frequency may be in the range of 5 MHz to 20 MHz to cover the appropriate depth required for the application (for example, 0.1-5 cm in depth).” col. 20, ll. 13-16).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein each of the one or more ultrasound transducers is configured to, (i) generate ultrasound energy at a frequency from 5 MHz to 20 Mhz as taught by Singh in order to provide appropriate depth penetration required for a particular application (col. 20, ll. 13-16 of Singh).
Although Kohler discloses the one or more ultrasound transducers being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue (“the imaging and the heating of the target zone are performed by alternating the two. This embodiment is particularly advantageous because ultrasound imaging may be used for measuring the effectiveness of the heating of the target zone and may also be used for an input to an algorithm for controlling where the catheter heats.” [0076]; also see “the arrays 1008 and the integrated circuit 1102 can be used for ablation and/or for performing diagnostic ultrasound” [0136] and [0029]), Kohler is silent on wherein each of the one or more ultrasound transducers is configured to: (ii) emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue. In other words, while Kohler discloses that the array of transducers being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue, Kohler does not explicitly state that each transducer being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue.
However, Thapliyal teaches, in the same field of endeavor, wherein each of the one or more ultrasound transducers is configured to: (ii) emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue (“The transducer element may comprise a substantially flat circular disc, and the transducer element may operate at a first power level in a first frequency range and a second power level in a second frequency range. The first frequency range may be used for ultrasonically imaging tissue and the second frequency range may be used for creating tissue lesions.” col. 6, ll. 50-57).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein each of the one or more ultrasound transducers is configured to: (ii) emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue as taught by Thapliyal in order to provide a more compact combined device with combined imaging and ablation capabilities (col. 4, ll. 34-67 of Thapliyal).
Regarding claim 3, Kohler further discloses wherein the one or more sensors comprise a temperature sensor, pressure sensor, force sensor, magnetic sensor, acoustic sensor, optical sensor, or displacement sensor (“This implies that the flow is CMOS backend compatible and thus CMUT can be combined with other sensors on the same silicon die or the CMUT can even be integrated on top of a dedicated ASIC. Examples are (capacitive) pressure sensors, flow or temperature sensors or an ultrasound micro beam former.” [0053]).
Regarding claim 4, Kohler further discloses wherein the processor is configured to determine a tissue property based on the measured one or more characteristics of the tissue, the tissue property comprising one or more of an acoustic property, thermal property, thermal propagation property, or a mechanical property (“This embodiment is particularly advantageous because the temperature in the vicinity of the at least one array of capacitive micromachined ultrasound transducers may be measured directly. This may be used to ensure that a subject is not damaged or hurt by too high a temperature achieved by the ultrasound transducers [...] This would further ensure that even a region of the ultrasound transducers does not become overheated.” [0087]; also see [0099], also see “Ultrasound may also be useful to determine temperature and acquire thermal imaging data. This may be accomplished in several ways. For instance ultrasound may be used to determine temperature by measuring: echo shifts due to changes in tissue thermal expansion and speed of sound, variations in the attenuation coefficient, and/or change in backscattered energy from tissue inhomogeneities.” [0101]).
Regarding claim 5, Kohler further discloses wherein the processor is configured to determine a change in the tissue property from the one or more measured characteristics of the tissue (“For instance ultrasound may be used to determine temperature by measuring: echo shifts due to changes in tissue thermal expansion and speed of sound, variations in the attenuation coefficient, and/or change in backscattered energy from tissue inhomogeneities.” [0101]).
Regarding claim 6, Kohler further discloses wherein the processor is configured to receive an initial set of acoustic information or an initial ultrasound image, and wherein the processor is further configured to use the measured one or more characteristics of the tissue to update a tissue model based on the initial set of set of acoustic information or the initial ultrasound image (“The ultrasound imaging may in some embodiments be performed onboard in the integrated circuit. In other embodiments the data acquired from the capacitive micromachined ultrasound transducers may be sent out on the data bus.” [0076]; also see “The target zone may be registered using known image registration techniques. For instance certain anatomical landmarks may be found in the medical image or medical image data or a model such as a deformable-shaped model [tissue model] may be fit to the medical image data or the medical image. The instructions further cause the processor to generate focus control signals to control the focus such that the target zone is heated using the at least one array of capacitive micromachined ultrasound transducers. This embodiment is advantageous because a particular target zone is selected and targeted by the medical imaging system.” [0097]; also see [0139]).
Regarding claim 7, Kohler further discloses wherein the tissue model comprises at least one of a thermal model, a thermal propagation model, or a deformable image model (“For instance certain anatomical landmarks may be found in the medical image or medical image data or a model such as a deformable-shaped model may be fit to the medical image data or the medical image. The instructions further cause the processor to generate focus control signals to control the focus such that the target zone is heated using the at least one array of capacitive micromachined ultrasound transducers. This embodiment is advantageous because a particular target zone is selected and targeted by the medical imaging system. In some embodiments a treatment plan or other planning data may be used to specify the target zone in advance.” [0097]; also see “thermal map” in [0129]).
Regarding claim 8, Kohler further discloses wherein the processor is configured to continuously update the tissue model (“In some embodiments the sonication and the ultrasound imaging occur simultaneously. Some capacitive micromachined ultrasound transducers could be driven at a first frequency for performing the sonication and other ultrasound transducers could be driven at a second frequency for performing imaging. In this way the imaging and the heating or sonication of the target zone could be performed simultaneously.” [0076]; also see “real time forward looking acoustic imaging” [0004]).
Regarding claim 11, Kohler further discloses wherein the processor is configured to determine one or more optimal thermal control strategies (“Execution of the instructions further causes the processor to reconstruct a thermal map using the thermal imaging data. A thermal map as used herein encompasses location specific temperature or description of temperature. For instance a thermal map may be superimposed on another medical image to indicate the temperature of different anatomical regions. The focus control signals are generated in accordance with the thermal map. That is to say the focus control signals may be generated using the thermal imaging data and/or the medical image data. The focus control signals can therefore be used to take into account internal anatomy of the subject and/or the temperature of different anatomical regions. This for instance may be used to ensure that a certain anatomical region is heated above a certain threshold temperature and is held there for a predetermined amount of time. This may be useful for inducing necrosis of cells or it may also be useful for activating thermally sensitive drugs or contrast agents.” [0098]) and control one or more parameters of the at least one or more ultrasound transducers to adjust an ablation zone (“The focus control signals are generated in accordance with the thermal map. That is to say the focus control signals may be generated using the thermal imaging data and/or the medical image data. The focus control signals can therefore be used to take into account internal anatomy of the subject and/or the temperature of different anatomical regions” [0098]; also see “If there is a mechanical system for directly focusing the catheter interface the focus control signals may cause the interface to actuate that portion of the catheter which controls the mechanical aspect of the focus. If individual capacitive micromachined ultrasound transducers are controlled by the interface then the focus control signals may comprise instructions for controlling the power delivered to the micromachined ultrasound transducers.” [0123]).
Regarding claim 12, Kohler further discloses wherein the processor is configured to adjust one or more acoustic energy parameters of the one or more ultrasound transducers or drive signals to the one or more ultrasound transducers in response to a sensed signal received by the one or more sensors (“The focus control signals are generated in accordance with the thermal map. That is to say the focus control signals may be generated using the thermal imaging data and/or the medical image data. The focus control signals can therefore be used to take into account internal anatomy of the subject and/or the temperature of different anatomical regions” [0098]; also see “If individual capacitive micromachined ultrasound transducers are controlled by the interface then the focus control signals may comprise instructions for controlling the power delivered to the micromachined ultrasound transducers.” [0123]).
Regarding claim 14, Kohler further discloses wherein the one or more ultrasound transducers are CMUTs (“wherein the distal end comprises at least one array of capacitive micromachined ultrasound transducers” Abstract).
Regarding claim 16, Kohler further discloses each of the one or more transducer arrays comprise a first set of the ultrasound transducers configured to perform imaging and a second set of the one or more ultrasound transducers configured to perform ablation (“Some capacitive micromachined ultrasound transducers could be driven at a first frequency for performing the sonication [ablation] and other ultrasound transducers could be driven at a second frequency for performing imaging.” [0076]; also see “ablation” in e.g., [0026]).
Regarding claim 17, Kohler further discloses wherein the one or more ultrasound transducers comprise a plurality of ultrasound transducers (“A typical two dimensional transducer array currently may have 2000-3000 piezoelectric transducer elements. When fabricated as a CMUT array, over one million CMUT cells may be used.” [0009]), wherein the plurality of ultrasound transducers are configured to be independently controlled to alternate between ultrasound imaging and acoustic ablation (“Some capacitive micromachined ultrasound transducers could be driven at a first frequency for performing the sonication and other ultrasound transducers could be driven at a second frequency for performing imaging. In this way the imaging and the heating or sonication of the target zone could be performed simultaneously. In other embodiments the imaging and the heating of the target zone are performed by alternating the two.” [0076]; also see Fig. 4 and corresponding description, also see “An integrated circuit can be used which can drive individual capacitive micromachined ultrasound transducers or can be used to drive groups or arrays of capacitive micromachined ultrasound transducers.” [0075]).
Regarding claim 27, Kohler further discloses wherein each of the one or more ultrasound transducers are configured to receive wideband acoustic data reflected from the target tissue or surrounding tissue in response to an emitted ultrasound energy (“The CMUT can also be used for ultrasound imaging within these systems or monitoring of ablation or other therapy,” [0062]; examiner notes that CMUTs are configured to receive wideband acoustic data).
Regarding claim 28, Kohler further discloses wherein the wideband acoustic data reflected from the target tissue or surrounding tissue was reflected from one tissue type or a homogeneous region (“target tissue” [0006]; also see [0007]; examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim).
Regarding claim 29, Kohler further discloses wherein the processor is configured to estimate a temperature of the target tissue or surrounding tissue based on the wideband acoustic data reflected from the target tissue or surrounding tissue (“Ultrasound may also be useful to determine temperature and acquire thermal imaging data. This may be accomplished in several ways. For instance ultrasound may be used to determine temperature by measuring: echo shifts due to changes in tissue thermal expansion and speed of sound, variations in the attenuation coefficient, and/or change in backscattered energy from tissue inhomogeneities.” [0101]).
Claims 9-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kohler in view of Singh and Thapliyal as applied to claims 2 and 6 above and further in view of Boctor et al. (US 2021/0196229, July 1, 2021, hereinafter “Boctor”).
Regarding claim 9, Kohler discloses the limitations of claim 6 as stated above and Kohler further discloses wherein the processor is configured to update a deformable image model of the tissue model to align subsequent ultrasound images with the initial ultrasound image (“The target zone may be registered using known image registration techniques. For instance certain anatomical landmarks may be found in the medical image or medical image data or a model such as a deformable-shaped model may be fit to the medical image data or the medical image. The instructions further cause the processor to generate focus control signals to control the focus such that the target zone is heated using the at least one array of capacitive micromachined ultrasound transducers. This embodiment is advantageous because a particular target zone is selected and targeted by the medical imaging system.” [0097]).
Kohler fails to disclose wherein the processor is configured to use a thermal propagation model to process acoustic data.
However, Boctor teaches, in the same field of endeavor, wherein the processor is configured to use a thermal propagation model to process acoustic data (“FIG. 9C is a diagram of an example model to obtain improved temperature monitoring during thermal ablation. In some implementations, the model may include a thermal propagation model that is associated with an ultrasound simulation tool to simulate intra-operative quantities (e.g., time of flight, brightness (B-mode) images, attenuation, speed of sound, and/or the like). Simulated quantities may be compared with actual measurements that are obtained intra-operatively. In some implementations, an optimization model may be utilized to estimate parameters of the thermal propagation model to provide an updated real-time thermal monitoring.” [0071]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the processor is configured to use a thermal propagation model to process acoustic data as taught by Boctor in order to improve thermal map reconstruction from intra-operative ultrasound measurements ([0072] of Boctor).
Regarding claim 10, Kohler modified by Singh, Thapliyal, and Boctor discloses the limitations of claim 9 as stated above, in particular Boctor was relied on to teach the thermal propagation model of claim 9. Kohler fails to disclose wherein the processor is configured to update the thermal propagation model using one or more of a deformation estimate, an intensity analysis over time, or a temperature measurement.
However, Boctor further teaches, in the same field of endeavor, wherein the processor is configured to update the thermal propagation model using one or more of a deformation estimate, an intensity analysis over time, or a temperature measurement (“In some implementations, a thermal propagation model may provide temperature and thermal dose damage simulations to adjust the real-time thermal monitoring system. In some implementations, a reconstructed real-time thermal map may provide feedback to a computational simulation to correct for the model parameters.” [0069]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the processor is configured to update the thermal propagation model using one or more of a deformation estimate, an intensity analysis over time, or a temperature measurement as taught by Boctor in order to correct for model parameters ([0069] of Boctor).
Regarding claim 13, Kohler modified by Singh and Thapliyal discloses the limitations of claim 2 as stated above but fails to disclose wherein the processor is configured to one or more of (i) run a simulated ablation treatment to determine a particular ablation treatment having a desired outcome or (ii) receive a user input for a desired ablation treatment. Although Kohler discloses receiving user input ([0069]) and receiving a treatment plan or other planning data (“In some embodiments a treatment plan or other planning data may be used to specify the target zone in advance.” [0097]).
However, Boctor teaches, in the same field of endeavor, wherein the processor is configured to one or more of (i) run a simulated ablation treatment to determine a particular ablation treatment having a desired outcome (“According to some implementations, a method may include obtaining patient-specific simulation data including expected temperature-dependent measurements for ultrasound signals to be transmitted through a region of tissue during an ablation procedure; determining a relative geometry between an ultrasound transmitter arranged to transmit the ultrasound signals through the region of tissue during the ablation procedure and an ultrasound receiver arranged to receive the ultrasound signals transmitted by the ultrasound transmitter after the ultrasound signals pass through the region of tissue; calculating actual temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure based on the relative geometry between the ultrasound transmitter and the ultrasound receiver; and performing an action to guide the ablation procedure based on a comparison of the actual temperature-dependent measurements for the ultrasound signals and the expected temperature-dependent measurements for the ultrasound signals” [0005]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the processor is configured to one or more of (i) run a simulated ablation treatment to determine a particular ablation treatment having a desired outcome or (ii) receive a user input for a desired ablation treatment as taught by Boctor in order to improve real-time monitoring of thermal ablation ([0069] of Boctor).
Claims 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kohler in view of Singh and Thapliyal as applied to claim 2 above and further in view of Geva et al. (US 2021/0052873, February 25, 2021, hereinafter “Geva”).
Regarding claim 18, Kohler modified by Singh and Thapliyal discloses the limitations of claim 2 as stated above but fails to disclose wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducer arrays.
However, Geva teaches in the same field of endeavor, wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducer arrays (“The transducer sleeve 22 encapsulates the transducer 30 and defines a volume between the walls of the transducer sleeve 22 and the transducer.” [0075]; also see Figs. 1B, reproduced below, and corresponding description; also see “Expanding at step 1420 expandable portions 24, 26 and transducer sleeve 22, to a pre-determined pressure or volume by a pressurized acoustic fluid (e.g. 20-40 cc of fluid) and keeping expanded portions 24/26 and transducer sleeve 22 at an expanded state” [0151]; also see expandable portion 20 in e.g. Figs. 1A, 2, 3, 4A-D, 6A-E and corresponding descriptions; also see [0057]; examiner notes that catheter tube 11 is analogous to the claimed instrument body which was previously disclosed by Kohler).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducer arrays as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Regarding claim 19, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are disposed on one or more lateral sides of the instrument body.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are disposed on one or more lateral sides of the instrument body (see expandable portion 20 in Fig. 1B, reproduced above, on the lateral sides of the catheter tube 11).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are disposed on one or more lateral sides of the instrument body as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Regarding claim 20, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings extend circumferentially around the instrument body.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings extend circumferentially around the instrument body (“In some embodiments, a diameter D20 of a transducer sleeve 22 is between 5 mm and 15 mm. In some embodiments, a diameter D20 of a transducer sleeve 22 is between 6 mm and 12 mm. In some embodiments, a diameter D20 of a transducer sleeve 22 is between 8 mm and 10 mm.” [0102]; also see Fig. 1B, reproduced above, and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings extend circumferentially around the instrument body as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Regarding claim 21, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are segmented one or more of longitudinally or circumferentially.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are segmented one or more of longitudinally or circumferentially (see longitudinally segmented portions, 22, 24, and 26 in Fig. 1B, reproduced above, and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are segmented one or more of longitudinally or circumferentially as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Regarding claim 22, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 21 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claims 18 and 21. Kohler fails to disclose wherein segments of the one or more segmented expandable coverings are configured to be selectively expanded, and wherein the segments are expanded by an acoustic medium stored in the fluid reservoir.
However, Geva further teaches, in the same field of endeavor, wherein segments of the one or more segmented expandable coverings are configured to be selectively expanded (“In some embodiments, the tube comprises one or more conduits, or in other words, fluid supply channels, (not shown) supplying fluid from a fluid source to one or more ports. The terms “conduits” and “fluid supply channels” as used herein are interchangeable. The one or more fluid supply channels are disposed inside the tube or along an outer surface of the tube. In some embodiments, a fluid flow is generated within the balloon 20 and at least within the internal volume of the transducer sleeve 22 by providing fluid via one of the fluid ports, e.g. port 14, and removing fluid via another fluid port, e.g. port 15.” [0076]; also see “In some embodiments, the tube 11 comprises one or more conduits which supply fluid to one or more of the ports 14/15/17. In some embodiments, each conduit opens to a specific port 14/15/17. In some embodiments, each conduit opens to a separate port 14/15/17. In some embodiments, a conduit opens to at least one of the ports 14/15/17.” [0087]), and wherein the segments are expanded by an acoustic medium stored in the fluid reservoir (“According to some embodiments of the invention, the tube comprises at least one fluid port configured to supply fluid to or remove fluid from at least one of the at least one expandable portion. In some embodiments, the expandable portion is inflated by fluid supplied into the portions via the fluid ports. In some embodiments the transducer sleeve is expandable.” [0057]; also see [0077[).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein segments of the one or more segmented expandable coverings are configured to be selectively expanded, and wherein the segments are expanded by an acoustic medium stored in the fluid reservoir as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Regarding claim 23, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are coupled to the one or more sensors, and wherein the one or more segmented expandable coverings are configured to measure one or more of geometric data or stiffness data of the tissue.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are coupled to the one or more sensors, and wherein the one or more segmented expandable coverings are configured to measure one or more of geometric data or stiffness data of the tissue (“In some embodiments, the catheter for ultrasound-driven treatment of a bladder is configured to comprise energy supply conduits for the ultrasound transducer 30/130/830. Additionally, in some embodiments, the catheter for ultrasound-driven treatment of a bladder comprises one or more thermocouples disposed within one or more of the expandable portions. In some embodiments, the thermocouple is configured to measure fluid temperature within the treatment volume. In some embodiments, one or more thermocouples are configured to measure temperature of the bladder wall tissue to prevent overheating of the wall of the bladder. In some embodiments, one or more of the thermocouples are coupled to the bladder wall. In some embodiments, the thermocouple is configured to measure fluid temperature within one or more of the expandable portions and/or the transducer sleeve. In some embodiments, the thermocouple is configured to measure temperature over the surface of the transducer. In some embodiments, the catheter for ultrasound-driven treatment of a bladder comprises one or more pressure sensors within at least one of the expandable portions configured to monitor fluid pressure within the expandable portion.” [0227]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are coupled to the one or more sensors, and wherein the one or more segmented expandable coverings are configured to measure one or more of geometric data or stiffness data of the tissue as taught by Geva in order to monitor fluid pressure within the expandable portion ([0227] of Geva).
Regarding claim 24, Kohler modified by Singh, Thapliyal, and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are configured to be inflated or deflated to adjust one or more ultrasound or acoustic signal parameters of the one or more ultrasound transducers.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are configured to be inflated or deflated to adjust one or more ultrasound or acoustic signal parameters of the one or more ultrasound transducers (“In some embodiments, at least one of the proximal and/or distal expandable portion 24/26 is filled with fluid which has high acoustic impedance and therefore is non-conducive to ultrasound energy. In some embodiments, the non-conducive fluid inflates at least one of the proximal and/or distal expandable portion 24/26. In some embodiments, the non-conducive fluid prevents transmission of ultrasound energy to the untreated areas of the bladder (e.g., the trigone).” [0096]; also see “For example, FIG. 12 shows an embodiment in which the expandable portion 824 is toroidal in geometry. In some embodiments, catheter 811 comprises a therapeutic fluid port 816 between a transducer sleeve 822 and the expandable portion 824. In the exemplary embodiment shown in FIG. 12, toroidal expandable portion 824 when inflated, expands distally, along catheter tube 811 towards tip 802 as indicated by arrows 850 and directing any therapeutic fluid supplied via therapeutic fluid port 816 into treatment volume 807 to surround transducer 830 thus increasing treatment efficacy.” [0224]; also see [0066]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are configured to be inflated or deflated to adjust one or more ultrasound or acoustic signal parameters of the one or more ultrasound transducers as taught by Geva in order to increase treatment efficacy ([0224] of Geva).
Regarding claim 25, Kohler modified by Singh and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are configured to be in inflated such that the temperature of the ablation unit or the target tissue is reduced.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are configured to be in inflated such that the temperature of the ablation unit or the target tissue is reduced (“In some embodiments of the invention, the fluid cools the enclosed transducers. In some embodiments the fluid is an acoustic fluid for an efficient delivery of acoustic waves produced by a transducer.” [0060]; also see “The temperature of the bladder treated surface 5′ is correlated with the heat given off by the transducer. Therefore, increasing the distance between the transducer 30 and the bladder treated surface 5′ prevents over-heating of the bladder treated surface 5′. In some embodiments, increasing the distance between the transducer 30 and the bladder treated surface 5′ permits heating of the transducer 30 to higher temperatures, for example, by increasing on-time and/or frequency emitted by the transducer.” [0100]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are configured to be in inflated such that the temperature of the ablation unit or the target tissue is reduced as taught by Geva in order to prevent tissue from overheating ([0077] of Geva).
Regarding claim 26, Kohler modified by Singh and Geva discloses the limitations of claim 18 as stated above, in particular Geva was relied on to teach the one or more segmented expandable coverings of claim 18. Kohler fails to disclose wherein the one or more segmented expandable coverings are configured to change from a first position, wherein the one or more segmented expandable coverings are flat against the distal portion, to a second position, wherein the one or more segmented expandable covers expand radially from the distal portion.
However, Geva further teaches, in the same field of endeavor, wherein the one or more segmented expandable coverings are configured to change from a first position, wherein the one or more segmented expandable coverings are flat against the distal portion, to a second position, wherein the one or more segmented expandable covers expand radially from the distal portion (see inflated states of expandable portions in e.g. Figs. 2, 3, 8B, 11, 12, 13, 14 and corresponding descriptions; also see “at least one expandable portion is expandable inside a bladder from a contracted state to an expanded state” [0023]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the one or more segmented expandable coverings are configured to change from a first position, wherein the one or more segmented expandable coverings are flat against the distal portion, to a second position, wherein the one or more segmented expandable covers expand radially from the distal portion as taught by Geva in order to create a sealed volume within the treatment area ([0023] of Geva).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Kohler in view of Thapliyal and Geva.
Regarding claim 30, Kohler discloses an ultrasound ablation and imaging system (“The invention relates to catheters for heating (ablation) a target volume of a subject with ultrasonic energy, in particular the invention relates to the use of capacitive micromachined ultrasonic transducers for generating the ultrasound and the use of medical imaging for controlling the focus of the generated ultrasound.” [0001]; also see “ablation” in e.g. [0002]) comprising:
an ablation unit (catheter as shown in Fig. 8 below and also in Figs. 3-13 and corresponding descriptions) comprising;
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an instrument body configured to be inserted into a tissue (catheter 900 shown in re-produced fig. 9 below that is inserted in to a bladder 904), the instrument body comprising a proximal portion and a distal portion (“catheter comprising a shaft with distal and proximal ends.” [0070]);
one or more ultrasound transducers coupled to the distal portion of the instrument body (catheter as shown in Figs. 3-13 especially the re-produced fig. 8 above and corresponding descriptions),
wherein the one or more ultrasound transducer are arranged to form one or more transducer arrays (“The distal end comprises at least one array of capacitive micromachined ultrasound transducers with an adjustable focus for controllably heating a target zone.” [0070]), and
a monitoring unit (“The CMUT could also be used to monitor the ablation process” [0058]) comprising;
one or more sensors, coupled to the distal portion, configured to measure one or more characteristics of the tissue (“This implies that the flow is CMOS backend compatible and thus CMUT can be combined with other sensors on the same silicon die or the CMUT can even be integrated on top of a dedicated ASIC. Examples are (capacitive) pressure sensors, flow or temperature sensors or an ultrasound micro beam former.” [0053]; also see [0029], [0083]-[0088]); and
a processor (“processor” [0076]; also see [0088]) configured to receive and process sensor data to provide real-time ablation monitoring (“The CMUT could also be used to monitor the ablation process: ultrasound monitoring of an RF-ablation process is already being done. It would imply `send and receive electronics`, where an ultrasound measurement is combined with ablation.”; also see “real time forward looking acoustic imaging with a HIFU device for tissue ablation” [0004]; also see [0028], [0062], [0087], [0124], [0132]).
Although Kohler discloses the one or more ultrasound transducers being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue (“the imaging and the heating of the target zone are performed by alternating the two. This embodiment is particularly advantageous because ultrasound imaging may be used for measuring the effectiveness of the heating of the target zone and may also be used for an input to an algorithm for controlling where the catheter heats.” [0076]; also see “the arrays 1008 and the integrated circuit 1102 can be used for ablation and/or for performing diagnostic ultrasound” [0136] and [0029]), Kohler is silent on wherein each of the one or more ultrasound transducers is configured to: (ii) emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue. In other words, while Kohler discloses that the array of transducers being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue, Kohler does not explicitly state that each transducer being configured to emit the ultrasound energy for (a) obtaining one or more ultrasound images of a target tissue or a surrounding tissue and subsequently (b) heating, perturbing, or destroying the target tissue.
However, Thapliyal teaches, in the same field of endeavor, wherein each of the one or more ultrasound transducers are configured for emitting energy for (i) obtaining one or more ultrasound images the tissue and subsequently (ii) heating, perturbing, or destroying the tissue (“The transducer element may comprise a substantially flat circular disc, and the transducer element may operate at a first power level in a first frequency range and a second power level in a second frequency range. The first frequency range may be used for ultrasonically imaging tissue and the second frequency range may be used for creating tissue lesions.” col. 6, ll. 50-57).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein each of the one or more ultrasound transducers are configured for emitting energy for (i) obtaining one or more ultrasound images the tissue and subsequently (ii) heating, perturbing, or destroying the tissue as taught by Thapliyal in order to provide a more compact combined device with combined imaging and ablation capabilities (col. 4, ll. 34-67 of Thapliyal).
Kohler also fails to disclose wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, each of the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducers.
However, Geva teaches in the same field of endeavor, wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, each of the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducers (“The transducer sleeve 22 encapsulates the transducer 30 and defines a volume between the walls of the transducer sleeve 22 and the transducer.” [0075]; also see Figs. 1B, reproduced below, and corresponding description; also see “Expanding at step 1420 expandable portions 24, 26 and transducer sleeve 22, to a pre-determined pressure or volume by a pressurized acoustic fluid (e.g. 20-40 cc of fluid) and keeping expanded portions 24/26 and transducer sleeve 22 at an expanded state” [0151]; also see expandable portion 20 in e.g. Figs. 1A, 2, 3, 4A-D, 6A-E and corresponding descriptions; also see [0057]; examiner notes that catheter tube 11 is analogous to the claimed instrument body which was previously disclosed by Kohler).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kohler with wherein the instrument body further comprises one or more segmented expandable coverings coupled to the distal portion of the instrument body, each of the one or more segmented expandable coverings extending over and encapsulating at least one of the one or more transducers as taught by Geva in order to prevent direct contact between the transducer and the treated tissue ([0092] of Geva).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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