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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2025 has been entered.
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 08/25/2025. Claims 1-20 are pending. Claims 1, 4, 6, 8, 10, 13, 16, and 20 are amended. Claims 1-20 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 8-13, filed 08/25/2025, with respect to the rejection of claims 1-20 under 35 U.S.C. 103 have been fully considered and are not persuasive.
Regarding claim 1, the examiner respectfully acknowledges that the has been amended to recite a thermal ablation control system configured to: "monitor a magnetic resonance (MR) thermometry tissue temperature of the target tissue during the thermal ablation of the target tissue; and monitor an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue; and automatically control functions of the thermal energy source, the thermal fiber positioning device, and the MRI system via the communication interface during the thermal ablation of the target tissue at least partially based on the MR thermometry tissue temperature of the target tissue monitored, the MR thermometry tissue temperature of the non-target tissue monitored, a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue, the user input values stored in the memory, and the tissue damage model".
Regarding claim 8, the examiner acknowledges that the claim has been amended to recite a method involving: "monitoring a magnetic resonance (MR) thermometry tissue temperatures of the target tissue during the thermal ablation of the target tissue; monitoring an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue; and automatically controlling, via the controller, the thermal energy source, the thermal fiber positioning device, and the MRI system during the thermal ablation [of] the target tissue at least partially based on the MR thermometry tissue temperature of the target tissue, the MR thermometry tissue temperature of the non-target tissue, a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue, and the tissue damage model".
Regarding claim 13, the examiner acknowledges that the claim has been amended to recite a thermal ablation system with a controller configured to: "automatically control functions of the thermal energy source during a thermal ablation procedure, the thermal fiber positioning device, the MRI system, and the thermal fiber cooling device via the communication interface during thermal ablation of the target tissue at least partially based on the tissue damage model received, a temperature of the target tissue during the thermal ablation of the target tissue, a temperature of the non-target tissue, and a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue".
Among other things, the cited references, whether considered alone or in combination, fail to at least teach, suggest, or disclose the combination of features recited in the currently amended claims.
For instance, the Applicant notes that the currently amended claims provide that, inter alia, the thermal energy source and the thermal fiber positioning device are controlled at least partially based on a temperature of the non-target tissue during the thermal ablation of the target tissue, and a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue. As provided in the specification of the instant application, by evaluating both the temperature of non-target tissue and the thermal dose (e.g., the accumulated thermal energy) absorbed by non-target tissue, critical tissue structures (e.g., the brain stem) which are near a target tissue (e.g., a malignant brain tumor) may be protected even when disrupting nearby tissue. See, e.g., Application-as-Filed, [0101]. Notably, without the thermal dose being evaluated, critical tissue at even low levels of elevated temperature may be damaged or disrupted when heat has been applied for relatively long periods of this time. See, e.g., Application-as-Filed, [0101]. As can be appreciated, the pending claims provide much more robust protection for critical tissue structures during a procedure that applies heat to tissue than conventional methods and systems (e.g., that merely monitor for temperature). See, e.g., Application-as-Filed, [0101].
The Office Action asserts that the computing device (100) of Brannan is configured to automatically control functions of the ablation probe (13) based on "accumulated thermal energy." See, e.g., Office Action, p. 40. Applicant respectfully disagrees with this assertion.
While Brannan generally describes loading a "temperature accumulation profile" (corresponding to the target volume of tissue) and following the "temperature accumulation profile" during the ablation procedure, Applicant can find no disclosure of controlling a thermal energy source and a thermal fiber positioning device at least partially based on a temperature of the non-target tissue during the thermal ablation of the target tissue, and the accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue, as currently claimed. In fact, there is no disclosure in Brannan of any determination of accumulated thermal energy absorbed by a non-target tissue during the thermal ablation of the target tissue.
In contrast, Brannan generally describes "using one or more temperature sensors TS, which continually monitor and provide temperature data" that is correlated in real time to enable implementation" of the "temperature accumulation profiles." See, e.g., Brannan [0050]-[0051]. The "temperature accumulation profiles" of Brannan provide a profile that defines the particular temperature for a target tissue that must be reached at a particular time in an ablation procedure. More specifically, Brannan states that the "temperature accumulation profile" corresponds "to the target volume of tissue" and this profile allows a computing device to "dynamically control the microwave ablation probe in accordance with the temperature of the target volume of tissue at each of the points in time such that the temperature of the target volume of tissue follows the temperature accumulation profile during the ablation procedure. See, e.g., Brannan, Abstract.
The graph illustrating these "temperature accumulation profiles" for various target tissues is shown in Fig. 5 of Brannan. As provided in Fig. 5 of Brannan, each of the temperature accumulation profiles defines a specific temperature for the target tissue to reach at each point in time in the procedure. During the ablation procedure of Brannan, the temperature of the specific target tissue (e.g., liver, lung, kidney) in is continually monitored to ensure that "at each of the point in time" the temperature of the specific target tissue follows the predetermined temperature accumulation profile defined for that specific target tissue (e.g., liver, lung, kidney). Stated another way, the one or more temperature sensors (TS) of Brannan are merely monitoring and providing temperature data of the target tissue over time, which is used to adjust energy output to follow the profile. This functionality of Brannan is essentially equivalent to a temperature feedback loop to ensure a predetermined profile is followed. As can be appreciated, Brannan fails to at least teach or suggest any determination of an accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue, as recited in the currently amended claims.
In contrast to Brannan, the currently amended claims evaluate both the temperature of non-target tissue and the accumulated thermal energy absorbed by non-target tissue during the thermal ablation of the target tissue to, inter alia, control functions of the thermal energy source and the thermal fiber positioning device. As noted in the Application-as-Filed, without evaluating the accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue, critical tissue at even low levels of elevated temperature may be damaged or disrupted when heat has been applied for relatively long periods of time. See, e.g., Application-as-Filed, [0101].
Accordingly, and for at least these reasons, the relevant independent claims are patentable over Brannan, whether considered alone or in combination with any other cited reference. For example, the other cited references fail to at least teach or suggest that which Brannan lacks.
The examiner respectfully acknowledges that Brannan generally describes loading a "temperature accumulation profile" (corresponding to the target volume of tissue, see Brannan: FIG. 5) and following the "temperature accumulation profile" during the ablation procedure.
However, the examiner disagrees that there is no disclosure in Brannan of any determination of accumulated thermal energy absorbed by a non-target tissue during the thermal ablation of the target tissue. The examiner respectfully asserts that Brannan teaches “monitor an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue” (“Referring back to FIG. 1, temperature sensors TS may be utilized with treatment system 10 to constantly observe/monitor tissue temperatures in, or adjacent to, an ablation zone to enable implementation of temperature accumulation profiles 400A (FIG. 4A) and/or safety protocols 600 (FIG. 6). For example, one or more temperature sensors TS may be provided on the ablation probe 130, e.g., adjacent the distal radiating section, and may be configured to measure tissue temperatures in or adjacent to an ablation zone. It should be appreciated that temperature sensors TS may be placed at any suitable location in treatment system 10 to provide temperature information, such as within a generator (not shown), catheters (not shown), proximal and/or distal radiating sections of ablation probe 130, the patient's body, or the like. As such, temperature sensors TS may be configured to provide a greater array of temperature data collection points and provide greater detail on tissue temperature during and/or following an application of energy from ablation probe 130. In an embodiment, temperature sensors TS may also be used to monitor impedance, which may be useful in predicting coagulum formation. Impedance monitoring may be correlated with temperature monitoring for quantitative tissue injury predictions. The temperature sensors TS may be, for example, a radiometer or thermocouple based system, a magnetic resonance imaging (MRI) thermometry system, or any other tissue temperature monitoring system known in the art” [0050].
Therefore, the temperature sensors TS (i.e. MRI thermometry system) is configured to observe/monitor tissue temperatures in, or adjacent to, an ablation zone during and/or following an application of energy from ablation probe 130. Tissues which are adjacent to an ablation zone (i.e. target tissue) include non-target tissue.
In this case, the one or more temperature sensors (TS) of Brannan are monitoring and providing temperature data of the target tissue (i.e. within the ablation zone) and the non-target tissue (i.e. adjacent to the ablation zone), which are used to adjust energy output to follow the profile and/or protect adjacent tissues.
Thus, the examiner respectfully disagrees that Brannan fails to at least teach or suggest any determination of an accumulated thermal energy (i.e. thermal dosage) absorbed by the non-target tissue during the thermal ablation of the target tissue, as recited in the currently amended claims.
Therefore, the examiner respectfully maintains the rejection of claims 1, 8 and 13 under 35 U.S.C. 103 for the reasons stated in the Response to Arguments section above. The rejections of claims 1, 8 and 13 have been updated to reflect the amended limitations as shown in the 35 U.S.C. 103 section below.
Examiner’s Note
Regarding claims 20, the examiner is interpreting the “pre-calculated tissue damage model” to be any model/set of instructions used to assist in estimating both temperature and duration of the ablation procedure (see Applicant’s specification: [0089]).
Claim Objections
Claim 8 is objected to because of the following informalities:
Regarding claim 8, the claim reads “automatically controlling, via the controller, the thermal energy source, the thermal fiber positioning device, and the MRI system during the thermal ablation the target tissue”. However, to be grammatically correct it should read “automatically controlling, via the controller, the thermal energy source, the thermal fiber positioning device, and the MRI system during the thermal ablation of the target tissue”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, and 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. US 2017/0100608 A1 “Wei” and further in view of Brannan US 2017/0319276 A1 “Brannan” and Shelton et al. US 2021/0038307 A1 “Shelton”.
Regarding claims 1 and 8, Wei teaches “A thermal ablation control system, comprising:” (Claim 1) (“FIG. 4 illustrates a block diagram of a thermal ablation system 400 according to one embodiment of the present invention. The HIFU therapeutic system 400 includes a thermal ablation apparatus 402 and a control apparatus 404. The thermal ablation apparatus 402 can be, but not limited to, RFA, microwave therapy, extracorporeal or direct focused ultrasound, and laser ablation” [0045]. Therefore, since the thermal ablation system 400 includes a control apparatus 404, the thermal ablation system 400 represents a thermal ablation control system.);
“A method of controlling a thermal ablation system, comprising:” (Claim 8) (“FIG. 5 illustrates a flow chart 500 for operating a thermal ablation system according to one embodiment of the present invention. FIG. 5 is described in combination with FIG. 1 and FIG. 4. At step 502, HIFU ablation is performed on a targeted tissue according to plan data of a treatment during a therapy mode of the HIFU therapeutic system. At step 504, T2* weighted MR imaging is performed for the targeted tissue to acquire a T2* weighted MR image during an assessment mode of the HIFU therapeutic system. At step 506, the therapeutic response of the HIFU ablation is assessed based upon the T2* weighted MR image during the assessment mode of the HIFU therapeutic system. At step 508, the HIFU therapeutic system is switched between the therapy mode and the assessment mode” [0050]. Therefore, since the method shown in FIG. 5 assesses whether to switch between therapy and assessment mode (see step 508) after assessing the therapeutic response of the HIFU ablation (see step 506), the method represents a method of controlling a thermal ablation system.);
“a controller comprising: a communication interface coupled to a thermal energy source, […], and a magnetic resonance imaging (MRI) system” (Claim 1); “at a controller coupled to a thermal energy source, […], and a magnetic resonance imaging (MRI) system” (Claim 8) (“The HIFU therapeutic system 400 includes a thermal ablation apparatus 402 and a control apparatus 404. The thermal ablation apparatus 402 can be, but not limited to, RFA, microwave therapy, extracorporeal or direct focused ultrasound, and laser ablation. In the embodiment of FIG. 4, for the purpose of description but not limitation, the HIFU therapeutic apparatus 402 is an MR-HIFU therapeutic apparatus including a therapeutic ultrasound apparatus 406 and a magnetic resonance apparatus 408. The control apparatus 404 has a hardware interface 410 that is for interfacing to external hardware. The hardware interface 408 is able to send and receive data. The hardware interface 410 has a sub-component which is an ultrasound control interface 412 connected to the therapeutic ultrasound apparatus 406. The hardware interface 408 also has a magnetic resonance control interface 414 connected to the magnetic resonance apparatus 408. The hardware interface 410 is connected to a microprocessor 416. The microprocessor 416 is representative of any processing unit able to perform instructions in order to control the HIFU therapeutic apparatus 402” [0045]. In this case, the control apparatus 404, represents a controller, which comprises a communication interface (i.e. hardware interface 410) coupled to a thermal energy source (i.e. ultrasound control interface 412/ultrasound apparatus 406) and a magnetic resonance imaging system (i.e. magnetic resonance control interface 414/magnetic resonance apparatus 408.); and
“processor to: monitor a magnetic resonance (MR) thermometry tissue temperature of the target tissue during the during thermal ablation of the target tissue” (Claim 1) and “activating the thermal ablation system via the controller; monitoring a magnetic resonance (MR) thermometry tissue temperature of the target tissue during thermal ablation of the target tissue” (Claim 8) (See microprocessor 416 in FIG. 4 and “Upon completion of the pretreatment procedure 102, the treatment procedure 104 in accordance with plan data starts. In the example of MR-HIFU therapy, a focused ultrasound beam is directed towards the targeted fibroids. The ultrasound beam is used for heating a tumor through the skin and intervening tissue while MR imaging is used for monitoring the temperature distribution within the insonified region. Using the proton resonance frequency shift (PRFS) method, the temperature in tissues having a high water content can be monitored accurately. A linear shift of the proton resonance frequency is observed for the range of temperatures being used in HIFU system. In this range, MR thermometry is also reasonably sensitive. The reconstruction of thermographic MR images during ultrasound therapy is useful to provide feedback to ensure that adequate heating is accomplished at the intended location while safeguarding that other critical anatomic structures are left intact” [0036]. The examiner respectfully notes that the method shown in FIG. 1, is used within the method shown in FIG. 5 (see [0050]). Therefore, since MR-HIFU therapy involves utilizing an ultrasound beam to heat a tumor and MR imaging to monitor the temperature distribution within the insonified region (i.e. MR thermometry), the system includes a processor (i.e. 416) configured to monitor a magnetic resonance (MR) thermometry tissue temperature of the target tissue (i.e. fibroids or tumors) during the thermal ablation of the target tissue. Additionally, the method carried out by the system involves activating the thermal ablation system (i.e. therapeutic ultrasound apparatus 406) via the controller (i.e. control apparatus 404); monitoring a magnetic resonance (MR) thermometry tissue temperature of the target tissue (i.e. fibroids or tumors) during the thermal ablation of the target tissue.);
“and automatically control functions of the thermal energy source, […], and the MRI system via the communication interface during the thermal ablation of the target tissue at least partially based on the MR thermometry tissue temperature of the target tissue monitored […]” (Claim 1); and “automatically controlling, via the controller, the thermal energy source, […] and the MRI system during the thermal ablation [of] the target tissue at least partially based on the MR thermometry tissue temperature of the target tissue […]” (Claim 8) (“During the therapy operations, the control module 422 is able to switch the HIFU therapeutic apparatus 402 between a therapy mode and an assessment mode. In the therapy mode, the therapeutic ultrasound apparatus is activated to perform HIFU ablation in accordance with plan data output from the treatment plan module 420. […] In the assessment mode, the therapeutic ultrasound apparatus 406 is deactivated to terminate HIFU ablation temporally. […] The treatment plan module 420 contains computer executable code which enables the microprocessor 426 to recognize the dark line margins of ablated volume automatically and therefore to assess the therapeutic response of HIFU ablation and modify the plan data in accordance with the assessment results. Upon completion of plan data modification, the HIFU therapeutic apparatus 402 is returned back to the therapy mode by activating the therapeutic ultrasound apparatus 406. Advantageously, the plan data of HIFU treatment can be modified repeatedly until a desirable assessment result is achieved to guarantee a successful HIFU ablation” [0047]. Therefore, since the control module 422 is able to switch the HIFU therapeutic apparatus 402 between therapy mode and assessment mode, and the microprocessor 426 is able to recognize the dark line margins of ablated volume automatically to assess therapeutic response and modify the plan data such that the HIFU therapeutic apparatus 402 can be returned back to the therapy mode to continue performing ablation, the processor is configured to automatically control functions of the thermal energy source (i.e. therapeutic ultrasound apparatus 406) and the MRI system (i.e. magnetic resonance apparatus 408) via the communication interface (i.e. hardware interface 410) during thermal ablation of a target tissue based on the MR thermometry tissue temperature at the ablation site and the user input values stored in the memory (see [0014] above). Additionally, the method involves automatically controlling, via the controller, the thermal energy source, […] and the MRI system during a thermal tissue ablation procedure based on the MR thermometry (see [0014]) tissue temperature at the ablation site.).
Wei does not teach “a memory to store, prior to thermal ablation of a target tissue, user input values defining elements of a thermal ablation procedure” (Claim 1); “receiving, prior to thermal ablation of a target tissue, user input values” (Claim 8); “a thermal fiber positioning device that moves a thermal fiber relative to an ablation site” (Claim 1); “a thermal fiber positioning device that moves a thermal fiber of the thermal ablation system relative to an ablation site” (Claim 8); “receive, via the communication interface, a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue at the ablation site, a non-target tissue type of a non-target tissue adjacent the target tissue at the ablation site, a necrotizing tissue temperature of the target tissue and a necrotizing tissue temperature of the non-target tissue” (Claim 1); “receiving, at the controller, a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue at the ablation site, a non-target tissue type of a non-target tissue adjacent the target tissue at the ablation site, a necrotizing tissue temperature of the target tissue, and a necrotizing tissue temperature of the non-target tissue” (Claim 8); ”monitor an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue” (Claim 1); “monitoring an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue” (Claim 8); or that automatically controlling the thermal energy source during the thermal ablation of the target tissue at least partially based on “the user input values stored in the memory” (Claim 1), “the MR thermometry tissue temperature of the non-target tissue, a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue” (Claims 1 and 8) and “the tissue damage model” (Claims 1 and 8).
Brannan is within the same field of endeavor as the claimed invention because it involves a microwave ablation system including a microwave ablation probe configured to deliver energy to a target volume of tissue during an ablation procedure and at least one temperature sensor (see [Abstract]).
Brannan teaches “a memory to store, prior to thermal ablation of a target tissue, user input values defining elements of a thermal ablation procedure” (Claim 1); “receiving, prior to thermal ablation of a target tissue, user input values” (Claim 8) (“At step 302, a user may use computing device 100 to load a treatment plan 400 (FIG. 4) into application 216. The treatment plan 400 (FIG. 4, described in more detail below) may include various treatment plans for an ablation procedure, a model of a patient's body, and/or a pathway to one or more targets. Then, at step 304, application 216, via user interface 218, displays instructions for setting up and configuring the microwave ablation system” [0041]; “Treatment plan 400 generally includes selection of a treatment best suited for a given ablation procedure based on the target's tissue type, the target's proximity to other tissue structures, the size of the target, and/or other characteristics of the target, patient, etc. […] Treatment plan 400 may include menus and/or sub-menus such that a user may select an appropriate treatment plan 400 for a given ablation procedure. More specifically, the selection of treatment plan 400 may include selecting a temperature accumulation profile 400A to plan and prepare for an ablation procedure. For example, if the target is located in a patient's liver, then a user would select the temperature accumulation profile 400A for the liver. […] However, the temperature accumulation profiles 400A are not limited to categorization based solely on the location; rather, temperature accumulation profiles 400A may be categorized or sub-categorized according to other characteristics of the target tissue, ablation zone size, proximity of the target to other tissue structures, behavior of the target and adjacent tissue structures when subjected to energy over time, characteristics of the patient, etc.” [0043].
In this case, in order for the user to select an appropriate treatment plan 400 such that it can be loaded into the application 216 (see FIG. 2) and carried out (see FIG. 3, steps 304-318), the memory (i.e. 202, see FIG. 2) must have been configured to store, prior to thermal ablation of a target tissue, user input values defining elements of a thermal ablation procedure.);
“receive, via the communication interface, a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue at the ablation site, a non-target tissue type of a non-target tissue adjacent the target tissue at the ablation site, a necrotizing tissue temperature of the target tissue and a necrotizing tissue temperature of the non-target tissue” (Claim 1); “receiving, at the controller, a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue at the ablation site, a non-target tissue type of a non-target tissue adjacent the target tissue at the ablation site, a necrotizing tissue temperature of the target tissue, and a necrotizing tissue temperature of the non-target tissue” (Claim 8) (See [0043] above and “Each temperature accumulation profile 400A provides a change in tissue temperature as a function of time that results in effective ablation of the target tissue (to which the temperature accumulation profile 400A corresponds) without damaging adjacent healthy tissue” [0044]; “Referring back to FIG. 1, temperature sensors TS may be utilized with treatment system 10 to constantly observe/monitor tissue temperatures in, or adjacent to, an ablation zone to enable implementation of temperature accumulation profiles 400A (FIG. 4A) and/or safety protocols 600 (FIG. 6)” [0050]. Thus, the temperature accumulation profile 400A effectively ablates the target tissue (i.e. liver, lung, kidney, for example) without damaging adjacent healthy tissue (i.e. non-target tissue). Additionally, the temperature sensors TS enable the implementation of the temperature accumulation profiles 400A and/or safety protocols, such that adjacent healthy tissue is not damaged. Since the user selects the temperature accumulation profile 400A corresponding to a desired ablation procedure (i.e. of the liver, lung, or kidney, for example), and the temperature accumulation profile 400A may be categorized/sub-categorized according to 1) characteristics of the target tissue, 2) the ablation zone size, 3) the proximity of the target to other tissue structures (i.e. non-target tissues), 4) behavior of the target and adjacent tissue structures when subjected to energy over time, and 5) characteristics of the patient, the temperature accumulation profile 400A represents a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue (i.e. liver, lung, or kidney, for example), a non-target tissue type of a non-target tissue adjacent the target tissue (i.e. other tissue structures, adjacent/healthy tissue), a necrotizing tissue temperature of the target tissue (i.e. corresponding to the temperature accumulation profile 400A) and a necrotizing tissue temperature of the non-target tissue (i.e. tissue temperature adjacent to the ablation zone, corresponding to safety protocols).);
”monitor an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue” (Claim 1); “monitoring an MR thermometry tissue temperature of the non-target tissue during the thermal ablation of the target tissue” (Claim 8) (“Referring back to FIG. 1, temperature sensors TS may be utilized with treatment system 10 to constantly observe/monitor tissue temperatures in, or adjacent to, an ablation zone to enable implementation of temperature accumulation profiles 400A (FIG. 4A) and/or safety protocols 600 (FIG. 6). For example, one or more temperature sensors TS may be provided on the ablation probe 130, e.g., adjacent the distal radiating section, and may be configured to measure tissue temperatures in or adjacent to an ablation zone. It should be appreciated that temperature sensors TS may be placed at any suitable location in treatment system 10 to provide temperature information, such as within a generator (not shown), catheters (not shown), proximal and/or distal radiating sections of ablation probe 130, the patient's body, or the like. As such, temperature sensors TS may be configured to provide a greater array of temperature data collection points and provide greater detail on tissue temperature during and/or following an application of energy from ablation probe 130. In an embodiment, temperature sensors TS may also be used to monitor impedance, which may be useful in predicting coagulum formation. Impedance monitoring may be correlated with temperature monitoring for quantitative tissue injury predictions. The temperature sensors TS may be, for example, a radiometer or thermocouple based system, a magnetic resonance imaging (MRI) thermometry system, or any other tissue temperature monitoring system known in the art” [0050].
Therefore, the temperature sensors TS (i.e. MRI thermometry system) is configured to observe/monitor tissue temperatures in, or adjacent to, an ablation zone during and/or following an application of energy from ablation probe 130. Tissues which are adjacent to an ablation zone (i.e. target tissue) include non-target tissue. Therefore, the one or more temperature sensors (TS) of Brannan are monitoring an MR thermometry tissue temperature of the target tissue and the non-target tissue (i.e. adjacent to the ablation zone), during the thermal ablation of the target tissue.);
that automatically controlling the system during the thermal tissue ablation procedure is based on “the user input values stored in the memory” (Claim 1), “the MR thermometry tissue temperature of the non-target tissue, a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue” (Claims 1 and 8) and “the tissue damage model” (Claims 1 and 8) (See [0043] and [0050] above and “While temperature accumulation profiles 400A of treatment plan 400 (see FIG. 4) are used to automatically adjust energy output, heating/cooling, etc. of the probe 130 (FIG. 1) to provide an appropriate thermal dosage over the course of an ablation procedure based on a treatment plan 400 selected, safety protocol 600 is configured to monitor and dynamically adjust energy output if a potentially tissue-damaging condition is detected” [0048]; “In an embodiment, screen 700 may provide a user with ultrasonic EM and/or infrared visualization of the target tissue, adjacent healthy tissue, such that thermal dosage and/or damage may be assessed to the tissue structures […] In an embodiment, display screen 700 may provide audio and/or visual feedback alerting a user to an unsafe condition. For example, screen 700 may indicate to a user that current ablation zone 718 and/or total ablation zone 720 is moving outside the target area in close proximity to other tissue structures and that an unsafe condition is imminent” [0053]. In this case, since the screen provides a visualization of the target tissue and adjacent healthy tissue such that thermal dosage/damage (i.e. in both the target and adjacent tissues) can be assessed, system had to have 1) monitored the MR thermometry tissue temperature of the non-target tissue, a 2) determined accumulated thermal energy (i.e. thermal dosage) absorbed by the non-target tissue during the thermal ablation of the target tissue.
Additionally, since the treatment plan 400 (i.e. one of the temperature accumulation profiles 400A, see FIG. 4) is used to automatically adjust energy output, heating/cooling, etc. of the probe 130 (FIG. 1) to provide an appropriate thermal dosage over the course of an ablation procedure selected (i.e. by user input), and the safety protocol 600 is configured to monitor and dynamically adjust energy output if a potentially tissue-damaging condition is detected” [0048], the method carried out by the system involves automatically controlling the thermal energy source/MRI system during the thermal ablation or the target tissue at least partially based on the MR thermometry tissue temperature of the non-target tissue, a determined accumulated thermal energy absorbed by the non-target tissue during the thermal ablation of the target tissue (i.e. thermal dosage in adjacent healthy tissue, see [0053]), wherein the temperature accumulation profile 400A (i.e. containing user input values) represents the tissue damage model stored in memory and which is selected by the user.).
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 thermal ablation control system and method of Wei such that the memory stored user input values defining elements of a thermal ablation procedure prior to thermal ablation of a target tissue and the processor receives a tissue damage model pre-calculated based on the user input values, the tissue damage model comprising a target tissue type of the target tissue (i.e. liver, lung, or kidney, for example), a non-target tissue type of a non-target tissue adjacent the target tissue (i.e. other tissue structures, adjacent/healthy tissue), a necrotizing tissue temperature of the target tissue (i.e. corresponding to the temperature accumulation profile 400A) and a necrotizing tissue temperature of the non-target tissue (i.e. tissue temperature adjacent to the ablation zone, corresponding to safety protocols, see Brannan: [0050]) as disclosed in Brannan in order to allow a user to select a treatment plan which will effectively ablate the target tissue without damaging adjacent healthy tissue. Utilizing a temperature accumulation profile 400A (see Brannan: FIG. 4, [0043]) is one of a finite number of techniques which can be used to allow a user to select a target tissue and corresponding treatment characteristics (i.e. ablation zone size, proximity to other tissue structures, behavior of the target and adjacent tissue when subjected to energy over time, etc., see [0043]) to effectively treat a target tissue, while minimizing damage to surrounding tissues with a reasonable expectation of success. Thus, modifying the thermal ablation control system and method of Wei to include receiving a tissue damage model (i.e. temperature accumulation profile 400A) as disclosed in Brannan would yield the predictable result of allowing a user to select an appropriate target tissue such that effective ablation can be provided thereto without damaging adjacent healthy tissue.
Wei in view of Brannan does not teach “a thermal fiber positioning device that moves a thermal fiber relative to an ablation site” (Claim 1); “a thermal fiber positioning device that moves a thermal fiber of the thermal ablation system relative to an ablation site” (Claim 8).
Shelton is within the same field of endeavor as the claimed invention because it involves utilizing a laser fiber to treat tissue (see [0078]).
Shelton teaches “a thermal fiber positioning device that moves a thermal fiber relative to an ablation site” (Claim 1); “a thermal fiber positioning device that moves a thermal fiber of the thermal ablation system relative to an ablation site” (Claim 8); (“The present laser sub-targeting without requiring moving of the guide device can also be used with medical treatment techniques other than lithotripsy, or for laser surgery or other uses involving targeted delivery of laser energy” [0077]; “In a tissue ablation example in which the target includes tissue to be ablated or coagulated, instead of a target stone, a desired spatiotemporal pattern can include providing fixed or variable energy, fixed or variable power, or fixed or variable wavelength laser energy from one or more laser sources such as in pulsatile, continuous wave, or other manner, such as to promote one or more of cutting or coagulation, or to balance or otherwise coordinate between these two or other objectives” [0078]. Therefore, the laser sub-targeting technique (described below) can be used to perform an ablation procedure.
Regarding the thermal fiber positioning device, Shelton discloses “An actuator 185 can be included, such as for example, can be located at or near the distal end of the endoscope, such as to actuate lateral positioning or re-positioning of a distal portion of the laser fiber 140 within and with respect to the longitudinal passage 145 of the distal portion 113 of the endoscope 110” [0053] and “In some examples, more than one actuators may be used to respectively actuate and control different motions of the laser fiber 140. FIG. 1G illustrates an example of the system 100 that comprises two separate actuators in the endoscope. In the example as illustrated therein, a first actuator 185A can control a longitudinal axial translation of the laser fiber 140, and a different second actuator 185B can control a lateral positioning of the laser fiber 140” [0066]. In this case, since the actuator 185 can be used to actuate lateral positioning of the distal portion of the laser fiber 140 and may include two separate actuators to cause longitudinal axial translation and lateral positioning of the laser fiber 140, the actuator 185 represents a thermal fiber positioning device which moves a thermal fiber relative to an ablation site.).
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 thermal ablation control system and method of Wei in view of Brannan to include the use of a thermal fiber positioning device as disclosed in Shelton in order to effectively deliver laser beams to a target region to induce ablation therein. Utilizing an actuator to move a laser fiber (i.e. thermal energy source) to a desired location (i.e. along axial and lateral positions, see Shelton: [0066]) is one of a finite number of techniques which can be used to effectively position the thermal energy source such that laser beams can be directed to the target area with a reasonable expectation of success. Furthermore, since the thermal ablation apparatus 402 of Wei can be used for laser ablation (see Wei: [0045]), it would be obvious to incorporate the actuator of Shelton into the thermal ablation system 400 of Wei in order to allow the laser fiber to be effectively positioned relative to the target tissue. Thus, modifying the thermal ablation control system and method of Wei in view of Brannan to include the use of a thermal fiber positioning device as disclosed in Shelton would yield the predictable result of effectively positioning the thermal energy source (i.e. laser source) for directing laser beams to a target tissue.
Regarding claims 2 and 9, Wei in view of Brannan and Shelton discloses all features of the claimed invention as discussed with respect to claims 1 and 8 above, and Shelton further teaches “wherein the thermal energy source is configured to output a laser energy having a wavelength, a power level, and a pulse frequency, and wherein the controller is configured to automatically control the wavelength, the power level, or the pulse frequency of the thermal energy source” (Claim 2) and “wherein automatically controlling the thermal energy source comprises controlling a wavelength, a power level, or a pulse frequency of a laser energy output of the thermal energy source” (Claim 9) (See [0078] as discussed in claims 1 and 8 above and “The controller circuit 120 can adjust laser settings of the laser source 130 using the one or more spectroscopic properties” [0067]; “The treatment beam 210 may include laser pulses of adjustable or variable energy” [0069]; “Variable energy and variable power can be used together or separately in a sequence of laser pulses such as can be delivered according to a desired spatiotemporal pattern to a target region” [0070]. Therefore, the thermal energy source (i.e. laser source 130), is configured to output a laser energy having a wavelength, a power level and a pulse frequency (i.e. pulsatile, continuous, etc., see [0078]). Furthermore, the controller is configured to automatically control the wavelength, the power level, or the pulse frequency of the laser energy output by the thermal energy source.).
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 thermal ablation control system and method of Wei in view of Brannan to include the use of a thermal energy source configured to output a laser energy having a wavelength, a power level and a pulse frequency and the controller being configured to automatically control the wavelength, the power level or the pulsed frequency of the thermal energy source as disclosed in Shelton in order to effectively deliver laser beams to a target region to induce ablation therein. Utilizing a controller circuit 120 to adjust laser settings such as energy and power is one of a finite number of techniques which can be used to effectively induce ablation within a target area with a reasonable expectation of success. Thus, modifying the thermal ablation control system and method of Wei to include the use of a thermal energy source configured to output a laser energy having a wavelength, a power level and a pulse frequency and a controller being configured to automatically control the wavelength, the power level or the pulsed frequency of the thermal energy source as disclosed in Shelton would yield the predictable result of effectively adjusting the laser energy output from the thermal energy source such that ablation can be effectively performed.
Regarding claims 3 and 10, Wei in view of Brannan and Shelton discloses all features of the claimed invention as discussed with respect to claims 1 and 8 above, and Shelton further teaches “wherein the thermal fiber positioning device comprises: an axial positioning mechanism that axially translates the thermal fiber proximally, and distally during the thermal ablation procedure; and a directionality mechanism that directs a distal end of the thermal fiber in an angular direction relative to a longitudinal axis of the thermal fiber, wherein the controller is configured to automatically control the axial positioning mechanism and the directionality mechanism” (Claim 3) and “wherein automatically controlling the thermal fiber positioning device comprises: controlling an axial positioning mechanism that axially translates the thermal fiber proximally and distally during the thermal tissue ablation procedure; and controlling a directionality mechanism that directs a distal end of the thermal fiber in an angular direction relative to a longitudinal axis of the thermal fiber“ (Claim 10) (See [0066] as discussed with respect to claims 1 and 8 above and “Additionally or alternatively, the actuator 185 may optionally include bending actuation capability, such as to adjust the bend of the distal portion of the laser fiber 140 for sub-targeting, such as electromagnetically, electrostatically, piezoelectrically, or otherwise such as explained herein” [0064]. Therefore, the thermal fiber positioning device (i.e. actuator) comprises an axial positioning mechanism (i.e. 185A, see FIG. 1G) and a directionality mechanism (i.e. 185B, see FIG. 1G; for bending, [0064]).
Additionally, Shelton discloses “FIG. 1H and 1I illustrate examples of the system 100 that uses a feedback signal reflected from the target to control and adjust the position of the laser fiber 140 with respect to a distal end of the endoscope 110. The feedback signal may be produced in response to electromagnetic radiation of the target (e.g., the light 170). […] The controller circuitry 120 can control the actuator 185 to adjust the position of the fiber distal end based on the calculated distance between the distal end of the laser fiber 140 and the target. For example, if the calculated distance exceeds a desired laser firing range (within a specified margin), then the controller circuitry 120 may generate a control signal to the control the actuator 185 to slide the laser fiber 140 towards the target until the fiber distal end reaches within the laser firing range with respect to the target. In some examples, spectroscopic information of the target from the feedback analyzer 182 may be used by the controller circuitry 120 to determine movement and position of laser fiber 140 via the actuator 185” [0067]. Therefore, since the system 100 can receive a feedback signal from the target and use it to control and adjust the position of the laser fiber 140, via the controller circuitry 120 controlling the actuator 185, the controller is configured to automatically control the axial positioning mechanism that axially translates the thermal fiber proximally and distally during the thermal ablation of the target tissue and the directionality mechanism that directs a distal end of the thermal fiber in an angular direction relative to a longitudinal axis of the thermal fiber.).
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 thermal ablation control system and method of Wei in view of Brannan to include the use of a thermal