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 .
Response to Amendment
The amendment filed January 5th, 2026 has been entered. Claims 1, 3, 16, 21, & 22 are amended. Claims 1-25 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a plurality of one or more sensors”; it is unclear how there can be a plurality of one or more sensors; more specifically, if there is only one sensor it is unclear how there can be a plurality of one sensor, which renders the claim indefinite. For examination purposes the examiner is considering “a plurality of one or more sensors” to be –one or more sensors—. Dependent claims 2-15 are rejected by virtue of their dependency on independent claim 1.
Claim 16 recites the limitation “a plurality of one or more sensors”; it is unclear how there can be a plurality of one or more sensors; more specifically, if there is only one sensor it is unclear how there can be a plurality of one sensor, which renders the claim indefinite. For examination purposes the examiner is considering “a plurality of one or more sensors” to be –one or more sensors—. Dependent claims 17-20 are rejected by virtue of their dependency on independent claim 16.
Claim 21 recites the limitation “a plurality of one or more sensors”; it is unclear how there can be a plurality of one or more sensors; more specifically, if there is only one sensor it is unclear how there can be a plurality of one sensor, which renders the claim indefinite. For examination purposes the examiner is considering “a plurality of one or more sensors” to be –one or more sensors—. Dependent claims 22-25 are rejected by virtue of their dependency on independent claim 21.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 15, 21-23, & 25 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (previously presented-US 20210282835 A1), hereinafter “Condie”, in view of Dickhans et al. (US 20160051221 A1), hereinafter “Dickhans”.
Regarding claim 1, as best understood in view of the 112(b) rejection above, Condie discloses a microwave ablation apparatus comprising: a base unit ([0061]; Figure 1A—element 102) comprising at least one microwave generator ([0067]; Figure 1A—element 130) and at least one coolant flow generator ([0065]; Figure 1A—element 140); and an operating platform coupled to a processor and memory ([0061] & [0068]; Figure 1A—element 106), the operating platform configured to: receive ablation zone inputs corresponding to desired characteristics of an ablation zone ([0170]; Figure 8—element 810; the system may determine ablation procedure parameters (e.g. target area dimensions, the positioning of the one or more ablation devices, ablation duration, and amount of energy)); operate the at least one microwave generator to form the ablation zone with the desired characteristics ([0171]; Figure 8—element 820; after determining ablation procedure parameters the ablation system may initiate delivering ablation power to the target area); obtain measurement information from a plurality of one or more sensors ([0078], [0175], & [0178]).
Condie does not disclose based on the measurement information, determine that the ablation zone with the desired characteristics has not been achieved; in response to the determination, adjust one or more operating parameters of the operating platform; and operate the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics.
Dickhans teaches a microwave ablation apparatus ([0030] & [0033]; Figure 1—element 60) comprising an operating platform configured to receive ablation zone inputs ([0032], & [0034], & [0070]; Figure 1—element 125; Figure 6—element 609), operate a microwave generator to form the ablation zone with the desired characteristics ([0071] & [0073]; Figure 6—element 610; Figure 7—element 701); obtain measurement information from a plurality of one or more sensors ([0068] & [0073]; Figure 7—element 703); based on the measurement information, determine that the ablation zone with the desired characteristics has not been achieved ([0074]; Figure 7—elements 705 & 707; based on the measurement information a determination is made as to whether the entire target has been ablated to determine if further ablation or application of energy is needed); in response to the determination, adjust one or more operating parameters of the operating platform; and operate the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics ([0053] & [0074]; Figure 7—element 708; the entire target has not been ablated additional microwave energy is applied, particularly, feedback from the sensors are used to determine an appropriate ablation dose (including power level or duration of application of energy) to apply to assist in ensuring that the entire target tissue will be ablated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the operating platform, as disclosed by Condie, to include the operating platform configured to, based on the measurement information, determine that the ablation zone with the desired characteristics has not been achieved, adjust one or more operating parameters of the operating platform, and operate the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics, as taught by Dickhans, as both references and the claimed invention are directed toward microwave ablation devices. As disclosed by Condie, measurement information obtained from one or more sensors throughout the ablation procedure may be used to determine the quality of the ablation ([0075], [0175], & [0178]). As disclosed by Dickhans, measurement information obtained from one or more sensors during that ablation procedure may be used to determine whether or not the target has been fully ablated, if the target has not been fully ablated additional microwave energy may be applied and the feedback from the sensors may be used to determine an appropriate ablation dose (power level, duration of application of energy) to further apply to the target in order to ensure the entire target tissue will be ablated, using these methodologies allows a user to monitor and confirm treatment of tissue ([0028] & [0074]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the operating platform, as disclosed by Condie, to include the operating platform configured to, based on the measurement information, determine that the ablation zone with the desired characteristics has not been achieved, adjust one or more operating parameters of the operating platform, and operate the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics, as taught by Dickhans, as such a modification would allow for the operating platform to determine if the entire target tissue has been ablated or if additional microwave energy is needed in order to ensure the entire target tissue will be ablated while also allowing the user to monitor and confirm treatment of the tissue.
Regarding claim 2, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie further discloses wherein the ablation zone inputs are received from a needle user interface ([0061], [0170], & [0183]; Figure 1A—element 104; Figure 9—element 900; the ablation procedure parameters may be received as inputs via the user interface 104/900).
Regarding claim 3, Condie in view of Dickhans disclose all of the limitations of claim 2, as described above.
Condie further discloses wherein the needle user interface comprises at least one ablation zone adjustor configured to allow a user to adjust the desired characteristics of the ablation zone ([0183]; Figure 9—element 940).
Regarding claim 4, Condie in view of Dickhans disclose all of the limitations of claim 3, as described above.
Condie further discloses wherein the needle user interface comprises a graphical illustration of the ablation zone that dynamically changes as the user changes the desired characteristics using the at least one ablation zone adjustor ([0182] & [0183]; Figure 9—element 930).
Regarding claim 5, Condie in view of Dickhans disclose all of the limitations of claim 2, as described above.
Condie further discloses wherein the needle user interface comprises a timer indicating a length of time of an ablation cycle and a power indicator indicating a power of the power signal delivered from the at least one microwave generator ([0180]-[0184]; Figure 9—elements 910, 915, & 920) .
Regarding claim 6, Condie in view of Dickhans disclose all of the limitations of claim 2, as described above.
Condie further discloses wherein the needle user interface comprises a single needle user interface configured to display the ablation zone of a single needle ([0062]-[0064], [0170], [0182], & [0183]; Figure 1A—elements 120; Figure 9—element 930; the console is configured to interface with and operate one ablation device and the GUI 900 is configured to display 930 the position of the target area relative to the ablation device).
Regarding claim 7, Condie in view of Dickhans disclose all of the limitations of claim 2, as described above.
Condie further discloses wherein the needle user interface comprises a linked needle user interface configured to display the ablation zone formed by two needle operating together ([0062]-[0064], [0170], [0182], & [0183]; Figure 1A—elements 120; Figure 9—element 930; the console is configured to interface with and operate two ablation device simultaneously and the GUI 900 is configured to display 930 the position of the target area relative to the ablation devices).
Regarding claim 8, Condie in view of Dickhans disclose all of the limitations of claim 2, as described above.
Condie further discloses wherein the needle user interface comprises an independent needle user interface configured to display a first ablation zone and a second ablation zone, the first ablation zone formed by a first needle and the second ablation zone formed by a second needle operated independently from the first needle ([0062]-[0064], [0156], [0170], [0182], & [0183]; Figure 1A—elements 120; Figure 9—element 930; the console is configured to interface with and operate two ablation device individually and the GUI 900 is configured to display 930 the position of the target area relative to the ablation devices).
Regarding claim 9, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie further discloses wherein the operating platform is further configured to operate the at least one coolant flow generator to cause a flow of coolant to move through an ablation probe assembly ([0171]).
Regarding claim 15, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie further discloses wherein the operating platform is configured to perform a track ablate procedure after receiving an input from a user on a needle user interface ([0175]-[0179]; Figure 8—elements 830 & 880).
Regarding method claim 21, as best understood in view of the 112(b) rejection above, Condie discloses a method of forming an ablation zone using an ablation probe comprising: obtaining needle information characterizing one or more characteristics of the needle of the ablation probe ([0168] & [0170]; Figure 7—element 770; Figure 8—element 810; information about the ablation device’s condition may be provides and ablation procedure parameters may be determined including the geometry of the ablation device being used); displaying a needle user interface comprising one or more ablation zone adjustors ([0170], & [0183]-[0184]; Figure 9—elements 900 & 940; the graphic user interface may receive inputs regarding the ablation procedure parameters (e.g. the diameter of the target area), the parameters may be adjustable parameters 940); receiving at least one ablation zone input via the one or more ablation zone adjustors ([0170]; Figure 8—element 810), the at least one ablation zone input corresponding to at least one characteristic of a desired ablation zone ([0170]; Figure 8—element 810; the system may determine ablation procedure parameters (e.g. target area dimensions, the positioning of the one or more ablation devices, ablation duration, and amount of energy)); operating a microwave generator to form the desired ablation zone having the at least one characteristic ([0171]; Figure 8—element 820); obtaining measurement information from a plurality of one or more sensors ([0078], [0175], & [0178]).
Condie does not disclose based on the measurement information, determining that the desired ablation zone having the at least one characteristic has not been achieved; in response to the determination, adjusting one or more operating parameters; and operating the microwave generator with the adjusted one or more operating parameters to form the desired ablation zone having the at least one characteristic.
Dickhans teaches a method of forming an ablation comprising receiving at least one ablation zone input, the at least one ablation zone input corresponding to at least one characteristic of a desired ablation zone ([0034] & [0070]; Figure 6—element 609), operating a microwave generator to form the desired ablation zone having the at least one characteristic ([0071] & [0073]; Figure 6—element 610; Figure 7—element 701); obtaining measurement information from a plurality of one or more sensors ([0068] & [0073]; Figure 7—element 703); based on the measurement information, determining that the desired ablation zone having the at least one characteristic has not been achieved ([0074]; Figure 7—elements 705 & 707; based on the measurement information a determination is made as to whether the entire target has been ablated to determine if further ablation or application of energy is needed); in response to the determination, adjusting one or more operating parameters; and operating the microwave generator with the adjusted one or more operating parameters to form the desired ablation zone having the at least one characteristic ([0053] & [0074]; Figure 7—element 708; the entire target has not been ablated additional microwave energy is applied, particularly, feedback from the sensors are used to determine an appropriate ablation dose (including power level or duration of application of energy) to apply to assist in ensuring that the entire target tissue will be ablated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of forming an ablation zone, as disclosed by Condie, to include the method of forming an ablation zone comprising, based on the measurement information, determining that the desired ablation zone having the at least one characteristic has not been achieved, adjusting one or more operating parameters, and operating the microwave generator with the adjusted one or more operating parameters to form the desired ablation zone having the at least one characteristic, as taught by Dickhans, as both references and the claimed invention are directed toward microwave ablation methods. As disclosed by Condie, measurement information obtained from one or more sensors throughout the ablation procedure may be used to determine the quality of the ablation ([0075], [0175], & [0178]). As disclosed by Dickhans, measurement information obtained from one or more sensors during that ablation procedure may be used to determine whether or not the target has been fully ablated, if the target has not been fully ablated additional microwave energy may be applied and the feedback from the sensors may be used to determine an appropriate ablation dose (power level, duration of application of energy) to further apply to the target in order to ensure the entire target tissue will be ablated, using these methodologies allows a user to monitor and confirm treatment of tissue ([0028] & [0074]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of forming an ablation zone, as disclosed by Condie, to include the method of forming an ablation zone comprising, based on the measurement information, determining that the desired ablation zone having the at least one characteristic has not been achieved, adjusting one or more operating parameters, and operating the microwave generator with the adjusted one or more operating parameters to form the desired ablation zone having the at least one characteristic, as taught by Dickhans, as such a modification would determine if the entire target tissue has been ablated or if additional microwave energy is needed in order to ensure the entire target tissue will be ablated while also allowing the user to monitor and confirm treatment of the tissue.
Regarding method claim 22, Condie in view of Dickhans disclose all of the limitations of claim 21, as described above.
Condie further discloses wherein the needle user interface comprises an illustration of the ablation zone ([0182] & [0183]; Figure 9—elements 930 & 940).
Regarding method claim 23, Condie in view of Dickhans disclose all of the limitations of claim 22, as described above.
Condie further discloses wherein the illustration of the ablation zone dynamically changes when the one or more ablation zone adjustors are changed ([0182] & [0183]; Figure 9—elements 930 & 940).
Regarding method claim 25, Condie in view of Dickhans disclose all of the limitations of claim 21, as described above.
Condie further discloses wherein the needle user interface comprises a track ablate selector configured to cause a track ablate procedure to be performed when selected ([0172], [0178], [0180]; Figure 8—elements 830 & 880; Figure 9—elements 910 & 920).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Dickhans and Laubenthal et al. (previously presented-US 20190117322 A1), hereinafter “Laubenthal”.
Regarding claims 10-12, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie further discloses wherein the base unit comprises a cassette receptacle and a probe receptacle ([0061], [0062], [0067], [0069], [0087] & [0088]; Figure 1A—element 108; Figure 2) (claim 11); further comprising an ablation probe assembly removably coupled to the base unit ([0062] & [0087]; Figure 1A—element 120)(claim 12).
Condie does not disclose wherein the base unit comprises a panel positioned proximate the receptacles, wherein the operating platform is configured to display at least one indicator on the panel to identify the cassette receptacle and the probe receptacle (claim 10); wherein the base unit comprises a cassette light positioned at the cassette receptacle and a probe light positioned at the probe receptacle, and the operating platform is configured to display a color with the cassette light and the probe light that corresponds to the at least one indicator on the panel (claim 11); a cable assembly light, wherein the operating platform is further configured to display the color with the cable assembly light that corresponds to the color displayed on the panel, the cassette light, and the probe light (claim 12).
Laubenthal teaches a base unit ([0041]; Figure 1—element 32) comprising receptacles ([0040] & [0043]; Figure 1—elements 56 & 64), wherein the base unit comprises a panel positioned proximate the receptacles ([0042]; Figure 1—element 72), wherein the operating platform is configured to display at least one indicator on the panel to identify the cassette receptacle and the probe receptacle ([0043], [0049], [0053], [0068]; Figures 1 & 13—elements 74 & 80) (claim 10); wherein the base unit comprises a cassette light positioned at the cassette receptacle ([0049] & [0057]; Figures 13 & 14—element 64 & 162) and a probe light positioned at the probe receptacle ([0049] & [0053]; Figures 13 & 14—elements 56 & 80), and the operating platform is configured to display a color with the cassette light and the probe light that corresponds to the at least one indicator on the panel ([0068]; Figures 13 & 14; the LEDs may emit a colored light that matches the colored light emitted by the other indicators and lights) (claim 11); a cable assembly light, wherein the operating platform is further configured to display the color with the cable assembly light that corresponds to the color displayed on the panel, the cassette light, and the probe light ([0068], [0071], & [0073]; Figures 1—element 22 & 80; the surgical instrument 22 may comprise a visual indicator 80 that may emit a colored light to match the colored light of the other visual indicators) (claim 12).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the operating platform, the cassette receptacle, the probe receptacle, and the ablation probe assembly, as disclosed by Condie, to include a panel configured to display at least one indicator, wherein the receptacles and the ablation probe assembly each comprising a light that corresponds to the at least one indicator on the panel, as taught by Laubenthal, as both references and the claimed invention are directed toward electrosurgical consoles for receiving instruments and providing feedback to a user. As disclosed by Laubenthal, by providing a panel and visual indicators disposed on the panel, receptacles, and surgical devices the indicators can provide feedback to the user regarding the instruments, input devices, and their association with one another ([0003] & [0049]). 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 operating platform, the cassette receptacle, the probe receptacle, and the ablation probe assembly, as disclosed by Condie, to include a panel configured to display at least one indicator, wherein the receptacles and the ablation probe assembly each comprising a light that corresponds to the at least one indicator on the panel, as taught by Laubenthal, as such a modification would provide a user visual feedback regarding the instrument, input devices, and their association with one another.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Dickhans and Shikhman (previously presented-US 20110112529 A1), hereinafter “Shikhman”.
Regarding claim 13, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie does not disclose wherein the operating platform is configured to guide a user to connect a cassette to the base unit and connect an ablation probe to the base unit.
Shikhman teaches an operating platform comprising a base station, wherein the operating platform is configured to guide a user to connect a cassette to the base unit and connect an ablation probe to the base unit ([0078]; Figure 11—element 500; the GUI may display an array of SETUP prompts that leads the operator in a step-wise fashion through the tasks required to enable use of the generator and the device; the physician is guided to couple the source of cooling liquid and the treatment device to the appropriate port).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the operating platform, as disclosed by Condie, to further include wherein the operating platform is configured to guide a user to connect a cassette to the base unit and connect an ablation probe to the base unit, as taught by Shikhman, as both references and the claimed invention are directed toward ablation systems comprising user interfaces to guide ablation. As disclosed by Shikhman, the operating platform may implement a set up function that displays prompts which leads the operator in a step-wise fashion through the tasks required to enable use of the generator and the device, including coupling a source of cooling liquid and coupling the selected treatment device ([0078]). 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 operating platform, as disclosed by Condie, to further include wherein the operating platform is configured to guide a user to connect a cassette to the base unit and connect an ablation probe to the base unit, as taught by Shikhman, as such a modification would provide additional feedback to a user regarding the set up and the tasks required to enable use of the generator and the device.
Claims 14 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Dickhans and Condie et al. (previously presented-US 20210212763 A1), hereinafter “Condie763”.
Regarding claim 14, Condie in view of Dickhans disclose all of the limitations of claim 1, as described above.
Condie does not disclose wherein the operating platform is configured to perform a needle lock procedure after receiving an input from a user on a needle user interface.
Condie763 teaches an operating platform configured to receive receiving an input from a user on a needle user interface ([0066]; Figure 1A—element 104), wherein the operating platform is configured to perform a needle lock procedure after receiving an input from a user on a needle user interface ([0185]-[0189]; Figure 8).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the operating platform, as disclosed by Condie, to include wherein the operating platform is configured to perform a needle lock procedure after receiving an input from a user on a needle user interface, as taught by Condie763, as both references and the claimed invention are directed toward ablation systems comprising coolant flow generators and needles. As disclosed by Condie763, a stick mode ablation process may be carried out in response to an input from a user, the stick mode ablation process causes adhesion of the needle to tissue to hold the needle in place against accidental movement and produces a narrow ablation zone that does not damage excess tissue beyond what is intended for ablation ([0168], [0173], & [0185]). 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 operating platform, as disclosed by Condie, to include wherein the operating platform is configured to perform a needle lock procedure after receiving an input from a user on a needle user interface, as taught by Condie763, as such a modification would provide for a process that holds the needle in place against accidental movement and does not damage excess tissue beyond what is intended for ablation.
Regarding method claim 24, Condie in view of Dickhans disclose all of the limitations of claim 21, as described above.
Condie does not disclose wherein the needle user interface comprises a needle lock selector configured to cause a needle lock procedure to be performed when selected.
Condie763 teaches a method of ablating tissue comprising a needle user interface ([0066]; Figure 1A—element 104), wherein the needle user interface comprises a needle lock selector configured to cause a needle lock procedure to be performed when selected ([0185]-[0189]; Figure 8).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the needle user interface, as disclosed by Condie, to include wherein the needle user interface comprises a needle lock selector configured to cause a needle lock procedure to be performed when selected, as taught by Condie763, as both references and the claimed invention are directed toward ablation methods. As disclosed by Condie763, a stick mode ablation process may be carried out in response to an input from a user, the stick mode ablation process causes adhesion of the needle to tissue to hold the needle in place against accidental movement and produces a narrow ablation zone that does not damage excess tissue beyond what is intended for ablation ([0168], [0173], & [0185]). 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 needle user interface, as disclosed by Condie, to include wherein the needle user interface comprises a needle lock selector configured to cause a needle lock procedure to be performed when selected, as taught by Condie763, as such a modification would provide for a process that holds the needle in place against accidental movement and does not damage excess tissue beyond what is intended for ablation.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Cavanagh et al. (US 20250000607 A1), hereinafter “Cavanagh”, and Dickhans.
Regarding method claim 16, as best understood in view of the 112(b) rejection above, Condie discloses a method of guiding a user to set-up an ablation apparatus comprising: a cassette ([0065], [0070], [0085], [0089], & [0090]; Figures 1A & 1B—element 140; Figure 2—elements 218, & 220/226) into a base unit of an ablation apparatus ([0061] & [0089]; Figure 1A—element 102); a probe connector into the base unit of the ablation apparatus, the probe connector coupled to an ablation probe assembly ([0062] & [0087]-[0088]; Figure 1A—element 120; Figure 2—element 202); receiving ablation zone inputs corresponding to desired characteristics of an ablation zone ([0170]; Figure 8—element 810; the system may determine ablation procedure parameters (e.g. target area dimensions, the positioning of the one or more ablation devices, ablation duration, and amount of energy)); operating at least one microwave generator to form an ablation zone with the desired characteristics ([0171]; Figure 8—element 820; after determining ablation procedure parameters the ablation system may initiate delivering ablation power to the target area); obtaining measurement information from a plurality of one or more sensors ([0078], [0175], & [0178]).
Condie does not disclose displaying a first user interface instructing a user to insert a cassette into a base unit; displaying a second user interface instructing the user to insert a probe connector into the base unit; comparing probe information obtained from the ablation probe assembly to predetermined probe information; and displaying a third user interface instructing the user that the ablation apparatus is ready for use; based on the measurement information, determining that the ablation zone with the desired characteristics has not been achieved; in response to the determination, adjusting one or more operating parameters of the operating platform; and operating the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics.
Cavanagh discloses a method of guiding a user to set-up an apparatus comprising: displaying a first user interface instructing a user to insert a cassette into a base unit ([0123], [0124], & [0125]; Figure 15C—element 560); displaying a second user interface instructing the user to insert a probe connector into the base unit ([0127]-[0128]; Figures 15G & 15H); comparing probe information obtained from the probe assembly to predetermined probe information ([0131]; the probe may comprise a unique identifier (e.g. bar code, chip, etc.) which allows for identification of the probe assembly by the system, such that a user may confirm that the appropriate probe is attached); displaying a third user interface instructing the user that the apparatus is ready for use ([0124], & [0129]-[0130]; Figure 15J; once each of the initialization tasks has been completed, the GUI will provide the user with the status of each task and will prompt the user to calibrate the device).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of guiding the user to set-up the ablation apparatus, as disclosed by Condie, to include the method of guiding the user to set-up the apparatus comprising displaying a first user interface instructing a user to insert a cassette into a base unit, displaying a second user interface instructing the user to insert a probe connector into the base unit, comparing probe information obtained from the probe assembly to predetermined probe information, and displaying a third user interface instructing the user that the apparatus is ready for use, as taught by Cavanagh, as both references and the claimed invention are directed toward surgical systems comprising base stations with releasably coupled surgical devices and user interfaces to guide a user through a surgical procedure. As disclosed by Condie, the coolant supply and return lines may be releasably coupled to the base station and the ablation probe may be releasably coupled to the base station; a pre-ablation procedure may take place in order to ensure the system is working properly and information may be provided to the user via a graphical user interface ([0087]-[0090], [0160], & [0168]). As disclosed by Cavanagh, an initialization process may take place prior to the operation of the device, the graphical user interface may guide the user through the initialization process of the device by displaying the status of a plurality of initialization tasks required prior to the operation of the device, for example the GUI may instruct the user to install the cassette, connect the probe, and prompt the user to calibrate the device once the necessary tasks are indicated as being successfully completed, the initialization process and the calibration ensure appropriate operation of the device ([0124]-[0131]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of guiding the user to set-up the ablation apparatus, as disclosed by Condie, to include the method of guiding the user to set-up the apparatus comprising displaying a first user interface instructing a user to insert a cassette into a base unit, displaying a second user interface instructing the user to insert a probe connector into the base unit, comparing probe information obtained from the probe assembly to predetermined probe information, and displaying a third user interface instructing the user that the apparatus is ready for use, as taught by Cavanagh, as such a modification would produce the predictable result of ensuring appropriate operation of the device, while also aiding in guiding the user in an initialization of device that would further provide feedback to the user regarding whether or not the cassette and probe are successfully connected to the base station.
Dickhans teaches a method of ablating tissue comprising receiving ablation zone inputs corresponding to a desired characteristics of an ablation zone ([0034] & [0070]; Figure 6—element 609), operating a microwave generator to form the desired ablation zone with the desired characteristics ([0071] & [0073]; Figure 6—element 610; Figure 7—element 701); obtaining measurement information from a plurality of one or more sensors ([0068] & [0073]; Figure 7—element 703); based on the measurement information, determining that the ablation zone with the desired characteristics has not been achieved ([0074]; Figure 7—elements 705 & 707; based on the measurement information a determination is made as to whether the entire target has been ablated to determine if further ablation or application of energy is needed); in response to the determination, adjusting one or more operating parameters of the operating platform; and operating the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics ([0053] & [0074]; Figure 7—element 708; the entire target has not been ablated additional microwave energy is applied, particularly, feedback from the sensors are used to determine an appropriate ablation dose (including power level or duration of application of energy) to apply to assist in ensuring that the entire target tissue will be ablated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method ablating tissue, as disclosed by Condie, to include the method ablating tissue comprising, based on the measurement information, determining that the ablation zone with the desired characteristics has not been achieved, adjusting one or more operating parameters of the operating platform, and operating the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics, as taught by Dickhans, as both references and the claimed invention are directed toward microwave ablation methods. As disclosed by Condie, measurement information obtained from one or more sensors throughout the ablation procedure may be used to determine the quality of the ablation ([0075], [0175], & [0178]). As disclosed by Dickhans, measurement information obtained from one or more sensors during that ablation procedure may be used to determine whether or not the target has been fully ablated, if the target has not been fully ablated additional microwave energy may be applied and the feedback from the sensors may be used to determine an appropriate ablation dose (power level, duration of application of energy) to further apply to the target in order to ensure the entire target tissue will be ablated, using these methodologies allows a user to monitor and confirm treatment of tissue ([0028] & [0074]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method ablating tissue, as disclosed by Condie, to include the method ablating tissue comprising, based on the measurement information, determining that the ablation zone with the desired characteristics has not been achieved, adjusting one or more operating parameters of the operating platform, and operating the at least one microwave generator with the adjusted one or more operating parameters to form the ablation zone with the desired characteristics, as taught by Dickhans, as such a modification would determine if the entire target tissue has been ablated or if additional microwave energy is needed in order to ensure the entire target tissue will be ablated while also allowing the user to monitor and confirm treatment of the tissue.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Cavanagh, Dickhans, and Laubenthal.
Regarding method claims 17-20, Condie in view of Cavanagh and Dickhans disclose all of the limitations of claim 16, as described above.
Condie does not disclose displaying an indicator on a panel of the base unit to identify the ablation probe assembly (claim 17); displaying the indicator at a cassette receptacle to identify a correct location of insertion of the cassette (claim 18); displaying the indicator at a probe receptacle to identify a correct location of insertion of the probe connector (claim 19); displaying the indicator on the ablation probe assembly (claim 20).
Laubenthal teaches a method of operating a base unit ([0041]; Figure 1—element 32) comprising receptacles ([0040] & [0043]; Figure 1—elements 56 & 64), displaying an indicator on a panel of the base unit to identify the ablation probe assembly ([0043], [0049], [0053], [0068]; Figures 1 & 13—elements 74 & 80) (claim 17); displaying the indicator at a cassette receptacle to identify a correct location of insertion of the cassette ([0049] & [0057]; Figures 13 & 14—element 64 & 162) (claim 18); displaying the indicator at a probe receptacle to identify a correct location of insertion of the probe connector ([0049] & [0053]; Figures 13 & 14—elements 56 & 80) (claim 19); displaying the indicator on the ablation probe assembly ([0068], [0071], & [0073]; Figures 1—element 22 & 80; the surgical instrument 22 may comprise a visual indicator 80 that may emit a colored light to match the colored light of the other visual indicators) (claim 20).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of operating the base station, as disclosed by Condie, to include displaying an indicator on a panel of the base unit to identify the ablation probe assembly, displaying the indicator at a cassette receptacle to identify a correct location of insertion of the cassette, displaying the indicator at a probe receptacle to identify a correct location of insertion of the probe connector, and displaying the indicator on the ablation probe assembly, as taught by Laubenthal, as both references and the claimed invention are directed toward methods of operating electrosurgical consoles that are configured to receive instruments and providing feedback to a user. As disclosed by Laubenthal, by providing a panel and visual indicators disposed on the panel, receptacles, and surgical devices the indicators can provide feedback to the user regarding the instruments, input devices, and their association with one another ([0003] & [0049]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of operating the base station, as disclosed by Condie, to include displaying an indicator on a panel of the base unit to identify the ablation probe assembly, displaying the indicator at a cassette receptacle to identify a correct location of insertion of the cassette, displaying the indicator at a probe receptacle to identify a correct location of insertion of the probe connector, and displaying the indicator on the ablation probe assembly, as taught by Laubenthal, as such a modification would provide a user visual feedback regarding the instrument, input devices, and their association with one another.
Conclusion
Accordingly, claims 1-25 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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