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 .
Claims 1-10, 12, and 31-34 are cancelled. A complete action on the merits of pending claims 11, 13-30, and 35-37 appears herein.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues “The Office action relies on Chu for allegedly teaching the target dose. However, Chu does not disclose delivering a total energy dose absorbed by the uterine tissue that is distinct from the energy delivered to the device. In contrast, Chu describes a procedural workflow in which the clinician simply repositions the microwave antenna until the entire uterine cavity has been ablated (para. [0121]). Chu is focused on spatial coverage of the uterine cavity through sequential ablation zones, not delivery of a predetermined or calculated total absorbed energy dose. In Chu, the ablation is endpoint-driven (i.e., the procedure continues until visual or positional criteria indicate the cavity has been fully treated), rather than dose-driven as claimed. Nowhere does Chu quantify, regulate, or monitor the absorbed energy in the uterine tissue, nor does Chu distinguish between (1) the energy emitted from the source to the antenna and (2) the actual energy absorbed by tissue. The amended claims require determining and delivering a specific total absorbed energy dose, which is different from simply energizing an antenna at multiple positions until the cavity appears fully ablated. Thus, Chu neither teaches nor suggests the claimed dose-based control paradigm. Haley and Edwards do not cure the deficiencies of Chu.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, applicant's arguments regarding prior art references Haley and Edwards fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Examiner respectfully disagrees with Applicant’s arguments and contends that Chu teaches ablating a plurality of tissue locations during an ablation procedure (Par. [0121]) and automatically adjusting a delivered energy dose based on a feedback loop during ablation. (Par. [0112]) Haley, as further discussed in the rejection to claims 11, 20, and 28 below, teaches delivering a total energy dose absorbed by the target tissue that is distinct from the energy delivered to the device. (Par. [0022]: the measured return power would represent a loss during energy delivery, meaning that not all the energy delivered to the device was absorbed by the target tissue.)
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11, 13-16, 20-23, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2010/0121319 A1), in view of Haley (US 2010/0082022 A1), in view of Edwards (US 6,002,968).
Regarding claim 11, Chu teaches
positioning an energy delivery device within the uterine cavity at a first location; (Fig. 1A, Char. 100: ablation device)
providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies a first dose of an applied energy to a uterine tissue; (Figure 4, step 116A; Pages 11-12, Par. [0097]: The tissue within the uterine cavity, where the device is positioned, is ablated; the energy applied for ablation is interpreted as the applied energy)
removing the energy delivery device from the first location in the uterine cavity; (Par. [0093]: Ablation device (100) is removed from the uterus)
positioning an antenna of the energy delivery device (Fig. 1A, Char. 104: antenna) in the uterine cavity at a second location (Par. [0121]) and altering application of energy to the energy delivery device via a second dose, wherein the delivered energy dose is a total energy dose absorbed by the uterine tissue, (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; The amount of energy required to fully ablate the first location would be considered a first predetermined target energy dose; the ablations of the additional locations could be considered additional “doses” of energy.) wherein a power level is adjustable after an initial application of energy to the uterine tissue. (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on feedback obtained during the ablation)
Chu further teaches real-time feedback using sensing modalities. (Par. [0136]-[0137])
Chu, as applied to claim 11 above, is silent regarding monitoring or calculating a returned power and a loss during energy delivery; determining a total delivered energy dose using the applied energy, the returned power, and the loss during energy delivery; and comparing the total delivered energy dose to the predetermined target energy dose; and wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source.
Haley, in a similar field of endeavor, teaches a microwave antenna system (abstract) configured to monitor or calculate a loss during energy delivery; and determine a total delivered energy dose using the applied energy, a returned power, and the loss during energy delivery; (Page 2, Par. [0022]; the measured return power would also represent the loss during energy delivery) wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source. (Par. [0022])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Chu, as applied to claim 11 above, to incorporate the monitoring and determining of Haley. This provides the benefit of a more accurate energy calculation, as suggested in Haley (Page 2, Par. [0023]).
The combination of Chu/Haley, as applied to claim 11 above, is silent regarding comparing the total delivered energy dose to the predetermined target energy dose;
Edwards, in a similar field of endeavor, teaches a microwave system. (Fig. 1-5) The system includes a controller (Fig. 14, Char. 404) connected to a calculation device (Fig. 14, Char. 400) configured to calculate a power and impedance; (Col. 10, Lines 1-7) wherein the calculated power is compared to a predetermined power value (interpreted as target energy dose) and the delivery of the microwave energy can be reduced, modified, or interrupted when this predetermined dose is reached. (Col. 11, Lines 10-21: by reducing, modifying, or interrupting the delivery of energy once the power and impedance values reach the limit, the power level would be adjustable after an initial application of energy to the uterine tissue.)
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Chu/Haley, as applied to claim 11 above, to incorporate the teachings of Edwards, and include the steps of comparing of a delivered energy dose to a target energy dose; and altering the application of energy to an energy delivery device when the delivered energy dose reaches the target energy dose as taught by Edwards. This provides the benefit of sufficiently delivering energy to treat a substantial portion of the uterus (Col. 2, Lines 43-45)
Regarding claim 13, the combination of Chu/Haley/Edwards, as applied to claim 11 above, teaches the loss during energy delivery comprises one or more losses due to one or more conditions selected from the group consisting of: radiation, dielectric heating, conduction, convection, reflection, and steam or vapor generation. (Haley: Page 2, Par. [0022] – it is implicit that this feature be present in the Chu/Haley/Edwards combination based on the rejection to claim 11 above.)
Regarding claim 14, the combination of Chu/Haley/Edwards, as applied to claim 11 above, teaches the loss during energy delivery comprises returned power determined by a portion of the applied energy that is reflected by the uterine tissue and received by the energy delivery device. (Haley: Page 2, Par. [0022] – it is implicit that this feature be present in the Chu/Haley/Edwards combination based on the rejection to claim 11 above.)
Regarding claim 15, the combination of Chu/Haley/Edwards, as applied to claim 11 above, teaches selecting and/or calculating the predetermined target energy dose prior to providing the energy based on one or more patient data. (Chu: [0097]: The microwave generator dose is automatically adjusted based on specific anatomical data (interpreted as patient data))
Regarding claim 16, the combination of Chu/Haley/Edwards, as applied to claim 15 above, teaches the one or more patient data comprises data selected from the group consisting of, an anatomic feature, an anatomic measurement, a previous medical procedure, a medical condition, and a pain tolerance. (Chu: Page 2, Par. [0019]: A patient’s anatomical data includes anatomical dimensions)
Regarding claim 35, the combination of Chu/Haley/Edwards/Brannan360/Sampson, as applied to claim 11 above, teaches repositioning a hot spot of the energy delivery device to a different location in the uterine cavity and providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies an applied energy to the different location in the uterine cavity. (Chu: Par. [0121]-[0122])
Regarding claim 20, Chu teaches
positioning an energy delivery device adjacent to the tissue at a first location; (Fig. 1A, Char. 100: ablation device)
providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies a first dose of an applied energy to the tissue; (Figure 4, step 116A; Pages 11-12, Par. [0097]: The tissue within the uterine cavity, where the device is positioned, is ablated; the energy applied for ablation is interpreted as the applied energy)
adjusting a power level based on one or more inputs obtained after an initial application of energy to the tissue; (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on feedback obtained during the ablation)
withdrawing the energy delivery device from the first location; (Par. [0093]: Ablation device (100) is removed from the uterus)
stopping application of energy to the energy delivery device when the total delivered energy dose reaches a predetermined maximum target energy dose; (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; The amount of energy required to fully ablate the first location would be considered a first predetermined maximum target energy dose.) and
positioning an antenna of the energy delivery device (Fig. 1A, Char. 104: antenna) in the uterine cavity at a second location (Par. [0121]) and altering application of energy to the energy delivery device via a second dose when the total delivered energy dose reaches the predetermined maximum target total energy dose, wherein the delivered energy dose is a total energy dose absorbed by the uterine tissue, (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; The amount of energy required to fully ablate the first location would be considered a first predetermined target energy dose; the ablations of the additional locations could be considered additional “doses” of energy.) wherein a power level is adjustable after an initial application of energy to the uterine tissue. (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on feedback obtained during the ablation)
Chu further teaches real-time feedback using sensing modalities. (Par. [0136]-[0137])
Chu, as applied to claim 20 above, is silent regarding monitoring a returned power by determining a portion of the applied energy reflected by the tissue and received by the energy delivery device; determining a total delivered energy dose using the applied energy and returned power, wherein the returned power is measured throughout application of energy to the tissue; comparing the total delivered energy dose to the predetermined maximum target energy dose; and wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source.
Haley, in a similar endeavor, teaches a similar microwave antenna system (Abstract) configured to calculate a delivered energy by tracking forward power set by the user (i.e. applied energy) and the reflected power returning to the generator (Page 2, Par. [0022]; and Page 5, Par. [0066]-[0067]; note this is necessarily done relative to time as the measurements are taken in real time over the course of the procedure, see specifically in [0066] “…periodically measures and/or records one of forward and reflected power”). Based on these monitored parameters, the energy delivered to the tissue can be estimated (Page 2, Par. [0022]) and displayed for the user (Page 6, Par. [0082]) wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source. (Par. [0022])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Chu to incorporate the monitoring and determining of Haley. Doing so would allow the benefit of a more accurate energy calculation, as suggested in Haley. (Page 2, Par. [0023])
The combination of Chu/Haley, as applied to claim 20 above, is silent regarding wherein the returned power is measured throughout application of energy to the tissue; comparing the total delivered energy dose to the predetermined maximum target energy dose.
Edwards, in a similar field of endeavor, teaches a microwave system. (Fig. 1-5) The system includes a controller (Fig. 14, Char. 404) connected to a calculation device (Fig. 14, Char. 400) configured to calculate a power and impedance; (Col. 10, Lines 1-7) wherein the calculated power is compared to a predetermined power limit (interpreted as target energy dose) throughout application of energy to the tissue and the delivery of the microwave energy can be reduced, modified, or interrupted when this predetermined dose is reached. (Col. 11, Lines 10-21: by reducing, modifying, or interrupting the delivery of energy once the power and impedance values reach the limit, the power level would be adjustable after an initial application of energy to the uterine tissue.)
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Chu/Haley, as applied to claim 20 above, to incorporate the teachings of Edwards, and include the steps of comparing of a delivered energy dose to a target energy dose; and altering the application of energy to the energy delivery device when the delivered energy dose reaches the target energy dose as taught by Edwards. This provides the benefit of sufficiently delivering energy to treat a substantial portion of the uterus (Col. 2, Lines 43-45)
In this combination, the returned power would be measured throughout application of energy to the tissue in order for the delivery of energy to be interrupted, reduced or modified (Edwards: Col. 11, Lines 10-21) due to the returned power being used to calculate the delivered energy. (Haley: Par. [0022])
Regarding claim 21, the combination of Chu/Haley/Edwards, as applied to claim 20 above, teaches determining the delivered energy dose comprises using the applied energy, returned power, and a loss from the energy delivery device coupled to the energy delivery source. (Haley: Par. [0022]; the measured return power would also represent the loss during energy delivery)
Regarding claim 22, the combination of Chu/Haley/Edwards, as applied to claim 20 above, teaches selecting and/or calculating the maximum target energy dose prior to providing the energy based on one or more patient data. (Chu: [0097]: The microwave generator dose is automatically adjusted based on specific anatomical data (interpreted as patient data))
Regarding claim 23, the combination of Chu/Haley/Edwards, as applied to claim 22 above, teaches the one or more patient data comprises data selected from the group consisting of an anatomic feature, an anatomic measurement, a previous medical procedure, a medical condition, and a pain tolerance. (Chu: Par. [0019]: A patient’s anatomical data includes anatomical dimensions)
Regarding claim 36, the combination of Chu/Haley/Edwards, as applied to claim 20 above, teaches repositioning a hot spot of the energy delivery device to a different location in the tissue and providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies an applied energy to the different location in the tissue. (Chu: Par. [0121]-[0122])
Claims 17, 18, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2010/0121319 A1), in view of Haley (US 2010/0082022 A1), in view of Edwards (US 6,002,968), as applied to claims 11 and 20 above respectively, and further in view of Kimrey (US 2013/0240513).
Regarding claims 17 and 24, the combinations of Chu/Haley/Edwards, as applied to claims 11 and 20 above respectively, is silent regarding determining a minimum target energy dose, that is less than a maximum target energy dose; and comparing the total delivered energy dose to the minimum target energy dose and stopping energy delivery when the total delivered energy dose is greater than the minimum target energy dose and when a returned power is greater than a desired returned power.
Kimrey, in a similar field of endeavor, teaches a method for controlling a microwave heating system for medical instruments. (abstract) the system determines a minimum target energy dose (Fig. 17, Char. 1610; Page 16, Par. [0147]: discusses determining a minimum power) and compares the determined values to the target value (Fig. 17, Char. 1630; Page 16, Par. [0147]) Based on this comparison, the system stops energy delivery. (Fig. 16, Char. 1530; Par. [0139]-[0140] “turning off one or more generators”) The system further will stop the delivering of energy when the return power is greater than the desired return power ([0146]-[0147] refers to shutting down the generator when the return power exceeds the maximum, i.e. the desired return power).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combinations of Chu/Haley/Edwards, as applied to claims 11 and 20 above respectively, to incorporate the step of determining, comparing, and stopping of Kimrey. This configuration provides the benefit of ensuring product safety and compliance, as suggested in Kimrey. (Page 15, Par. [0140])
Regarding claims 18 and 25, the Chu/Haley/Edwards/Kimrey combinations, as applied to claims 17 and 24 above respectively, teach selecting and/or calculating the minimum target energy dose based on one or more patient data. (Chu: Pages 11-12, Par. [0097] refers to automatically adjusting the microwave generator dose based on specific anatomical data, interpreted as patient data)
Regarding claim 26, the combination of Chu/Haley/Edwards/Kimrey, as applied to claim 25 above, teaches the one or more patient data comprises data selected from the group consisting of an anatomic feature, an anatomic measurement, a previous medical procedure, a medical condition, and a pain tolerance. (Chu: Par. [0097]: Uterine cavity measurements)
Claims 19 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2010/0121319 A1), in view of Haley (US 2010/0082022 A1), in view of Edwards (US 6,002,968), as applied to claims 11 and 20 above respectively, and further in view of Brannan et al. (hereinafter “Brannan025”) (US 2010/0082025 A1).
Regarding claims 19 and 27, the combination of Chu/Haley/Edwards, as applied to claims 11 and 20 above respectively, teaches monitoring or calculating the loss during energy delivery comprises measuring a magnitude of a returned power; measuring a mismatch between a tissue impedance and an impedance of the energy delivery device, and measuring a return loss. (Haley: Page 2, Par. [0022] – it is implicit that this feature be present in the Chu/Haley/Edwards/Brannan360/Sampson combinations based on the respective rejections to claims 11 and 20 above.)
The combination of Chu/Haley/Edwards, as applied to claims 11 and 20 above respectively, is silent regarding the monitoring or calculating of the loss during energy delivery comprises measuring a phase of the returned power to an applied power, measuring a characteristic of a standing wave on a transmission line, measuring a reflection coefficient, and measuring an S-parameter S.sub.11.
Brannan025 discloses a microwave energy delivery and measurement system. (Abstract) The system calculates return power during energy delivery (Page 2, Par. [0018]) and varies the output signal based on the measured returned power. (Page 2, Par. [0019]) The system is capable of measuring the phase of the reflected (returned) power (Page 7, Par. [0101]) as well as measuring a standing wave characteristic when delivering energy (Page 3, Par. [0031]) in order to dissipate the standing waves. In order to improve the output signal, the system of Brannan will also actively measure the reflection coefficient, return (i.e. reflected) loss, the ratio of the return power to the applied power, (Page 8, Par. [0102]) and/or the S.sub.11 parameter to better understand the system and control further energy delivery. (Page 9, Par. [0122])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combinations of Chu/Haley/Edwards, as applied to claims 11 and 20 above respectively, to incorporate the measurements and control of Brannan025 because this allows for various aspects of the generator to be controlled (Brannan025: Page 5, Par. [0069]), both in an active and passive manner (Page 9, Par. [0122]), thereby providing a more accurate energy delivery signal.
Claims 28, 29, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2010/0121319 A1), in view of Haley (US 2010/0082022 A1), in view of Edwards (US 6,002,968), in view of Rick (US 2008/0319434 A1).
Regarding claims 28 and 29, Chu teaches
positioning an energy delivery device within the uterine cavity; (Fig. 1A, Char. 100: ablation device)
increasing the efficiency of energy delivery is achieved by changing a dimension or a shape of one or more portions of the energy delivery device such that a greater percentage of energy from the energy delivery source is delivered to the uterine cavity; (Chu: Par. [0122]: Any of the antennas (104) may be repositioned by at least rotation, proximal/distal/sideways movement, or increasing or reducing in size; As best understood by examiner, looking to applicant’s specification, repositioning (Par. [0061]) and changing the size/shape of the energy delivery device (Par. [0067]) are considered separate methods usable either together or individually (Par. [0059]: examples of such methods include one or more of) to increase the efficiency of energy delivery by an antenna, such as delivering a greater percentage of energy by an antenna to tissue for the same output of a generator supplying energy to the antenna. (Par. [0055]: one of more energy delivery methods may be used for one or more of…; Par. [0058]) Therefore, as best understood by examiner, it appears the increase in energy delivery efficiency is merely a result of following at least one of the steps listed in Par. [0059]-[0069]. Accordingly, one of ordinary skill in the art would expect the repositioning and changing of the antenna size taught by Chu to result in a change in the energy efficiency including the increase such that a greater percentage of energy from the energy delivery source is delivered to the uterine cavity claimed by applicant.)
providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies a first dose of an applied energy to a uterine tissue; (Figure 4, step 116A; Pages 11-12, Par. [0097]: The tissue within the uterine cavity, where the device is positioned, is ablated; the energy applied for ablation is interpreted as the applied energy)
withdrawing the energy delivery device from the uterine cavity; (Par. [0093]: Ablation device (100) is removed from the uterus)
altering application of energy to the energy delivery device when the delivered energy dose reaches the target energy dose, (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; Given broadest reasonable interpretation, pausing/ceasing energy delivery would be considered altering application of energy delivery) wherein a power level is adjustable after an initial application of energy to the uterine tissue; (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on a feedback obtained during the ablation)
positioning an antenna of the energy delivery device (Fig. 1A, Char. 104: antenna) in the uterine cavity (Fig. 4, step 112A; Pages 11-12, Par. [0097]: Ablation device (100) is inserted trans-cervically into the uterine cavity) and altering application of energy to the energy delivery device via a second dose to when a total delivered energy dose reaches the predetermined target total energy dose, wherein the delivered energy dose is a total energy dose absorbed by the uterine tissue, (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; The amount of energy required to fully ablate the first location would be considered a first predetermined target energy dose; the ablations of the additional locations could be considered additional “doses” of energy.) wherein a power level is adjustable after an initial application of energy to the uterine tissue. (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on feedback obtained during the ablation)
positioning an antenna of the energy delivery device (Fig. 1A, Char. 104: antenna) in the uterine cavity (Fig. 4, step 112A; Pages 11-12, Par. [0097]: Ablation device (100) is inserted trans-cervically into the uterine cavity) and altering application of energy to the energy delivery device via a second dose to when the delivered energy dose reaches a predetermined target energy dose, (Par. [0121]: Antenna (104) can be used to ablate a first location in the uterine cavity, repositioned to additional locations within the uterine cavity, and used to ablate said additional locations; The amount of energy required to fully ablate the first location would be considered a first predetermined target energy dose; the ablations of the additional locations could be considered additional “doses” of energy.) wherein a power level is adjustable after an initial application of energy to the uterine tissue. (Par. [0112]: the microwave generator is capable of automatically adjusting the magnitude of power delivery based on a feedback obtained during the ablation)
Chu further teaches real-time feedback using sensing modalities. (Par. [0136]-[0137])
Chu, as applied to claim 28 above, is silent regarding increasing the efficiency of energy delivery by the energy delivery device by reducing a measured return power to a value under a limit of 50% of any other measured value; monitoring or calculating a returned power and a loss during energy delivery; determining a total delivered energy dose using the applied energy, the returned power, and the loss during energy delivery; comparing the total delivered energy dose to the target energy dose; and wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source.
Haley, in a similar field of endeavor, teaches Haley, in a similar field of endeavor, teaches a microwave antenna system (abstract) configured to monitor or calculate a loss during energy delivery; and determine a total delivered energy dose using the applied energy, a returned power, and the loss during energy delivery, (Par. [0022]; the measured return power would also represent the loss during energy delivery) and wherein the delivered energy dose is different from an energy delivered to the device from the energy delivery source. (Par. [0022])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Chu, as applied to claim 28 above, to incorporate the monitoring and determining of Haley. This provides the benefit of a more accurate energy calculation, as suggested in Haley (Page 2, Par. [0023]).
The combination of Chu/Haley, as applied to claim 28 above, is silent regarding increasing the efficiency of energy delivery by the energy delivery device by reducing a measured return power to a value under a limit of 50% of any other measured value; and comparing the total delivered energy dose to the target energy dose.
Edwards, in a similar field of endeavor, teaches a microwave system. (Fig. 1-5) The system includes a controller (Fig. 14, Char. 404) connected to a calculation device (Fig. 14, Char. 400) configured to calculate a power and impedance; (Col. 10, Lines 1-7) wherein the calculated power is compared to a predetermined power value (interpreted as target energy dose) and the delivery of the microwave energy can be reduced, modified, or interrupted when this predetermined dose is reached. (Col. 11, Lines 10-21: by reducing, modifying, or interrupting the delivery of energy once the power and impedance values reach the limit, the power level would be adjustable after an initial application of energy to the uterine tissue.)
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Chu/Haley, as applied to claim 28 above, to incorporate the teachings of Edwards, and include the steps of comparing of a delivered energy dose to a target energy dose; and altering the application of energy to an energy delivery device when the delivered energy dose reaches the target energy dose as taught by Edwards. This provides the benefit of sufficiently delivering energy to treat a substantial portion of the uterus (Col. 2, Lines 43-45)
The combination of Chu/Haley/Edwards, as applied to claim 28 above, is silent regarding increasing the efficiency of energy delivery by the energy delivery device by reducing a measured return power to a value under a limit of 50% of any other measured value.
Rick, in a similar field of endeavor, teaches an electrosurgical generator (Fig. 1, Char. 20: electrosurgical generator) comprising a controller (Fig. 1, Char. 22: controller) configured to be responsive to measured electrical characteristics of one or more energy pulses (Par. [0054]), wherein the measured characteristics include reflective power (Par. [0054]) and are measured continuously; (Par. [0062]) and wherein the controller is configured to decrease a power level in order to maintain a reflective power under a threshold value of 1-20% of reflective energy. (Par. [0062])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Chu/Haley/Edwards, as applied to claim 28 above, to incorporate the teachings of Rick, and configure the controller of Chu to continuously monitor the returned power throughout application of energy to a target tissue, and to control the power level of the delivered energy such that the reflective power is maintained under a threshold value of 1-20% of reflective energy. Doing so would allow for improved energy efficiency over the course of the procedure, as suggested in Rick. (Par. [0062])
Regarding claim 37, the combination of Chu/Haley/Edwards/Rick, as applied to claim 28 above, teaches repositioning a hot spot of the energy delivery device to a different location in the uterine cavity and providing energy to the energy delivery device from the energy delivery source, such that the energy delivery device applies an applied energy to the different location in the uterine cavity. (Chu: Par. [0121]-[0122])
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2010/0121319 A1), in view of Haley (US 2010/0082022 A1), in view of Edwards (US 6,002,968), in view of Rick (US 2008/0319434 A1), as applied to claim 29 above, and further in view of Thompson (US 5,820,591).
Regarding claim 30, the combination of Chu/Haley/Edwards/Rick, as applied to claim 29 above, teaches adjusting a size of the energy delivery structure. (Chu: Par. [0122]: Any of antennas (104) may be reduced or increased in size.)
The combination of Chu/Haley/Edwards/Rick, as applied to claim 29 above, is silent regarding changing a dimension and/or a shape of one or more portions of the energy delivery device is performed by one or more of: pulling or pushing one or more energy delivery device regions, and translating and/or rotating one or more energy delivery device regions.
Thompson, in a similar field of endeavor, teaches a retracting or advancing a spline of a loop structure to decrease or increase the diameter of said loop structure. (Fig. 19A-C and Col. 11, Lines 58-61)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Chu/Haley/Edwards/Rick, as applied to claim 29 above, to incorporate the teachings of Thompson, and change a dimension of antenna (104) of Chu by pulling or pushing (retracting or advancing) a spline of antenna (104). Doing so would be a simple substitution of one method for controlling a loop size for another, and would allow for a simple way for the user to control the size of antenna (104).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794
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