DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 55 is objected to because of the following informalities: “wherein capturing he baseline heat flux measurement” in line 1 should be amended to --wherein capturing the baseline heat flux measurement--. 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 54-58, 60-64, and 68-73 are rejected under 35 U.S.C. 103 as being unpatentable over Rensen et al., US 20110245713, herein referred to as “Rensen”, in view of Hautvast et al., US 20170165503, herein referred to as “Hautvast”, further in view of Allison, US 20100081971, herein referred to as “Allison”.
Regarding claim 54, Rensen discloses a system for distributed heat flux sensing of body tissue (Figures 2-3: medical device 1), the system comprising: a distributed sensor (Figures 2 and 4: thermopile 7) configured to provide a plurality of temperature measurements corresponding to a plurality of points in a measurement range ([0043] and [0045]); a thermal energy source (Figures 2 and 4: heat source 9) configured to apply thermal energy to the body tissue along the measurement range ([0044]); and one or more processors ([0033]: “Alternatively, the wireless data transmission may occur directly between the probe and the outside analyzing device.” Wherein the analyzing device is a processor) configured to: initiate an ablation procedure on target tissue at the target site ([0060]: “The medical device according to embodiments of the present invention may be used in biopsy procedures, during treatment of inflammation or for monitoring the effect of ablation during an ablation procedure.”); and capture a post-ablation heat flux measurement at the target site ([0057]-[0058] wherein q is heat flux and [0060]); and determine whether the target tissue was successfully ablated ([0003]: “A third example is to distinguish ablated tissue from non-ablated tissue during ablation procedures. Distinction may be useful to monitor the process of ablation and to verify whether the targeted tissue has been completely ablated.”). Rensen does not explicitly disclose a system comprising a distributed sensor including a fiber optic sensor, the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range; or a system comprising one of more processors configured to: capture a baseline heat flux measurement at a target site; capture a post-ablation heat flux measurement at the target site; and determine whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement.
However, Hautvast teaches a system (Figure 1) comprising a distributed sensor (Figure 4) including a fiber optic sensor (Figure 4: optical shape sensing fibers 17), the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range ([0057]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the distributed sensor includes a fiber optic sensor, the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range as taught by Hautvast in order to determine the position of each portion or section of a catheter (Hautvast [0057]).
Further, Allison teaches a system (Figure 1) comprising one of more processors (Figure 1: controller 114) configured to: capture a baseline heat flux measurement at a target site (Figure 8: 802 and 804 and Figure 13 and [0170]); initiate an ablation procedure on target tissue at the target site (Claim 43); capture a post-ablation heat flux measurement at the target site (Figure 13); and determine whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement ([0065]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the processor is configured to capture a baseline heat flux measurement at a target site; capture a post-ablation heat flux measurement at the target site; and determine whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 55, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Rensen further discloses a system wherein capturing the baseline heat flux measurement comprises: receiving the plurality of temperature measurements from the distributed sensor, the plurality of temperature measurements corresponding to the plurality of points; and determining an amount of thermal energy applied by the thermal energy source ([0057]-[0058] wherein q is heat flux).
Regarding claim 56, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Hautvast further discloses a system wherein the one or more processors are further configured to: determine a location of each of the plurality of points in a known three-dimensional reference frame based on shape data from the fiber optic sensor ([0057]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the distributed sensor includes a fiber optic sensor, the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range as taught by Hautvast in order to determine the position of each portion or section of a catheter so that the temperature at different portions or sections along the length of the respective catheter can be determined (Hautvast [0057]).
Regarding claim 57, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Hautvast further discloses a system wherein the distributed sensor is integrated with an ablation probe housing the thermal energy source (Figures 2 and 4 and [0063]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the distributed sensor is integrated with an ablation probe housing the thermal energy source as taught by Hautvast in order to determine the position of each portion or section of a catheter so that the temperature at different portions or sections along the length of the respective catheter can be determined (Hautvast [0057]).
Regarding claim 58, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Rensen further discloses a system wherein the distributed sensor is disposed external to an ablation probe housing the thermal energy source ([0060]; and Figure 2: flexible substrate is external to medical device 1).
Regarding claim 60, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Rensen further discloses a system further comprising a flexible catheter, wherein the ablation probe is mounted to or inserted through the flexible catheter and wherein the distributed sensor is mounted to or inserted through the flexible catheter ([0009]).
Regarding claim 61, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Allison further discloses a system wherein determining whether the target tissue was successfully ablated comprises determining whether the post-ablation heat flux measurement is greater than the baseline heat flux measurement (Figure 13 and [0065]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that determining whether the target tissue was successfully ablated comprises determining whether the post-ablation heat flux measurement is greater than the baseline heat flux measurement as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 62, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Allison further discloses a system wherein the one or more processors are further configured to: terminate the ablation procedure upon determining the target tissue was successfully ablated (Figure 13: 1310).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the one or more processors are further configured to: terminate the ablation procedure upon determining the target tissue was successfully ablated as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 63, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Allison further discloses a system wherein the one or more processors are further configured to: continue the ablation procedure upon determining the target tissue was not successfully ablated (Figure 13: 1314); capture a second post-ablation heat flux measurement at the target site (Figure 13: 1306); and determine whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the second post-ablation heat flux measurement (Figure 13: 1308).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the one or more processors are further configured to: continue the ablation procedure upon determining the target tissue was not successfully ablated; capture a second post-ablation heat flux measurement at the target site; and determine whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the second post-ablation heat flux measurement as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 64, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Rensen further discloses a system wherein the distributed sensor is configured to measure temperature at the plurality of points in a batch mode or a scanning mode (Figure 2: thermopile 7 and [0010] and [0048]: “Respective ends of the series connection of thermocouples 101 forming the thermopile 7 are connected to terminals 13.”).
Regarding claim 68, Rensen in view of Hautvast and Allison discloses the system of claim 54, and Rensen further discloses a system wherein the one or more processors ([0033]: "Alternatively, the wireless data transmission may occur directly between the probe and the outside analyzing device." Wherein the analyzing device is a processor) identify a type of tissue at each of the plurality of points based on the baseline heat flux measurement or post-ablation heat flux measurement ([0057]); and classify the type of tissue as at least one of cancerous, non-cancerous, ablated, non- ablated, or healthy ([0003] and [0009]).
Regarding claim 69, Rensen discloses a method (Figures 2-3: medical device 1), comprising: capturing a baseline heat flux measurement at a target site ([0057]-[0058] wherein q is heat flux and [0060]) using a distributed sensor (Figures 2 and 4: thermopile 7) configured to provide a plurality of temperature measurements corresponding to a plurality of points in a measurement range ([0043] and [0045]); initiating an ablation procedure on target tissue at the target site using a thermal energy source configured to apply thermal energy to body tissue along the measurement range ([0060]: “The medical device according to embodiments of the present invention may be used in biopsy procedures, during treatment of inflammation or for monitoring the effect of ablation during an ablation procedure.”); capturing a post-ablation heat flux measurement at the target site ([0057]-[0058] wherein q is heat flux and [0060]); and determining whether the target tissue was successfully ablated ([0003]: “A third example is to distinguish ablated tissue from non-ablated tissue during ablation procedures. Distinction may be useful to monitor the process of ablation and to verify whether the targeted tissue has been completely ablated.”). Rensen does not explicitly disclose a method comprising a distributed sensor including a fiber optic sensor, the fiber optic sensor including an optical fiber extending through the measurement range and configured to measure a shape of the fiber optic sensor along the measurement range; or a method comprising: capturing a baseline heat flux measurement at a target site; capturing a post-ablation heat flux measurement at the target site; and determining whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement.
However, Hautvast teaches a method (Figure 1) comprising a distributed sensor (Figure 4) including a fiber optic sensor (Figure 4: optical shape sensing fibers 17), the fiber optic sensor including an optical fiber extending through the measurement range and configured to measure a shape of the fiber optic sensor along the measurement range ([0057]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Rensen so that the distributed sensor includes a fiber optic sensor, the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range as taught by Hautvast in order to determine the position of each portion or section of a catheter (Hautvast [0057]).
Further, Allison teaches a method (Figure 1) comprising: capturing a baseline heat flux measurement at a target site (Figure 8: 802 and 804 and Figure 13 and [0170]); initiate an ablation procedure on target tissue at the target site (Claim 43); capturing a post-ablation heat flux measurement at the target site (Figure 13); and determining whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement ([0065]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Rensen so that it includes capturing a baseline heat flux measurement at a target site; capturing a post-ablation heat flux measurement at the target site; and determining whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the post-ablation heat flux measurement as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 70, Rensen in view of Hautvast and Allison discloses the method of claim 69, and Rensen further discloses a method wherein capturing the baseline heat flux measurement comprises: receiving the plurality of temperature measurements from the distributed sensor, the plurality of temperature measurements corresponding to the plurality of points; and determining an amount of thermal energy applied by the thermal energy source ([0057]-[0058] wherein q is heat flux).
Regarding claim 71, Rensen in view of Hautvast and Allison discloses the method of claim 69, and Hautvast further discloses a method further comprising: determining a location of each of the plurality of points in a known three-dimensional reference frame based on shape data from the fiber optic sensor ([0057]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Rensen so that it includes determining a location of each of the plurality of points in a known three-dimensional reference frame based on shape data from the fiber optic sensor as taught by Hautvast in order to determine the position of each portion or section of a catheter so that the temperature at different portions or sections along the length of the respective catheter can be determined (Hautvast [0057]).
Regarding claim 72, Rensen in view of Hautvast and Allison discloses the method of claim 69, and Allison further discloses a method further comprising: terminating the ablation procedure upon determining the target tissue was successfully ablated (Figure 13: 1310).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Rensen so that it includes terminating the ablation procedure upon determining the target tissue was successfully ablated as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Regarding claim 73, Rensen in view of Hautvast and Allison discloses the method of claim 69, and Allison further discloses a method further comprising: continuing the ablation procedure upon determining the target tissue was not successfully ablated (Figure 13: 1314); capturing a second post-ablation heat flux measurement at the target site (Figure 13: 1306); and determining whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the second post-ablation heat flux measurement (Figure 13: 1308).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Rensen so it includes continuing the ablation procedure upon determining the target tissue was not successfully ablated; capturing a second post-ablation heat flux measurement at the target site; and determining whether the target tissue was successfully ablated by comparing the baseline heat flux measurement to the second post-ablation heat flux measurement as taught by Allison so that the system can use real-time feedback data to optimize treatment (Allison [0170]).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Hautvast and Allison, further in view of Igov, US 20150080933, herein referred to as “Igov”.
Regarding claim 59, Rensen in view of Hautvast and Allison discloses the system of claim 54, but does not explicitly disclose a system wherein the distributed sensor is configured to be withdrawn from the target site prior to initiating the ablation procedure and reinserted to the target site prior to capturing the post-ablation heat flux measurement.
However, Igov teaches a system wherein the distributed sensor is configured to be withdrawn from the target site prior to initiating the ablation procedure and reinserted to the target site ([0135]). In combination with Rensen and Allison, the sensor will be reinserted to the target site prior to capturing the post-ablation heat flux measurement.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the distributed sensor is configured to be withdrawn from the target site prior to initiating the ablation procedure and reinserted to the target site as taught by Igov to verify a location of the device post placement (Igov [0135]).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Hautvast and Allison, further in view of Schaer, US 6251107, herein referred to as “Schaer”.
Regarding claim 65, Rensen in view of Hautvast and Allison discloses the system of claim 54, but does not explicitly disclose a system wherein the thermal energy source includes a conductive cladding around the distributed sensor that is configured to heat upon application of electric current.
However, Schaer teaches a system (Figure 1) wherein the thermal energy source includes a conductive cladding around the distributed sensor that is configured to heat upon application of electric current (Col. 5, lines 36-57).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the thermal energy source includes a conductive cladding around the distributed sensor that is configured to heat upon application of electric current as taught by Schaer to insulate the sensor from RF noise present as a result of the energy sent to the electrodes (Schaer Col. 5, lines 42-47).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Hautvast and Allison, further in view of Ryan et al., US 20120143176, herein referred to as “Ryan”.
Regarding claim 66, Rensen in view of Hautvast and Allison discloses the system of claim 54, Rensen further discloses a system wherein the one or more processors ([0033]: "Alternatively, the wireless data transmission may occur directly between the probe and the outside analyzing device." Wherein the analyzing device is a processor) are further configured to calculate heat flux ([0057]- [0058] wherein q is heat flux). Further, Hautvast discloses a system (Figure 1) wherein the distributed sensor comprising a fiber optic sensor including an optical fiber (Figure 4: optical shape sensing fibers 17) wherein the one or more processors are further configured to: determine a location of each of the plurality of points based on a shape of the optical fiber by determining at least one of a position and an orientation of the fiber optic sensor in a known three-dimensional reference frame ([0057]). Rensen in view of Hautvast and Allison does not explicitly disclose a system wherein the one or more processors are further configured to: generate a heat flux map based on the determined shape of the optical fiber.
However, Ryan teaches a system (Figure 5) wherein the one or more processors (Figure 5: control module 140) are further configured to generate a heat flux map (Figure 4 and [0011] and [0037]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the distributed sensor includes a fiber optic sensor, the fiber optic sensor including an optical fiber that extends through the measurement range and is configured to measure a shape of the fiber optic sensor along the measurement range as taught by Hautvast in order to determine the position of each portion or section of a catheter so that the temperature at different portions or sections along the length of the respective catheter can be determined (Hautvast [0057]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the one or more processors are configured to generate a heat flux map as taught by Ryan to determine the relationship between power density and depth in tissue (Ryan Figure 4).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Hautvast, Allison, and Ryan, further in view of Yuan et al., US 20090326381, herein referred to as "Yuan".
Regarding claim 67, Rensen in view of Hautvast, Allison, and Ryan discloses the system of claim 54, with Rensen disclosing a system wherein one or more processors ([0033]: "Alternatively, the wireless data transmission may occur directly between the probe and the outside analyzing device." Wherein the analyzing device is a processor) are further configured to calculate heat flux ([0057]-[0058] wherein q is heat flux and [0012]: "In a second example, the probe may be mounted next to an ultrasound transducer array on a medical instrument such as a catheter or a needle or a scope to enable local ultrasound imaging and measurement of temperature data."). Further, Hautvast discloses a system (Figure 1) wherein the distributed sensor comprising a fiber optic sensor including an optical fiber (Figure 4: optical shape sensing fibers 17) with a known three-dimensional reference frame ([0057]). Ryan teaches a system (Figure 5) wherein the one or more processors (Figure 5: control module 140) are further configured to generate a heat flux map (Figure 4 and [0011] and [0037]). Rensen in view of Hautvast, Allison, and Ryan does not explicitly disclose a system wherein the one or more processors are configured to: register an anatomical model or image of the body tissue to the known three-dimensional reference frame; overlay the heat flux map on the anatomical model or image of the body tissue; and display the anatomical model or the image of the body tissue with the overlay of the heat flux map.
However, Yuan discloses a system (Figure 1) wherein the one or more processors (Figure 1: data processing 104) are configured to register an anatomical model or image of the body tissue to the three- dimensional reference frame (Figures 13A-13B); overlay the heat flux map on the anatomical model or image of the body tissue (Figure 6: position fitting step 660 and Figure 7 and [0066]); and display the anatomical model or the image of the body tissue with the overlay of the heat flux map (Figure 6: define and identify step 680).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rensen so that the processor is capable of overlaying the heat flux map on the anatomical mode of the body tissue as taught by Yuan to assist in medical diagnosis (Yuan [0066]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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