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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2024 was filed after the mailing date of the application on 11/21/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), and recites the limitation “the isothermal line” in line 17. There is insufficient antecedent basis for this limitation in the claim and the Examiner cannot determine if the isothermal line is the same as the predetermined isothermal line or an additional isothermal line. Appropriate correction is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-2 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Geric (US 2023/0051869), herein after Geric, in view of Arai (US 2023/0380695), herein after Arai.
Regarding claim 1, Geric teaches the following limitations:
“A medical camera system (Figure 7) for capturing images and processing the captured images to determine specific structures or conditions within a subject (abstract, p.[0003-0004]), the medical camera system comprising a camera configured to acquire images (74/75, p.[0054], Fig. 10) and a controller comprising hardware (p.[0043], 57), the controller being operatively coupled to the camera and configured to receive the acquired images and process output images (p.[0043], Fig. 7) wherein the controller is further configured to: detect at least one risk structure within the acquired images (wherein the risk structure is target vessel 45, seen in Fig. 9, described in p.[0052])”,
“estimate a lateral thermal spread (p.[0058-0061], where a lateral thermal spread is the heat model with trace 93, Fig. 16) generated during activation of the at least one treatment device in real-time based on one or more of settings and operational status of the at least one treatment device (step 102 describes optimal placement and energy level determined on the status of the treated tissue, described further in Figure 19 and p.[0062-0063])”.
Geric does not explicitly teach “detect one or more of a presence of at least one treatment device and guiding laser beam within the acquired images (treatment device with cutter 76, described in p.[0057-0058, 0060,0064], further shown in Figure 19)” but Arai does in an analogous biomedical device with camera imaging. Arai teaches “detect one or more of a presence of at least one treatment device and guiding laser beam within the acquired images” in p.[0108] which states that the trained model (a type of controller) detects the presence of a jaw from the endoscope (a treatment device) from the endoscope image (an acquired image), teaching the claimed limitation as described. It would have been obvious to one of ordinary skill in the art to use the system of Arai in Geric. As stated in Arai, by identifying the jaw of the endoscope the system can then better identify the tissue, and produces predictable results of determining the type of tissue.
Geric teaches “evaluate one of a distance or position of a predefined isothermal line relative to the at least one detected risk structure and cause at least one predetermined response when the distance between the at least one detected risk structure and the isothermal line falls below a predetermined threshold” with iso-thermal lines as disclosed in the temperature overlap at the edges of each color-coded interval in Fig. 11 and 19, with isothermal lines as the temperature overlays 80, 81, 106, and described in p.[0057,0064]. Because the iso-thermal lines are present, they are predetermined. Note also that Geric does teach a predetermined response (warning in step 107, warning indicator 111) is triggered when a nominal temperature, i.e., a certain iso-thermal line, at the risk structure, i.e., when the distance is “zero” above a damage threshold, as described in p.[0058-0064] and Figures 19-20.
Geric teaches that the distance or position is predefined of the iso-thermal line relative to a risk structure as evaluated and subsequently to cause a response if said distance falls below a predetermined threshold to prevent damage to the risk structure. The response threshold is present, and therefore predetermined. The system of Geric is equipped to measure the temperature of the treated tissue (the risk structure), terminate the application of energy based on the temperature of the treated tissue (a predetermined response), and can measure isothermal lines (temperature overlays 80, 81, 106).
Regarding claim 2, the limitations of claim 1 are taught as described above. Geric teaches the limitation “wherein the camera is configured to capture images via multiple light modalities” with the imagers 74/75, with visible light imager 74 and thermal imager 75 as described in p.[0054], where it is known that thermal imagers/cameras can operate in the infrared spectrum, therefore constituting multiple light modalities (visible and infrared) between the visible light imager and thermal imager for capturing images and teaching the claimed limitation as described.
Regarding claim 4, the limitations of claim 1 are taught as described above. Geric teaches the limitation “wherein the camera comprises an endoscopic camera head or an endoscope” in Figure 10. Geric teaches that the camera is part of an endoscope 63 and is considered to be an endoscopic head as described in p.[0053, 0054] and therefore teaches the claimed limitation as described.
Regarding claim 5, the limitations of claim 1 are taught as described above. Geric teaches the limitation “further comprising an alert system, wherein the at least one predetermined response comprises the controller causing the alert system to output one or more of a visual and audio warning” with the use of an alert system in Fig.18, which depicts the use of a warning indicator 97 (generated via the controller calculating an integral corresponding to an area proportional to the excess heat energy absorbed by the target vessel) in the form of a text message (a visual warning) as further described in p.[0061], teaching the claimed limitation as described. Note that the predetermined response is the accumulation of excess heat energy.
Regarding claim 6, the limitations of claim 1 are taught as described above. Geric teaches in p.[0063] that the controller is able to atomically check accumulated heating over a nominal temperature exceeding a damage threshold (a predetermined response) in step 106, and if the accumulated heat is above the damage threshold, a warning is issued (107) and the current cutting operation is terminated (deactivation of the at least one treatment device), teaching the claimed limitation as described.
Regarding claim 7, the limitations of claim 1 are taught as described above. Geric teaches that the settings of the treatment device can be modified and adapted through the power source 55 provided to the instrument 53 in p.[0043, 0044, 0063] and Fig. 7. Geric teaches in p.[0043] that the energy applied can be modified by changing the magnitude (energy levels, energy applied), duration of the energy applied and the modulation pattern (wave forms) of the applied voltage. Geric further describes in this paragraph that the device may also have a switch that allows for selective activation of the treatment device. Geric teaches in p.[0063] that the calculated optimal energy may also be displayed to the user, demonstrating another instance of the operational status/setting of the treatment device is communicated to the user during use. Figure 7 demonstrates that the power is also controlled by the controller before going to the device, demonstrating that the settings/operational status of the device comprises at least the power (energy supply) of the device.
Regarding claim 8, the limitations of claim 1 are taught as described above. Geric does not expressly teach that the controller is configured to detect one or more tissue types and tissue structures within the subject in order to optimize the estimation of the thermal spread. However, Geric does implicitly teach this limitation in p.[0057, 0059-0060] and Figures 11-15. Geric's device teaches that the camera views and overlays of Figs. 11-13 show that the device is capable of determining a favorable location for cutting and discerning when the cutter is not located in such a location, suggesting that the camera system is capable of determining a desired tissue type from an undesired tissue type for cutting. Geric also teaches in p.[0057] that the device has an automated analysis of images used to identify optimal locations for cutting a side branch and inform the user of these locations, suggesting that the device can detect different tissue types to determine optimal locations. Further, Geric teaches that the device is capable of prompting the user with a graphical representation of an arrow or similar icon to move the cutter to the favorable location, further suggesting that the device can determine a desired tissue type from an undesired tissue type, demonstrating that the device can discern between tissue types and tissue structures. Additionally, Geric teaches in p.[0060] that the heat exposure of a target vessel can be accumulated using a heat model, suggesting that the system can also determine the estimation of a thermal spread (a heat model). 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 system of Geric to have detect a tissue type in order to optimize the estimation of thermal spread. As stated in Geric, the system is already configured to assume a "go" and "no go" state based on the location of the cutters, and further, is equipt to determine accumulated heat exposure "so that the user can monitor and avoid harmful exposure to the target vessel" (p.[0060) and produces predictable results of treating favorable locations while avoiding extraneous damage to neighboring tissues.
Regarding claim 9, the limitations of claim 1 are taught as described above. Geric teaches the use of several overlays (80, 82, 83, 85) in the view field (as shown in Fig. 12, the display) and teaches the limitation as described.
Regarding claim 10, the limitations of claim 8 are taught as described above. Geric does not explicitly teach the use of artificial intelligence for creating one or more of an enhanced visualization overlay to detect the tissue types and/or structures. However, Geric does teach that the identification of target vessels and branching points (a tissue structure) to create "go" and "no go" overlays are determined by pattern recognition analysis in an automated process (p.[0052, 0055]). It is the Examiner's position that while Geric does not call this process artificial intelligence by name, an automated process that operates via pattern recognition constitutes artificial intelligence under broadest reasonable interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use artificial intelligence in Geric. The use of artificial intelligence in an automated pattern recognition system for creating enhanced overlays for tissue types produces predictable results of overlays for detecting tissue types and structures.
Regarding claim 11, the limitations of claim 1 are taught as described above. Geric teaches the use of a graphical user interface (58 or 60) with one or more colors, shapes, and other visual elements to display patient information (such as physiological parameters of patients, p.[0050]) and imaging data (p.[0042-0050]), therefore teaching the claimed limitation as described.
Regarding claim 12, the limitations of claim 1 are taught as described above. Geric teaches the use of at least one treatment device (53) coupled to the controller/image processor (57) in p.[0042-0043] and Figure 7, teaching the claimed limitation as described.
Regarding claim 13, the limitations of claim 11 are taught as described above. Geric teaches that the treatment device can be a high-frequency bipolar cutting device in p.[0036] " A bipolar or integrated bipolar cord 31 connects to a source of high frequency voltage, and includes conductors for supplying the voltage to electrodes on V-cutter 27 for cutting and cauterizing the side branches and connective tissue", and therefore teaches the claimed limitation as described.
Regarding claim 14, the limitations of claim 11 are taught as described above. Geric teaches that the controller can regulate the energy output in order to reduce excess energy output (energy utilization minimization scheme) in p.[0058] which states "a recommended amount of heat energy (e.g., target energy) to be applied can be determined by the controller and displayed as an energy indicator 88... the applied amount of energy may be automatically controlled once the user activates a cutting command (e.g., depresses a foot pedal or other switch) to sever the side branch".
Regarding claim 15,
“A method for capturing images and processing the captured images to determine specific structures or conditions within a subject (abstract, p.[0003-0004]), the method comprising: acquiring images by a camera (74/75, p.[0054], Fig. 10); detecting at least one risk structure within the acquired images (wherein the risk structure is target vessel 45, seen in Fig. 9, described in p.[0052])”,
“estimating a lateral thermal spread (p.[0058-0061], where a lateral thermal spread is the heat model with trace 93, Fig. 16) generated during activation of the at least one treatment device in real-time based on one or more of settings and operational status of the at least one treatment device (step 102 describes optimal placement and energy level determined on the status of the treated tissue, described further in Figure 19 and p.[0062-0063])”.
Geric does not explicitly teach “detecting the presence of at least one treatment device and guiding laser beam within the acquired images (treatment device with cutter 76, described in p.[0057-0058, 0060,0064], further shown in Figure 19)” but Arai does in an analogous biomedical device with camera imaging. Arai teaches “detect one or more of a presence of at least one treatment device and guiding laser beam within the acquired images” in p.[0108] which states that the trained model (a type of controller) detects the presence of a jaw from the endoscope (a treatment device) from the endoscope image (an acquired image), teaching the claimed limitation as described. It would have been obvious to one of ordinary skill in the art to use the system of Arai in Geric. As stated in Arai, by identifying the jaw of the endoscope the system can then better identify the tissue, and produces predictable results of determining the type of tissue.
Geric teaches “evaluating one of a distance or position of a predefined isothermal line relative to the at least one detected risk structure and cause at least one predetermined response when the distance between the at least one detected risk structure and the isothermal line falls below a predetermined threshold” with iso-thermal lines as disclosed in the temperature overlap at the edges of each color-coded interval in Fig. 11 and 19, with isothermal lines as the temperature overlays 80, 81, 106, and described in p.[0057,0064]. Because the iso-thermal lines are present, they are predetermined.
Geric teaches also “causing at least one predetermined response when the distance between the at least one detected risk structure and the isothermal lines falls below a predetermined threshold”. Geric does teach a predetermined response (warning in step 107, warning indicator 111) is triggered when a nominal temperature, i.e., a certain iso-thermal line, at the risk structure, i.e., when the distance is “zero” above a damage threshold, as described in p.[0058-0064] and Figures 19-20. The response threshold is present, and therefore predetermined. The system of Geric is equipped to measure the temperature of the treated tissue (the risk structure), terminate the application of energy based on the temperature of the treated tissue (a predetermined response), and can measure isothermal lines (temperature overlays 80, 81, 106).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Geric in view of Arai in further view of Kubo (US 2019/0008423), herein after Kubo.
Regarding claim 3, the limitations of claim 2 are taught as described above. Geric teaches “wherein the first modality comprises illumination with standard white light” with the use of a visible light imager 74 and thermal imager 75 in p.[0054], where it is known that thermal cameras can operate in the infrared spectrum. However, Geric/Arai does not explicitly teach “a second modality comprises illumination with near-infrared light”, but Kubo does in an analogous tissue observation system. Kubo teaches in p.[0005] that the system can use a second or third wavelength of light from the light source apparatus, and that the light can be in the visible range and in the near-infrared range (p.[0027,0031,0033]).
Therefore, 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 device of Geric to use near-infrared light. As seen in p.[0054-0055] of Geric, the thermal imager operates in the infrared spectrum in order to attain surface temperatures of the treated tissue, and is disclosed to be a result effective variable in that changing the spectrum of light used results in a change in the resolution of the temperature reported and produces predictable results of improving resolution of the temperature recorded.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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