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 .
Applicant' s arguments, filed 2/12/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-10, 14, and 23-32 are the current claims hereby under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-8, 23, 25, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over by Takahashi et al. (US 20180160910 A1), hereto referred as Takahashi, and further in view of Hall et al. (US 20140031631 A1), hereto referred as Hall, and further in view of Cantú et al. (US 20210267463 A1), hereto referred as Cantú.
Regarding claim 1, Takahashi teaches a system for detecting temperature of a tissue during perfusion of a fluid into the tissue, the system comprising (Takahashi, ¶[0267]: "the present technology may be used for blood vessel detection. In this case, for example, cold physiological saline or glucose may be administered and a temperature change event of a blood vessel may be detected from the temperature image", describing a system for detecting changes in temperature of tissue perfused with a fluid): an imager configured to generate a thermal image from the data captured by the thermal detector to provide image data from the thermal detector of a temperature for the tissue being imaged (Takahashi, ¶[0120]: “The temperature image generation unit 181 obtains the information regarding the sensing result from the thermo sensor 125A and generates a temperature image on the basis of the information. The temperature image is an image illustrating temperature (or temperature distribution) of the sensing area. The temperature image generation unit 181 supplies the generated temperature image to the warning target detection unit 182. The thermo sensor 125A performs the sensing for a predetermined period, and the temperature image generation unit 181 generates the temperature image as a moving image of the predetermined period. That is, the temperature image generated by the temperature image generation unit 181 illustrates the change in time of the temperature (or temperature distribution) during the predetermined period”, this defines a “temperature image” as an image (visual data) of the sensing area and states it is generated as a moving image that illustrates change in time, supporting both the “visual data” concept and later “updated image/second data” logic).
Takahashi does not explicitly teach that the system comprises: a pump. Rather, Takahashi suggests the administration of substances, such as physiological saline or glucose, into the body for temperature-related detection (Takahashi, ¶[0267]). However, Takahashi does not specify a mechanism for delivering these substances, such as a pump, leaving it open-ended about how the perfusion process is actively regulated. Hall teaches a pump system, such as a peristaltic pump, configured to infuse and extract hypothermic fluid into and out from the patient through a catheter (Hall, ¶[0011], see also ¶[0124]–[0126]). One skilled in the art would have found it obvious to incorporate Hall's pump system into Takahashi's temperature-based monitoring framework to ensure precise and active fluid delivery. Since Takahashi already considers the importance of thermal detection during substance administration, using Hall's specific pump configuration would have been a predictable and beneficial modification. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Takahashi in view of Hall to include a pump for fluid delivery. This would have the benefit of enabling controlled and directed perfusion of fluids during procedures where tissue temperature is monitored, improving precision and consistency in delivery.
Takahashi does not explicitly teach that the system comprises: a fluid dispensing system coupled with the pump, wherein the fluid dispensing system provides the fluid, and wherein the pump pumps the fluid from the fluid dispensing system to the tissue. Rather, Takahashi describes administering physiological saline or glucose for temperature-related detection (Takahashi, ¶[0267]). However, while Takahashi implies that fluids are introduced into the body, it does not specify a structured source from which the fluid is drawn or how it is delivered to the pump. Hall discloses a hypothermia system that comprises multiple elements including a fluid reservoir, catheter, access device, and a pump system (Hall, Abstract, ¶[0076]). These elements collectively define a fluid dispensing system. The reservoir stores the perfusate, the catheter provides a delivery pathway, and the pump conveys the fluid—together forming an integrated delivery mechanism to perfuse tissue (Hall, Fig. 1A). Under the broadest reasonable interpretation, a "fluid dispensing system" encompasses these coordinated elements that act together to deliver fluid from a source to tissue. As such, Hall's full hypothermia system—including the fluid source, tubing/catheter, and pump—is considered to fulfill this role. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Takahashi in view of Hall to include a fluid dispensing system comprising the hypothermia system elements: reservoir, tubing, catheter, and pump, optionally enhanced with known IV control tools. This would have the benefit of forming a coherent and structured fluid delivery pathway that works seamlessly with the temperature monitoring functionality, enabling reliable perfusion of tissue with therapeutic fluids.
Takahashi does not explicitly teach that the system comprises: a thermal detector that captures visual data relating to thermal change of the tissue during the perfusion of the tissue with the fluid, wherein the thermal detector does not contact the tissue. Rather, Takahashi teaches temperature sensing and generation of temperature images for surgical monitoring, but its temperature sensing relies on a thermo sensor 125A placed in the body and therefore does not teach a non-contact thermal detector that captures visual data (Takahashi, ¶[0117], “The thermo sensor 125A measures the change in time of the temperature (temperature distribution) in the sensing area”, showing in-tissue sensing rather than non-contact).
Cantú teaches a thermographic camera configured for stand-off, non-contact imaging of a patient and the capture of thermographic images as visual data (Cantú, ¶[0069], “the examination cell 102 includes a single stationary thermographic camera 140 positioned on the perimeter of the interior examination volume of the examination cell 102”, demonstrating a non-contact, camera-based thermal detector positioned off the patient; Cantú, ¶[0075], “the examination cell 102 includes a thermographic camera 140 … in order to record multiple thermographic images in quick succession”, showing capture of thermographic images as the visual data used for assessment; see also [0065]–[0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Takahashi in view of Cantú to provide a thermal detector that captures visual data relating to a thermal change of the tissue, wherein the thermal detector does not contact the tissue. The combination is feasible because both references address thermal monitoring of a subject and use image-based or image-derivable thermal information during perfusion; substituting or augmenting Takahashi’s in-body temperature sensing with Cantú’s camera-based thermographic detector is a predictable use of known, non-contact thermography in a context already concerned with temperature-driven assessment. The modification would have been obvious because non-contact thermography is a well-understood alternative to contact sensors for observing temperature patterns over a field of view, enabling external monitoring without penetrating tissue and aligning with systems that already generate temperature images. The benefit of the combination is improved safety and workflow (no sensor insertion), broader coverage of the surgical/target field, and continuous visual thermal mapping that integrates naturally with Takahashi’s temperature image generation and Hall’s fluid-control loop, thereby enhancing real-time perfusion-related thermal assessment and control.
Takahashi does not explicitly teach that the system comprises: a computing device coupled with the pump, wherein the computing device is configured to operate the pump to control the perfusion based on the thermal change of the tissue. Rather, Takahashi discloses a system that monitors temperature changes in tissue using a thermal sensor (Takahashi, ¶[0117]) and generates temperature images based on the detected thermal data (Takahashi, ¶[0120]). Additionally, Takahashi describes a control unit that manages output information (Takahashi, ¶[0123]), but this unit only provides notifications and does not directly control a pump based on thermal changes. Hall discloses a controller that can automatically control infusion and extraction of hypothermic fluid based on sensed temperature (Hall, ¶[0058]), and may also titrate medication delivery based on vital signs, including temperature (Hall, ¶[0088]). Moreover, the controller is described as regulating parameters such as infusion rate and temperature (Hall, ¶[0093]), and as part of a feedback loop that responds to input from a temperature sensor to regulate flow rate and fluid temperature (Hall, ¶[0122]). One skilled in the art would have found it obvious to combine the teachings of Hall with Takahashi because Hall provides a well-known, temperature-responsive fluid control mechanism that complements Takahashi's thermal monitoring framework. Takahashi already discloses the acquisition and analysis of thermal data from tissue, and Hall provides a conventional solution for using such data in a closed-loop control system to modulate fluid flow. The integration is straightforward and predictable: it involves coupling Takahashi's detection and analysis of temperature changes with Hall's responsive actuation of fluid delivery based on those same temperature signals. The systems are compatible in scope and function, and the combination merely applies Hall's known feedback control logic to Takahashi's thermal imaging context, yielding a system capable of both detection and automated intervention. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Takahashi in view of Hall to include a computing device configured to control a pump based on thermal change. This combination would have the benefit of enabling closed-loop, automated fluid delivery to tissue in response to temperature feedback, improving therapeutic precision and reducing manual oversight.
Regarding claim 2, the modified Takahashi teaches that the system further comprises a controller to provide increased contrast between imaged areas of the thermal image having different temperatures (Takahashi enhances contrast in three different ways: (1) ¶[0203]: "A biological temperature abnormality warning image may be displayed as the image illustrating the site where the temperature abnormality occurs ... emphasized by a color or a pattern attached thereto such as the biological temperature abnormality warning image 243", where ¶[0274]: "The warning control target detection unit 311 detects a warning and an event subjected to the device control ... the warning control target detection unit 311 notifies a control unit 312 of that fact", describing a method for enhancing contrast in thermal imaging by highlighting abnormal temperature regions via a controller; (2)¶[0253]: "At step S227, the output control unit 184 superimposes the diagnosis image generated at step S226 on the captured image of the living body (surgical site) generated at step S221 and displays the same on a monitor 191", describing a controller that processes and overlays diagnostic images onto thermal images to improve visibility of temperature variations in relation to the physical image; (3) ¶[0297]: "In a case of a system including a plurality of light sources, the temperature control may also be performed by controlling illumination to weaken brightness and illumination to enhance the brightness", describing a controller adjusting brightness levels to enhance contrast between temperature variations. This adjustment improves the distinction between warm and cool regions by creating a clearer visual separation, enhances visibility of temperature differences in hybrid imaging, and aids human perception of thermal abnormalities by adapting the brightness to surrounding conditions).
Regarding claim 3, the modified Takahashi teaches that the system further comprises an alarm to indicate if the thermal change exceeds a predefined amount (Takahashi, ¶[0200]: "the warning target detection unit 182 of the monitoring device 113 may detect that the surgical site... is in a state of predetermined temperature or higher... the notification information generation unit 183 may generate, as the warning image, an image notifying of occurrence of a site in a state of predetermined temperature or higher", describing a system that detects when temperature surpasses a predefined threshold and generates an alarm via visual warning images to alert users).
Regarding claim 6, the modified Takahashi does not explicitly teach that the system further comprises a display communicatively coupled to at least one of the imager or the computing device, wherein the display displays the thermal image to a user. Rather, the modified Takahashi generates a temperature image that is expressly defined as an image (and as a moving image illustrating change over time) but describes the monitor output as a captured image with superimposed diagnosis/notification imagery rather than the temperature image itself (Takahashi, ¶[0120]; ¶[0252]–¶[0253]).
Cantú teaches a thermal imaging system in which thermographic images are captured and displayed to a user, including recording multiple thermographic images “in quick succession” and displaying “the set of thermographic images … of the patient’s torso” (Cantú, ¶[0075]; ¶[0121]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Cantú to provide a display that shows the thermal image captured by the thermal detector, because both references concern thermal imaging and diagnostic visualization of living tissue. The combination is feasible since the modified Takahashi already generates temperature images and includes a monitor/output-control path; substituting or augmenting its displayed content with Cantú’s directly captured thermal images is a predictable use of known thermographic display techniques. The modification would have provided the benefit of real-time, non-contact visualization of tissue temperature changes, improving diagnostic accuracy and user interpretability of thermal data.
Regarding claim 7, the modified Takahashi teaches that the computing device provides a set of clinical interventions to the user based on the thermal change (Takahashi, ¶[0271]: "monitoring device 113 may perform... device control of a surgical tool on the basis of an event in a living body detected from a temperature image and the like. For example, it is possible to control temperature of gas to be supplied into the living body or brightness of illumination light emitted in the living body on the basis of the temperature image measured in the living body", describing a system that monitors temperature and applies procedural modifications in response to detected changes, forming the basis for real-time clinical interventions; ¶[0275]: "When the control unit 312 is notified by the warning control target detection unit 311 that the event subjected to the device control is detected, this controls the surgical tool and the like according to the event via a surgical tool control device 115 and an insufflation device 116", describing a computing device that implements clinical interventions based on detected temperature-related events by adjusting medical equipment and procedural settings in response to thermal data).
Regarding claim 8, the modified Takahashi teaches that the computing device configured to execute an imaging algorithm that compares the thermal change to a standard and provides feedback on the thermal change relative to the standard (Takahashi, Fig. 4 and ¶[0120]: "The temperature image generation unit 181 obtains the information regarding the sensing result from the thermo sensor 125A and generates a temperature image on the basis of the information ... The temperature image generated by the temperature image generation unit 181 illustrates the change in time of the temperature (or temperature distribution) during the predetermined period"; ¶[0121]: "The warning target detection unit 182 detects a predetermined event to be warned on the basis of the temperature image (that is, the change in time of the temperature (or temperature distribution) in a predetermined period). This event to be warned is set in advance. That is, a pattern of the change of the temperature (or temperature distribution) is set in advance ... The warning target detection unit 182 detects the pattern of the change of the temperature (or temperature distribution) set in advance in the temperature image, thereby detecting the event corresponding to the pattern", describing an imaging algorithm that compares thermal changes to predefined patterns (standards), and detects deviations and provides a feedback warning as shown in the figure and ¶[0205]).
Regarding claim 23, Takahashi teaches that a method for imaging tissue comprises (Takahashi, ¶[0267]: "The present technology may be used for blood vessel detection. In this case, for example, cold physiological saline or glucose may be administered and a temperature change event of a blood vessel may be detected from the temperature image", describing a system for detecting changes in temperature of tissue perfused with a substance): generating, with an imager, a thermal image based on the data (Takahashi, ¶[0120]: “The temperature image generation unit 181 obtains the information regarding the sensing result from the thermo sensor 125A and generates a temperature image on the basis of the information. The temperature image is an image illustrating temperature (or temperature distribution) of the sensing area. The temperature image generation unit 181 supplies the generated temperature image to the warning target detection unit 182. The thermo sensor 125A performs the sensing for a predetermined period, and the temperature image generation unit 181 generates the temperature image as a moving image of the predetermined period. That is, the temperature image generated by the temperature image generation unit 181 illustrates the change in time of the temperature (or temperature distribution) during the predetermined period”, this defines a “temperature image” as an image (visual data) of the sensing area and states it is generated as a moving image that illustrates change in time, supporting both the “visual data” concept and later “updated image/second data” logic); and analyzing, with a computing device, the data using an imaging algorithm, wherein the imaging algorithm compares the thermal change relative to a predefined range (Takahashi, ¶[0303]: "It is possible that the above-described series of processes is executed by hardware or executed by software... the computer includes a computer built in dedicated hardware, a general-purpose personal computer... capable of executing various functions by various programs installed and the like", describing a computing device executing a software process, thus corresponding to an imaging algorithm aspect; [0290]: "the warning control target detection unit 311 may detect temperature not lower than temperature generated in the living body... the temperature image may be used to detect an area at temperature that harms an organ"; demonstrating that the imaging process compares detected thermal values to a physiological baseline, showing a predefined range; [0291]: "the warning control target detection unit 311 determines whether there is a site where the temperature is higher than dangerous temperature"; indicating that temperature values are explicitly compared against predefined thresholds).
Takahashi does not explicitly teach that the method comprises: capturing, with a thermal detector, visual data relating to a thermal change of the tissue, wherein the thermal detector does not contact the tissue. Rather, Takahashi teaches temperature sensing and generation of temperature images for surgical monitoring, but its temperature sensing relies on a thermo sensor 125A placed in the body and therefore does not teach a non-contact thermal detector that captures visual data (Takahashi, ¶[0117], “The thermo sensor 125A measures the change in time of the temperature (temperature distribution) in the sensing area”, showing in-tissue sensing rather than non-contact).
Cantú teaches a thermographic camera configured for stand-off, non-contact imaging of a patient and the capture of thermographic images as visual data (Cantú, ¶[0069], “the examination cell 102 includes a single stationary thermographic camera 140 positioned on the perimeter of the interior examination volume of the examination cell 102”, demonstrating a non-contact, camera-based thermal detector positioned off the patient; Cantú, ¶[0075], “the examination cell 102 includes a thermographic camera 140 … in order to record multiple thermographic images in quick succession”, showing capture of thermographic images as the visual data used for assessment; see also [0065]–[0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Takahashi in view of Cantú to provide a thermal detector that captures visual data relating to a thermal change of the tissue, wherein the thermal detector does not contact the tissue. The combination is feasible because both references address thermal monitoring of a subject and use image-based or image-derivable thermal information during perfusion; substituting or augmenting Takahashi’s in-body temperature sensing with Cantú’s camera-based thermographic detector is a predictable use of known, non-contact thermography in a context already concerned with temperature-driven assessment. The modification would have been obvious because non-contact thermography is a well-understood alternative to contact sensors for observing temperature patterns over a field of view, enabling external monitoring without penetrating tissue and aligning with systems that already generate temperature images. The benefit of the combination is improved safety and workflow (no sensor insertion), broader coverage of the surgical/target field, and continuous visual thermal mapping that integrates naturally with Takahashi’s temperature image generation and Hall’s fluid-control loop, thereby enhancing real-time perfusion-related thermal assessment and control.
Takahashi does not fully teach that a method for imaging tissue comprises pumping a substance through a fluid dispensing system to the tissue based on the analysis of the data, wherein the substance perfuses the tissue. Rather, Takahashi describes administering substances and detecting their effects on temperature (Takahashi, ¶[0267]) but does not disclose a specific fluid dispensing structure or feedback-controlled perfusion. Hall discloses a fluid dispensing system consisting of a reservoir, catheter, and pump controlled by a computing device (Hall, ¶[0011], ¶[0076], see also [0124]–[0126]) and describes feedback control of fluid delivery based on sensed temperature (Hall, ¶[0122]). One skilled in the art would have found it obvious to incorporate Hall's fluid dispensing and feedback control system into Takahashi's temperature-based imaging setup, as both references address medical scenarios involving temperature regulation through fluid delivery. Hall's temperature-responsive control system complements Takahashi's temperature-monitoring and analysis framework, allowing real-time adjustment of fluid delivery based on detected thermal changes. Such integration represents a predictable use of known elements to achieve a known benefit—automated regulation of tissue temperature during imaging or treatment. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Takahashi in view of Hall to include a temperature-controlled fluid dispensing system that responds dynamically to measured thermal changes in tissue. This combination would provide automated delivery of fluid in response to tissue temperature analysis, improving precision of temperature modulation and enhancing the therapeutic or diagnostic efficacy of the system.
Regarding claim 25, the modified Takahashi teaches that the system further comprises: providing a set of clinical interventions based on the thermal change (Takahashi, ¶[0271]: "monitoring device 113 may perform... device control of a surgical tool on the basis of an event in a living body detected from a temperature image and the like. For example, it is possible to control temperature of gas to be supplied into the living body or brightness of illumination light emitted in the living body on the basis of the temperature image measured in the living body", describing a system that monitors temperature and applies procedural modifications in response to detected changes, forming the basis for real-time clinical interventions; ¶[0275]: "When the control unit 312 is notified by the warning control target detection unit 311 that the event subjected to the device control is detected, this controls the surgical tool and the like according to the event via a surgical tool control device 115 and an insufflation device 116", describing a computing device that implements clinical interventions based on detected temperature-related events by adjusting medical equipment and procedural settings in response to thermal data).
Regarding claim 31, the modified Takahashi does not fully teach that the controller increases contrast between imaged areas by delivering increased or decreased contrast materials to the tissue. Rather, the modified Takahashi discloses a system for imaging biological tissue by detecting thermal changes induced by administering a substance such as cold saline or glucose (Takahashi, ¶[0267]). These substances act as thermal contrast agents, altering local temperatures and thereby creating thermal differentials that are visualized in temperature images (Takahashi, ¶[0120]). While the modified Takahashi demonstrates the use of such agents to enhance image contrast, it does not explicitly teach a controller configured to dynamically modulate the delivery of contrast material. Hall fills this gap by teaching a controller that dynamically regulates fluid infusion based on sensed physiological parameters (Hall, ¶[0058], ¶[0093], ¶[0122]). Although Hall describes hypothermic fluids rather than contrast agents, the underlying control mechanism is broadly applicable to regulated fluid delivery in response to sensor input. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Hall to include a controller that automatically increases or decreases the infusion of contrast materials to tissue in response to thermal imaging feedback. A skilled artisan would recognize that Hall’s controller functionality, although applied to hypothermic therapy, is equally applicable to contrast agent delivery, as both scenarios involve regulated fluid administration based on sensor data. This combination would allow real-time adjustment of contrast delivery to optimize image clarity between different tissue regions, improving diagnostic capabilities and the accuracy of image-guided procedures.
Claims 4, 9-10, 14, 24, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over by Takahashi et al. (US 20180160910 A1), hereto referred as Takahashi, and further in view of Hall et al. (US 20140031631 A1), hereto referred as Hall, and further in view of Cantú et al. (US 20210267463 A1), hereto referred as Cantú, and further in view of Xu et al. (CN 112791262 A), hereto referred as Xu.
The combined Takahashi, Hall, and Cantú teaches claim 1 and 23 as described above.
Regarding claim 4, the modified Takahashi does not fully teach that the system further comprises an alarm to indicate if the thermal change is outside of a predefined range. the modified Takahashi describes a system that monitors temperature abnormalities in biological tissue using thermal imaging. The system detects when temperature exceeds a dangerous level (Takahashi, ¶[0291]) and continuously tracks temperature deviations (Takahashi, ¶[0292]). Furthermore, it explicitly supports monitoring both temperature increases and decreases (Takahashi, ¶[0268]), indicating a temperature range-based approach. However, while the modified Takahashi suggests full-range monitoring, it does not explicitly define a predefined lower temperature threshold for triggering an alarm. Xu, who investigates operational control of a surgical pump based on temperature, explicitly states that the system detects both upper and lower temperature limits and dynamically adjusts system responses. It describes an automated alarm and control system that regulates temperature when it exceeds a preset range (Xu, ¶[0006]). Additionally, Xu confirms a defined lower threshold, stating that if temperature falls below a preset minimum, an alarm triggers (Xu, ¶[0100]). A person skilled in the art would have found it obvious to incorporate Xu’s explicit lower temperature detection system into the modified Takahashi’s high-temperature monitoring system to create a comprehensive temperature range-based alarm. the modified Takahashi already suggests a range-based concept (Takahashi, ¶[0268]), and Xu explicitly teaches a control system that monitors both high and low-temperature deviations. Integrating Xu’s dual-threshold alert system with the modified Takahashi’s imaging and monitoring capabilities would be a logical extension. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to use the alarm to indicate if the thermal change is outside of a predefined range. This would have the benefit of ensuring full-spectrum temperature monitoring, allowing for detection of both overheating and overcooling conditions, thereby improving patient safety and procedural outcomes.
Regarding claim 9, the modified Takahashi does not explicitly teach that the computing device is configured to execute an imaging algorithm that detects the thermal change between adjacent areas of the tissues and provides feedback on the thermal change based on predefined ranges. Rather, the modified Takahashi discloses a temperature imaging system capable of detecting thermal differences between adjacent areas of tissue. For instance, the modified Takahashi teaches identifying localized hot regions relative to surrounding tissue in temperature images (Takahashi, Figs. 5-6; ¶[0142]) and observing how heating spreads across tissue zones (Takahashi, ¶[0259]). These teachings illustrate detection of inter-region thermal differences within a spatial context, connoting implicit analysis between adjacent tissue areas. However, while the modified Takahashi enables identification of thermal variations, it does not disclose a structured algorithm for comparing detected changes to predefined temperature ranges or for generating feedback based on such comparisons. Xu supplements this by disclosing a computing device that monitors temperatures from multiple locations and applies a structured algorithm to compare each measurement to preset upper and lower thresholds (Xu, ¶[0107]) as well as comparison between areas (Xu, ¶[0097]-[0106]). These comparisons are used to determine perfusion responses, demonstrating feedback behavior. Furthermore, Xu recognizes that different regions require different temperature limits due to varied physiological responses (Xu, ¶[0111]), reinforcing the value of regionalized threshold logic in such imaging algorithms. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to incorporate a structured threshold-based algorithm for comparing thermal changes between adjacent tissue regions. One skilled in the art would have found it obvious to integrate Xu’s structured threshold-based logic into the modified Takahashi’s imaging system to provide feedback on thermal variation between neighboring areas. the modified Takahashi already provides spatial thermal resolution, and Xu enhances this with explicit comparative logic and response mechanisms based on preset ranges. This combination would improve medical imaging by enabling automated, region-aware thermal feedback analysis—enhancing diagnostic accuracy, facilitating timely intervention, and reducing manual workload during imaging-guided treatment.
Regarding claim 10, the modified Takahashi does not explicitly teach that the computing device executes an imaging algorithm that segments the thermal image into zones and analyzes the thermal change of the zones relative to a predefined range. The modified Takahashi describes a system that predefines anatomical zones and applies segmentation-based thermal analysis. The system divides the liver into predefined functional zones (Takahashi, ¶[0244]) and tracks heat propagation within these regions (Takahashi, ¶[0259]). Additionally, the segmented temperature regions are visually displayed for interpretation (Takahashi, ¶[0261]). However, while the modified Takahashi discusses segmentation and analysis, it does not explicitly define a systematic zone-based evaluation against a predefined temperature range. Xu expands on this by explaining that different tissue sites exhibit unique thermal properties due to variations in surface shape and tissue composition (Xu, ¶[0112]). Additionally, Xu describes a system where temperature sensors are assigned predefined maximum and minimum values per region (Xu, ¶[0107]), enabling a direct comparison between segmented zones based on preset thresholds. One skilled in the art would have found it obvious to integrate Xu's structured temperature range evaluation into the modified Takahashi’s thermal segmentation system. The modified Takahashi already provides a segmentation-based imaging process, and Xu enhances this by adding explicit predefined thermal ranges for comparative analysis. This integration would improve the diagnostic accuracy of temperature-based tissue monitoring by ensuring that segmented zones are systematically analyzed against standardized thresholds. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to have the computing device execute an imaging algorithm that segments the thermal image into zones and analyzes the thermal change of the zones relative to a predefined range. This combination would benefit medical imaging by providing a method for identifying abnormal thermal deviations across distinct anatomical regions, leading to more precise diagnostic outcomes and targeted interventions.
Regarding claim 14, the modified Takahashi does not explicitly teach that the set of clinical interventions includes automatic operation of the pump to control the perfusion based on the thermal change of the tissue. Rather, the modified Takahashi describes a system that monitors thermal changes and provides feedback for clinical interventions. The system includes a monitoring device that can detect temperature variations and issue warnings based on thermal events (Takahashi, ¶[0271]). Additionally, it provides device control based on detected temperature events (Takahashi, ¶[0275]). However, the modified Takahashi does not explicitly disclose an automated process for adjusting the pump in response to thermal changes of the tissue. Xu describes a system that dynamically controls fluid delivery based on detected temperature variations. The system determines fluid perfusion increments based on temperature difference ranges (Xu, ¶[0128]) and uses a predefined calculation method to adjust the number of perfusion channels to match temperature-related requirements (Xu, ¶[0132]). Additionally, the system regulates fluid flow by opening or closing perfusion channels based on preset maximum and minimum temperature values (Xu, ¶[0107]). Furthermore, Xu details an automated process where perfusion channels are activated when real-time temperature readings indicate the need for increased fluid delivery (Xu, ¶[0109]). One skilled in the art would have found it obvious to incorporate Xu’s temperature-based fluid regulation method into the modified Takahashi’s thermal monitoring and intervention system. The modified Takahashi already describes a system for detecting thermal changes and issuing warnings, and Xu complements this by introducing a structured method for automating fluid delivery based on temperature thresholds. The combination would allow for a more responsive medical intervention system that not only detects abnormal thermal conditions but also takes corrective action through automated perfusion control. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Takahashi in view of Xu to have the set of clinical interventions include automatic operation of the pump to control the perfusion based on the thermal change of the tissue. This combination would benefit medical procedures by enabling real-time automated perfusion adjustments based on dynamic thermal monitoring, improving efficiency, optimizing treatment responses, and enhancing patient safety.
Regarding claim 24, the modified Takahashi does not explicitly teach that generating the thermal image further comprises: dividing the thermal image into a set of zones, wherein the thermal change is based on temperature differences between the zones. The modified Takahashi describes a system that predefines anatomical zones and applies segmentation-based thermal analysis. The system divides the liver into predefined functional zones (Takahashi, ¶[0244]) and tracks heat propagation within these regions (Takahashi, ¶[0259]). Additionally, the segmented temperature regions are visually displayed for interpretation (Takahashi, ¶[0261]). However, while the modified Takahashi discusses segmentation and analysis, it does not explicitly define a systematic zone-based evaluation against a predefined temperature range. Xu expands on this by explaining that different tissue sites exhibit unique thermal properties due to variations in surface shape and tissue composition (Xu, ¶[0112]). Additionally, Xu describes a system where temperature sensors are assigned predefined maximum and minimum values per region (Xu, ¶[0107]), enabling a direct comparison between segmented zones based on preset thresholds as well as comparison between areas/zones (Xu, ¶[0097]-[0106]). One skilled in the art would have found it obvious to integrate Xu's structured temperature range evaluation into the modified Takahashi’s thermal segmentation system. the modified Takahashi already provides a segmentation-based imaging process, and Xu enhances this by adding explicit comparison of different areas/zones. This integration would improve the diagnostic accuracy of temperature-based tissue monitoring by ensuring that segmented zones are systematically analyzed against standardized thresholds. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to have a method that divides the thermal image into a set of zones, wherein the thermal change is based on temperature differences between the zones. This combination would benefit medical imaging by providing a method for identifying abnormal thermal deviations across distinct anatomical regions, leading to more precise diagnostic outcomes and targeted interventions.
Regarding claim 26, the modified Takahashi does not explicitly teach that the set of clinical interventions includes automatic operation of the pump to control the perfusion based on the thermal change of the tissue. The modified Takahashi describes a system that monitors thermal changes and provides feedback for clinical interventions. The system includes a monitoring device that detects temperature variations and applies procedural modifications in response to detected changes (Takahashi, ¶[0271]). Additionally, it provides device control based on detected temperature events (Takahashi, ¶[0275]). However, the modified Takahashi does not explicitly disclose an automated process for adjusting pump operation in response to thermal changes. Xu describes a system that dynamically controls fluid delivery based on detected temperature variations. The system determines fluid perfusion increments based on temperature difference ranges (Xu, ¶[0128]) and uses a predefined calculation method to adjust the number of perfusion channels to match temperature-related requirements (Xu, ¶[0132]). Additionally, the system regulates fluid flow by opening or closing perfusion channels based on preset maximum and minimum temperature values (Xu, ¶[0107]). Furthermore, Xu details an automated process where perfusion channels are activated when real-time temperature readings indicate the need for increased fluid delivery (Xu, ¶[0109]). One skilled in the art would have found it obvious to incorporate Xu’s temperature-based fluid regulation method into the modified Takahashi’s thermal monitoring and intervention system. The modified Takahashi already describes a system for detecting thermal changes and adjusting medical device operations, and Xu complements this by introducing a structured method for automating fluid delivery based on temperature thresholds. The combination would allow for a more responsive medical intervention system that not only detects abnormal thermal conditions but also takes corrective action through automated perfusion control. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to have the set of clinical interventions include automatic operation of the pump to control the perfusion based on the thermal change of the tissue. This combination would benefit medical procedures by enabling real-time automated perfusion adjustments based on dynamic thermal monitoring, improving efficiency, optimizing treatment responses, and enhancing patient safety.
Regarding claim 27, the modified Takahashi teaches that the system further comprises: capturing second data relating to a second thermal change induced by the perfusion of the tissue by the fluid (Takahashi, Fig. 4: the figure illustrates a system loop (for thermal changes in perfused tissue, ¶[0267]) where, after the first image is captured and analyzed, a new image is generated by the image sensor, ensuring continuous monitoring and comparison of thermal changes, which describes capturing secondary thermal data), but does not fully teach analyzing the second data to compare the second thermal change to the predefined range. The modified Takahashi describes a system that detects and monitors temperature variations in perfused tissue through continuous data capture, including subsequent temperature changes, i.e. second data (Takahashi, Fig. 4 and ¶[0290]). However, Takahashi does not explicitly disclose a structured comparison of detected thermal changes against a predefined temperature range, just temperature values. Xu expands on the modified Takahashi’s system by introducing a method for explicitly defining and comparing thermal changes using preset temperature thresholds, thereby ensuring a structured range-based evaluation rather than an inferred physiological comparison (Xu, ¶[0107]). Additionally, Xu describes how different tissue zones exhibit unique thermal responses due to structural variations, which can be analyzed for comparative purposes (Xu, ¶[0111]). This structured approach enables a direct evaluation of thermal changes relative to a predefined threshold, ensuring controlled thermal monitoring. One skilled in the art would have found it obvious to incorporate Xu’s structured temperature range evaluation into the modified Takahashi’s thermal monitoring system. The modified Takahashi already establishes a comparative framework for temperature detection, and integrating Xu’s explicit range-based method would improve precision and provide a systematic means of determining temperature deviations. The inclusion of Xu’s multi-site thermal response analysis further enhances the ability to detect temperature differences across adjacent tissue zones, refining the accuracy of the system. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to analyze the second data to compare the second thermal change to the predefined range. This enhancement has the benefit of enabling a more reliable and regulated evaluation process, reducing uncertainty in assessing thermal changes during perfusion, and ensuring that thermal deviations are analyzed dynamically for improved intervention.
The modified Takahashi does not explicitly teach implementing feedback control of the pump based on the comparison of the second thermal change to the predefined range. The modified Takahashi describes a continuous monitoring system for temperature changes (Takahashi, Fig. 4 and ¶[0267]). However, it does not explicitly disclose a mechanism for adjusting fluid perfusion based on these detected changes. Xu complements the modified Takahashi by introducing a system that establishes preset temperature thresholds and dynamically adjusts fluid delivery based on these values (Xu, ¶[0107]-[0110]). Xu describes how maximum and minimum temperature limits are assigned to each temperature acquisition device, regulating the opening and closing of perfusion channels accordingly (Xu, ¶[0107]). Furthermore, Xu describes an automated pump control system that determines whether additional fluid perfusion is required and adjusts the syringe pump accordingly (Xu, ¶[0109]). One skilled in the art would have found it obvious to integrate Xu’s automated pump regulation into the modified Takahashi’s temperature monitoring framework. The modified Takahashi already describes monitoring and comparing thermal changes, while Xu provides an explicit method for dynamically adjusting perfusion in response to real-time temperature variations. This integration ensures a closed-loop system where temperature feedback actively controls fluid perfusion, enhancing precision and responsiveness. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Xu to implement feedback control of the pump based on the comparison of the second thermal change to the predefined range. This would have the benefit of enabling real-time fluid adjustments based on ongoing temperature changes, ensuring that tissue remains within safe thermal limits and optimizing treatment efficacy.
Regarding claim 28, the modified Takahashi do not expressly teach that the method further comprises displaying the thermal image on a display; and displaying an updated thermal image on the display in response to capturing the second data. Rather, the modified Takahashi generates temperature images as moving images that illustrate change in time over a predetermined period, reflecting iterative acquisition during perfusion; however, its display path is described as a captured image with superimposed diagnosis/notification imagery rather than the temperature image itself (Takahashi, ¶[0120]; ¶[0285]; ¶[0252]–¶[0253]).
Cantú complements this by describing thermographic imaging capable of near-real-time assessment—recording multiple thermographic images “in quick succession” and displaying “the set of thermographic images … of the patient’s torso,” which supports updating what the user sees as each new thermographic capture arrives (Cantú, ¶[0075]; ¶[0121]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Cantú to display the thermal image on a display and to display an updated thermal image in response to capturing the second data. The combination is feasible because the modified Takahashi already executes iterative temperature-image generation within a monitor/output pathway, while Cantú provides non-contact thermographic capture and explicit display of sequential images. The result is a predictable, near-real-time thermal assessment where each newly captured dataset refreshes the displayed thermal image, improving responsiveness and diagnostic precision.
Regarding claim 29, the modified Takahashi teaches that the system further comprises: generating an alert in response to determining that the second thermal change continues to violate the predefined range (Takahashi, ¶[0274]: "...the warning control target detection unit 311 detects a warning and an event subjected to the device control. In a case where the event subjected to the device control is detected, the warning control target detection unit 311 notifies a control unit 312 of that fact. Also, in a case where the event to be warned is detected, the warning control target detection unit 311 supplies that fact to a notification information generation unit 183", describing a system that identifies temperature abnormalities and triggers a warning process; ¶[0281]: "At step S247, the notification information generation unit 183 generates abnormality occurrence notification information for notifying that an abnormality occurs as notification information. At step S248, the output control unit 184 superimposes the abnormality occurrence notification image being the image of the abnormality occurrence notification information on the captured image obtained via the CCU 111 and allows a monitor 191 to display the same", confirming that an alert is displayed when an abnormality is detected and persists; Fig. 4: The figure illustrates a process where thermal images are continuously captured and analyzed, showing sequential detection of thermal changes, including a second thermal change, reinforcing that the system actively monitors for ongoing violations and triggers alerts accordingly).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over by Takahashi et al. (US 20180160910 A1), hereto referred as Takahashi, and further in view of Hall et al. (US 20140031631 A1), hereto referred as Hall, and further in view of Cantú et al. (US 20210267463 A1), hereto referred as Cantú, and further in view of Yamazaki et al. (US 20180206799), hereto referred as Yamazaki.
The combined Takahashi, Hall, and Cantú teaches claim 1 as described above.
Regarding claim 5, the modified Takahashi does not fully teach that the system further comprises a lighting source, wherein the thermal detector is configured to be suspended above the tissue by the lighting source. The modified Takahashi describes a thermal imaging system used for detecting temperature variations related to perfusion (Takahashi, ¶[0267]) that includes a light source (Takahashi, ¶[0297]). Since detecting temperature-based perfusion changes requires precise image capture, the positioning of the thermal detector is crucial for obtaining accurate thermal readings. However, the modified Takahashi does not describe how the thermal detector is structurally supported or whether it is integrated with the light source for enhanced imaging stability. Yamazaki, who investigates a surgical microscope imaging system, describes an infrared thermocamera attached to a surgical microscope, which functions as both an imaging and lighting apparatus (Yamazaki, Fig. 2 and ¶[0022]). Additionally, Yamazaki details how the infrared thermocamera is positioned through an illuminating mirror that serves as an illumination start point, ensuring that the thermal detector captures an optimal monitoring area aligned with the illuminated field (Yamazaki, ¶[0029]). This demonstrates a structured approach for suspending the thermal detector in relation to the lighting source, enabling precise thermal monitoring. One skilled in the art would have found it obvious to integrate Yamazaki’s thermal detector positioning method into the modified Takahashi’s temperature-based perfusion monitoring system. Since the modified Takahashi already relies on thermal imaging for detecting perfusion changes, incorporating Yamazaki’s structured attachment to a light source would have been a logical and technically sound approach to ensure precise alignment between illumination and thermal detection. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Yamazaki to have the thermal detector suspended above the tissue by the lighting source. This would have the benefit of providing a stable and aligned positioning of the thermal detector using a lighting source, ensuring accurate monitoring of temperature variations and improving the clarity of thermal imaging for perfusion assessment.
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over by Takahashi et al. (US 20180160910 A1), hereto referred as Takahashi, and further in view of Hall et al. (US 20140031631 A1), hereto referred as Hall, and further in view of Cantú et al. (US 20210267463 A1), hereto referred as Cantú, and further in view of Dollar et al. (US 20130190717 A1), hereto referred as Dollar.
The combined Takahashi, Hall, and Cantú teaches claim 1 and 23 as described above.
Regarding claim 30, the modified Takahashi does not explicitly teach that the tissue is heart tissue and wherein the data relating to the thermal change of the heart tissue is captured during a cardioplegia procedure. The modified Takahashi describes a system for monitoring temperature changes in perfused tissue (Takahashi, ¶[0117], ¶[0267]). However, the modified Takahashi does not explicitly disclose its application to heart tissue during cardioplegia procedures. Dollar, who investigates a cardioplegia apparatus and method, provides a clear disclosure of cardioplegia procedures where the temperature of the heart is actively regulated and controlled (Dollar, ¶[0012], ¶[0015]). One skilled in the art would have found it obvious to integrate the modified Takahashi’s temperature monitoring techniques into Dollar’s cardioplegia system to enable direct monitoring of heart tissue thermal changes because both references address temperature control in perfused tissue. the modified Takahashi already teaches detecting temperature changes in blood vessels, which closely parallels the function of Dollar’s system in regulating heart temperature during cardioplegia. Given that Dollar describes an existing infrastructure for controlling cardioplegia temperature through an extracorporeal circuit, it would have been a straightforward application of the modified Takahashi’s imaging methods to improve real-time monitoring of heart tissue thermal changes. The integration of the modified Takahashi’s imaging would enhance precision in detecting and responding to temperature fluctuations, ensuring tighter feedback control and safer regulation of myocardial protection. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Takahashi in view of Dollar to have the tissue be heart tissue and the data relating to the thermal change of the heart tissue be captured during a cardioplegia procedure. This would have the benefit of enabling real-time thermal imaging to improve cardioplegia temperature control, ensuring safe and effective myocardial protection.
Regarding claim 32, the modified Takahashi does not fully teach that the pump receives bodily fluids from the fluid dispensing system. The modified Takahashi describes delivering fluids such as cold saline or glucose to tissue to generate a temperature differential used for imaging purposes (Takahashi, ¶[0267]), thus indicating the presence of a fluid dispensing system involved in delivery. However, it does not describe the structure or mechanism for receiving bodily fluids. Furthermore, it does not describe a return path for bodily fluids nor indicate that any such bodily fluids are recirculated through the pump. Hall complements this by teaching a system in which a pump is integrated into the fluid pathway, responsible for both delivering and removing fluids from the patient (Hall, ¶[0011]; ¶[0076]). Figure 1A of Hall shows a return line from the patient to the reservoir, suggesting a recirculation pathway. Although Hall does not explicitly state that the returned fluid includes bodily fluids, the overall structure implies a pathway for such recapture. Dollar reinforces the feasibility of recirculating bodily fluids, describing an extracorporeal circuit used during heart surgery where venous blood is diverted, temperature-controlled, and returned to the patient (Dollar, ¶[0005]). Furthermore, Dollar explains a setup where a pump combines blood from the extracorporeal system with additional solutions, then controls delivery to the patient (Dollar, ¶[0012]), demonstrating control of both incoming and outgoing fluid streams that contain bodily fluids. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined the modified Takahashi, Hall, and Cantú in view of Hall and Dollar to incorporate a pump that receives bodily fluids from the fluid dispensing system. Hall provides a suitable integrated fluid pathway, while Dollar confirms the standard practice of recirculating bodily fluids in medical systems using pump-based delivery and recovery. This combination would provide a clear and efficient mechanism for capturing and recirculating bodily fluids, improving system efficiency and enabling closed-loop fluid control in temperature-regulated diagnostic or therapeutic imaging applications.
Response to Arguments
Claim Rejections - 35 U.S.C. §103
Applicant's arguments filed 2/12/2026, pages 6-11, regarding the previous 35 U.S.C. §103 rejections to claims 1-10, 14, and 23-32 have been fully considered but are not persuasive. Specifically:
Applicant’s argument: Applicant asserts independent claim 1 is nonobvious because one of ordinary skill in the art would not have been motivated to combine Takahashi with Cantú and because the proposed combination lacks a reasonable expectation of success. Applicant argues the thermographic camera of Cantú “could not be used to capture visual data relating to a thermal change of the tissue described in Takahashi” because Takahashi is directed to an endoscopic surgery support system (FIG. 1) in which the relevant tissue is not exposed and Takahashi’s monitoring sensor is inserted into the body cavity via a trocar (Takahashi, [0069] to [0070]). Applicant further argues Cantú’s camera is mounted in an examination room and is used to capture thermographic images of a patient’s skin (Cantú, [0109]) and therefore, at best, Cantú can capture skin temperature rather than the claimed tissue thermal change. Applicant concludes that, for these reasons, the proposed modification does not provide the claimed non-contact thermal detector capturing visual data relating to thermal change of the tissue during perfusion, and therefore the rejection should be withdrawn.
Examiner’s response: The argument is not persuasive. The rejection relies on Cantú for the teaching of a thermographic camera used for standoff, non-contact capture of thermographic images as visual data, where the camera is positioned off the subject and records thermographic images in quick succession (Cantú, [0069]; [0075]; see also [0065] to [0067]). Takahashi is relied upon for generating and using a temperature image that illustrates temperature (or temperature distribution) and change over time, including in the perfusion context of administering cold physiological saline or glucose and detecting a temperature change event from the temperature image (Takahashi, [0120]; [0267]).
Applicant’s position that Takahashi and Cantú are incompatible because Takahashi describes an endoscopic embodiment does not defeat the proposed combination. For the purpose of clarification and in direct response to Applicant’s compatibility argument, Takahashi expressly indicates the system configuration shown is an example and is not limiting: "configuration of the endoscopic surgery support system 100 illustrated in FIG. 1 is an example, and the configuration of the endoscopic surgery support system 100 is not limited to the example in FIG. 1" (Takahashi, ¶[0085]), and Takahashi further indicates that the "present technology may be applied to, for example, the medical support device, an endoscope device, a microscope device, a computer controlling the devices, or a medical support system including a plurality of devices and the like" (Takahashi, Abstract; ¶[0322]). Accordingly, Takahashi’s thermal monitoring and temperature image generation framework is not confined to a single physical arrangement requiring a particular sensor placement (the sensor does not need to be mounted on the trocar as the Applicant asserts). Further, Takahashi 's Abstract expressly characterizes the disclosure as relating to a medical support device, a method thereof, and a medical support system for detecting an event based on change in time of temperature of a surgical site or around the surgical site, and does not limit the present technology to endoscopic-only or internal-only imaging. In view of these express teachings, it would have been a predictable design choice to employ Cantú’s known non-contact thermographic camera as a thermal detector for capturing thermographic image data without contacting tissue, and to use that thermographic image data to generate and use temperature images within Takahashi’s framework. Takahashi’s express statements of applicability and non-limiting system configuration address Applicant’s attempt to confine the teachings to a single sensor placement in a particular embodiment (Takahashi, ¶[0085]; Abstract; ¶[0322]). Thus, Applicant’s reliance on Takahashi’s endoscopic embodiments and trocar description is not persuasive because those disclosures describe an example implementation and do not limit Takahashi’s “present technology” to an endoscopic-only arrangement such that Takahashi “could not” use a non-contact thermal detector because one embodiment uses a trocar, and does not address the full scope of Takahashi’s teachings relied upon by the rejection.
Applicant’s assertion that Cantú is limited to “skin temperature” is not persuasive because claim 1 does not require that the thermal detector be limited to a particular clinical setting, nor does it require that the thermal detector be limited to a specific anatomical tissue type beyond “tissue.” Cantú is relied upon for its teaching of non-contact thermographic imaging and capture of thermographic images as visual data. The fact that Cantú describes an examination cell environment does not teach away from, and does not preclude, applying the known non-contact thermographic camera technology in other medical contexts. For the same reasons, Applicant’s “no reasonable expectation of success” argument is not persuasive, because the modification does not require Cantú to reproduce Takahashi’s specific endoscopic instrumentation; it requires using a known non-contact thermographic detector to obtain thermographic image data that can be used within Takahashi’s temperature-image framework, which is a predictable substitution or enhancement of one known thermal detection modality for/with another. The modification remains a predictable use of known non-contact thermography in a system already concerned with temperature driven assessment, and the combination would have provided the benefits articulated in the rejection, including improved workflow by avoiding tissue contact and enabling non-contact thermal imaging over a field of view.
Accordingly, the rejection of claim 1 under 35 U.S.C. 103 over Takahashi in view of Hall and further in view of Cantú is maintained.
Applicant’s argument: Applicant asserts claim 23 is allowable for the same reasons as claim 1.Examiner’s response: The argument is not persuasive. The rejection of claim 23 is maintained for the reasons stated above regarding claim 1 (also now incorporated into the claim 23 rejection above). Applicant’s remarks do not identify any specific limitation of claim 23 that is not taught or suggested by the applied references as applied in the rejection.
Applicant’s argument: Applicant asserts the dependent claims are allowable, at least by virtue of their dependency from claim 1 or claim 23.Examiner’s response: The argument is not persuasive. Since claim 1 and 23 are maintained as unpatentable for the reasons above, and Applicant has not provided separate argument for the additional dependent limitations, the rejections of the dependent claims are maintained for the reasons set forth in the corresponding rejections.
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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791