DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 03/16/2026 has been entered. Claims 1, 3, 7-8, 15-16 and 18 have been amended. Claims 2 and 17 have been cancelled. New Claims 21 and 22 have been added. Claims 1, 3-16 and 18-22 remain pending.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 1-20 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 101 for Claims 1, 3-16, and 18-22 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Pages 16-18 of Remarks, regarding rejections under 35 USC 102, Applicant argues that reference Razban merely shows “sensor-less estimation versus actual force measurement” in its Fig. 11, and does not disclose the newly added limitations for Claims 1 and 15-16. Examiner respectfully disagrees. As discussed in the previous 35 USC 103 rejection for Claim 2, the limitation of displaying a blood vessel cross-sectional image is disclosed by reference Fox, which as discussed below also discloses the newly added limitation of the image including blood-vessel lumen, blood-vessel wall and a lesion portion; Fox also discloses the limitation of superimposing and displaying a direction of pressing the wire against an inner surface of blood vessel. The limitation of superimposing and displaying a strength of pressing the wire against an inner surface of blood vessel is disclosed by Razban. In Fig. 11 of Razban (cited by the previous rejection and also included in the Remarks), the force of a guidewire applied to different contact points of simulated blood vessel is superimposed and displayed in an image of simulated blood vessel, e.g. FC1 = 0.79 N in Fig. 11(a).
Claim Objections
Claims 1 and 15-16 are objected to because of the following informalities:
Claim 1 Line 11, Claim 15 Line 11 and Claim 16 Line 10, recite “cross-section image”, which should be changed to “cross-sectional image”.
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 (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, 5-6 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al (US 20170035514 A1; hereafter Fox), in view of Razban et al (Proc. 2018 IEEE/RSJ Int. Conf. Intell. Robots Syst. Page 2100-2106; hereafter Razban).
With regard to Claim 1, Fox discloses a non-transitory computer-readable medium storing a computer program (Fox, Para 0033; “… a non-transitory machine-readable storage medium 312 storing one or more sets of instructions (e.g. software 314) embodying any one or more of the methodologies or operations described herein.”) for causing a computer to execute processing comprising:
acquiring lesion information indicating a state of a lesion portion included in a blood vessel of a patient (Fox, Para 0044; “… an operator may enter data corresponding to a target anatomy for the interventional procedure … such as a lesion type or class …”. More details are in Para 0045 and 0046.) and bias information of a wire to be inserted into the blood vessel (Fox, Para 0063; “Derived additional deployment data may include a degree of malapposition of a medical device 602 deployed at a target anatomical site or a gap distance between the medical device 602 and the anatomical site.”; Para 0048; “In an embodiment, medical device 602 is a guidewire without working element 606.”);
specifying a recommended device that is a treatment device recommended to be used for treatment on the lesion portion, based on the lesion information and the bias information (“the current intervention data 904 record”; the disclosed “current intervention data” include lesion information (Para 0044-0046) and the bias information (Para 0063-0065)), and device information of the treatment device to be used for intravascular treatment (Fox, Para 0076; “… after determining a subset of the historical intervention data 902 records having the similarity to the current intervention data 904 record …, decision support data may be transmitted from server 204 to client 202 … the decision support data … may help an operator select the most appropriate size and characteristics of a subsequent implant device or accessory device …”);
displaying a blood vessel cross-sectional image representing a cross section of the blood vessel (Fox, Para 0050; “… an intravascular view of medical device 602 and/or working element 606 deployed in vessel 702. The intravascular view may be represented in an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”), the blood vessel cross-section image including a lumen of the blood vessel, a wall of the blood vessel, and a lesion portion within the blood vessel (Fox, Para 0050; “… an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”. Fig. 10 shows an example of IVUS images where lumen and wall of the blood vessel are displayed.); and
superimposing and displaying a direction of pressing the wire against an inner surface of the blood vessel at a position where the blood vessel cross-sectional image is obtained on the blood vessel cross-sectional image (Fox, Para 0065; “… an apposition arc 1006 may be defined as an arc length along the inner wall at which the implant is in direct apposition (or within a predetermined distance of) the inner wall.” The disclosed apposition arc is shown in an IVUS image in Fig. 10. The disclosed apposition arc indicates toward which direction an implant such as a wire presses the inner wall of blood vessel).
Fox does not clearly and explicitly disclose obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel.
Razban in the same field of endeavor discloses obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel (Razban, Abstract; “This study proposes a sensor-less sensing solution to estimate multiple contact point forces at the side of catheter/guidewire exerted on the vasculature … Image-based deflection measurement and contact points tracking data are given to a nonlinear finite element beam model to estimate the forces.” Fig. 11 shows an image of bended guidewire, simulating its insertion into a tortuous blood vessel, that is superimposed with estimated pressing force at multiple contact points). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, as suggested by Razban, in order to determine and display the strength of the force that a wire presses inner surface of blood vessel. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved safety for catheterization process by closely monitoring the pressing force of guidewire to blood vessel (Razban, Abstract; “Determination of catheter/guidewire-vessel interaction contact forces can improve the navigation process safety and efficiency which prevent injuries in both manual and robotic vascular interventions.”).
With regard to Claim 5, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
displaying a type and a severity of the lesion portion included in the lesion information (Fox, Para 0044; “The target anatomy may be measured or assessed using imaging system 104 to determine quantitative data, such as vessel diameter, or qualitative data, such as a lesion type or class. The measured/assessed data may be input by the operator using input device 110, and visually confirmed and/or edited using display device 106 …”).
With regard to Claim 6, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
displaying the specified recommended device (Fox, Para 0081; “… the decision support display may provide one or more procedural actions … a first option 1202 may be to perform post-dilatation using a 3.25 mm non-compliant balloon catheter at 22 atm.”).
With regard to Claim 14, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
specifying the recommended device (Fox, Para 0076; “… after determining a subset of the historical intervention data 902 records having the similarity to the current intervention data 904 record …, decision support data may be transmitted from server 204 to client 202 … the decision support data … may help an operator select the most appropriate size and characteristics of a subsequent implant device or accessory device …”), according to a type and a severity of the lesion portion included in the lesion information (“the current intervention data 904 record”; the disclosed “current intervention data” include lesion information (Para 0044-0046)) and a direction and a strength of pressing the wire against an inner surface of the blood vessel, included in the bias information (“the current intervention data 904 record”; the disclosed “current intervention data” include the bias information (Para 0063-0065)).
With regard to Claim 15, Fox discloses an information processing apparatus (Fox, Para 0031; “computer 108”) comprising:
a processor (Fox, Para 0031; “… such a processing system 300 can implement the software applications and the methods referred to herein …”) configured to:
acquire lesion information indicating a state of a lesion portion included in a blood vessel of a patient (Fox, Para 0044; “… an operator may enter data corresponding to a target anatomy for the interventional procedure … such as a lesion type or class …”. More details are in Para 0045 and 0046) and bias information of a wire to be inserted into the blood vessel (Fox, Para 0063; “Derived additional deployment data may include a degree of malapposition of a medical device 602 deployed at a target anatomical site or a gap distance between the medical device 602 and the anatomical site.”; Para 0048; “In an embodiment, medical device 602 is a guidewire without working element 606.”);
specify a recommended device that is a treatment device recommended to be used for treatment on the lesion portion, based on the lesion information and the bias information (“the current intervention data 904 record”; the disclosed “current intervention data” include lesion information (Para 0044-0046) and the bias information (Para 0063-0065)), and device information of the treatment device to be used for intravascular treatment (Fox, Para 0076; “… after determining a subset of the historical intervention data 902 records having the similarity to the current intervention data 904 record …, decision support data may be transmitted from server 204 to client 202 … the decision support data … may help an operator select the most appropriate size and characteristics of a subsequent implant device or accessory device …”);
display a blood vessel cross-sectional image representing a cross section of the blood vessel (Fox, Para 0050; “… an intravascular view of medical device 602 and/or working element 606 deployed in vessel 702. The intravascular view may be represented in an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”), the blood vessel cross-section image including a lumen of the blood vessel, a wall of the blood vessel, and a lesion portion within the blood vessel (Fox, Para 0050; “… an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”. Fig. 10 shows an example of IVUS images where lumen and wall of the blood vessel are displayed.); and
superimpose and display a direction of pressing the wire against an inner surface of the blood vessel at a position where the blood vessel cross-sectional image is obtained on the blood vessel cross-sectional image (Fox, Para 0065; “… an apposition arc 1006 may be defined as an arc length along the inner wall at which the implant is in direct apposition (or within a predetermined distance of) the inner wall.” The disclosed apposition arc is shown in an IVUS image in Fig. 10. The disclosed apposition arc indicates toward which direction an implant such as a wire presses the inner wall of blood vessel).
Fox does not clearly and explicitly disclose obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel.
Razban in the same field of endeavor discloses obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel (Razban, Abstract; “This study proposes a sensor-less sensing solution to estimate multiple contact point forces at the side of catheter/guidewire exerted on the vasculature … Image-based deflection measurement and contact points tracking data are given to a nonlinear finite element beam model to estimate the forces.” Fig. 11 shows an image of bended guidewire, simulating its insertion into a tortuous blood vessel, that is superimposed with estimated pressing force at multiple contact points). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, as suggested by Razban, in order to determine and display the strength of the force that a wire presses inner surface of blood vessel. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved safety for catheterization process by closely monitoring the pressing force of guidewire to blood vessel (Razban, Abstract; “Determination of catheter/guidewire-vessel interaction contact forces can improve the navigation process safety and efficiency which prevent injuries in both manual and robotic vascular interventions.”).
With regard to Claim 16, Fox discloses an information processing method (Fox, Para 0006; “a method and system for facilitating clinical decisions during a catheterization procedure is provided”) comprising:
acquiring lesion information indicating a state of a lesion portion included in a blood vessel of a patient (Fox, Para 0044; “… an operator may enter data corresponding to a target anatomy for the interventional procedure … such as a lesion type or class …”. More details are in Para 0045 and 0046.) and bias information of a wire to be inserted into the blood vessel (Fox, Para 0063; “Derived additional deployment data may include a degree of malapposition of a medical device 602 deployed at a target anatomical site or a gap distance between the medical device 602 and the anatomical site.”; Para 0048; “In an embodiment, medical device 602 is a guidewire without working element 606.”);
specifying a recommended device that is treatment device recommended to be used for treatment on the lesion portion, based on the lesion information and the bias information (“the current intervention data 904 record”; the disclosed “current intervention data” include lesion information (Para 0044-0046) and the bias information (Para 0063-0065)), and device information of the treatment device to be used for intravascular treatment (Fox, Para 0076; “… after determining a subset of the historical intervention data 902 records having the similarity to the current intervention data 904 record …, decision support data may be transmitted from server 204 to client 202 … the decision support data … may help an operator select the most appropriate size and characteristics of a subsequent implant device or accessory device …”);
displaying a blood vessel cross-sectional image representing a cross section of the blood vessel (Fox, Para 0050; “… an intravascular view of medical device 602 and/or working element 606 deployed in vessel 702. The intravascular view may be represented in an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”), the blood vessel cross-section image including a lumen of the blood vessel, a wall of the blood vessel, and a lesion portion within the blood vessel (Fox, Para 0050; “… an IVUS image displayed on display device 320 to view, e.g., apposition of a deployed implant relative to an inner wall of vessel 702, calcification of a vessel 702, etc.”. Fig. 10 shows an example of IVUS images where lumen and wall of the blood vessel are displayed.); and
superimposing and displaying a direction of pressing the wire against an inner surface of the blood vessel at a position where the blood vessel cross-sectional image is obtained on the blood vessel cross-sectional image (Fox, Para 0065; “… an apposition arc 1006 may be defined as an arc length along the inner wall at which the implant is in direct apposition (or within a predetermined distance of) the inner wall.” The disclosed apposition arc is shown in an IVUS image in Fig. 10. The disclosed apposition arc indicates toward which direction an implant such as a wire presses the inner wall of blood vessel).
Fox does not clearly and explicitly disclose obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel.
Razban in the same field of endeavor discloses obtaining and displaying a strength of pressing the wire against an inner surface of a blood vessel (Razban, Abstract; “This study proposes a sensor-less sensing solution to estimate multiple contact point forces at the side of catheter/guidewire exerted on the vasculature … Image-based deflection measurement and contact points tracking data are given to a nonlinear finite element beam model to estimate the forces.” Fig. 11 shows an image of bended guidewire, simulating its insertion into a tortuous blood vessel, that is superimposed with estimated pressing force at multiple contact points). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, as suggested by Razban, in order to determine and display the strength of the force that a wire presses inner surface of blood vessel. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved safety for catheterization process by closely monitoring the pressing force of guidewire to blood vessel (Razban, Abstract; “Determination of catheter/guidewire-vessel interaction contact forces can improve the navigation process safety and efficiency which prevent injuries in both manual and robotic vascular interventions.”).
Claims 3, 7-10, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fox and Razban, in view of Hayashi et al (Circ Cardiovasc Interv 11(10):e007003; hereafter Hayashi).
With regard to Claim 3, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
displaying a fluoroscopic image in which the blood vessel is fluoroscopically viewed from outside of the patient (Fox, Para 0050; “… a fluoroscope capable of generating an extravascular view of medical device 602 deployed in a vessel 702. The extravascular view may be represented in a fluoroscopic image 704 displayed on display device 320.”).
Fox and Razban as discussed above do not clearly and explicitly disclose superimposing and displaying a trajectory of a plurality of positions in the blood vessel where the blood vessel cross-sectional image is created and a position where the displayed blood vessel cross-sectional image is created, on the fluoroscopic image.
Hayashi in the same field of endeavor discloses superimposing and displaying a trajectory of a plurality of positions in the blood vessel where the blood vessel cross-sectional image is created and a position where the displayed blood vessel cross-sectional image is created, on the fluoroscopic image (Hayashi, Figure 1A is an angiogram, overlaid with positions where multiple cross-sectional OCT images (Figure 1 B-D) are captured). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Hayashi, in order to display position of cross-sectional images on vessel image captured outside of patient. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurate assessment of a lesion by simultaneously viewing the cross-sectional occlusion through the affected blood vessel and viewing the surrounding vascular tree and other potential lesions in it.
With regard to Claim 7, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1, but do not clearly and explicitly disclose superimposing and displaying a treatment range by the specified recommended device on the blood vessel cross-sectional image.
Hayashi in the same field of endeavor discloses superimposing and displaying a treatment range by the specified recommended device on the blood vessel cross-sectional image (Hayashi, Figure 1D’ is an OCT cross-sectional image, superimposed with a treatment range (highlighted with yellow shadow)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Hayashi, in order to superimpose and display a treatment range on a cross-sectional image. One of ordinary skill in the art would have been motivated to make the modification for the benefit of optimizing treatment by visualizing treatment range and then making proper adjustment.
With regard to Claim 8, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising receiving designation of a use device to be used for treatment on the lesion portion (Fox, Para 0090; “… an ordering element 1214 may be provided by the user interface to allow the operator to select the device for use …”).
Fox and Razban as discussed above do not clearly and explicitly disclose superimposing and displaying a treatable range of the lesion portion by the use device on the blood vessel cross-sectional image.
Hayashi in the same field of endeavor discloses superimposing and displaying a treatable range of the lesion portion by the use device on the blood vessel cross-sectional image (Hayashi, Figure 1D’ is an OCT cross-sectional image, superimposed with a treatment range (highlighted with yellow shadow)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Hayashi, in order to superimpose and display a treatment range on a cross-sectional image. One of ordinary skill in the art would have been motivated to make the modification for the benefit of optimizing treatment by visualizing treatment range and then making proper adjustment.
With regard to Claim 9, Fox, Razban and Hayashi disclose the non-transitory computer-readable medium according to claim 8. Fox further discloses comprising:
displaying a fluoroscopic image in which the blood vessel is fluoroscopically viewed from outside of the patient (Fox, Para 0050; “… a fluoroscope capable of generating an extravascular view of medical device 602 deployed in a vessel 702. The extravascular view may be represented in a fluoroscopic image 704 displayed on display device 320.”); and
superimposing and displaying a position of the use device in the blood vessel when the use device is used, on the fluoroscopic image (Fox, Para 0081; “… after deploying a stent implant in vessel 702 and capturing images of the deployed implant, as the operator is retrieving the stent delivery catheter from the anatomy, the image data and current intervention data 904 are sent to server 204. Then, as the operator is viewing the image data …”).
With regard to Claim 10, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1, but do not explicitly and clearly disclose comprising making a display indicating that a wire bias is inappropriate, in a case where the bias information is not suitable for the intravascular treatment.
Hayashi in the same field of endeavor discloses comprising making a display indicating that a wire bias is inappropriate, in a case where the bias information is not suitable for the intravascular treatment (Hayashi, Page 1, “Angiography showed ViperWire guidewire bias and coronary dilatation, distal to the calcified target lesion (Figure 1A’). OCT over the ViperWire was then performed, revealing … excessive ablation of the normal segment distal to the calcified lesion (Figures 1D’ and 2B through 2I).” Figure 1D is an OCT image acquired before treatment, showing inappropriate wire bias at the location of D. Figure 1D’ shows that the treatment with inappropriate wire bias led to excessive ablation at location D or D’.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Hayashi, in order to make a display indicating that a wire bias is inappropriate for treatment. One of ordinary skill in the art would have been motivated to make the modification for the benefit of preventing adverse complication induced by inappropriately guided treatment device (Hayashi, Page 1; “To prevent critical complications induced by any medical device, operators need to understand the mechanisms of its action … the extremely high stiffness of the ViperWire straightened the tortuous vessel with significant wire bias, which might contribute to the injurious ablation of noncalcified tissue and subsequent development of a pseudoaneurysm or contained perforation.”).
With regard to Claim 18, Fox and Razban disclose the method according to claim 16. Fox further discloses comprising displaying a fluoroscopic image in which the blood vessel is fluoroscopically viewed from outside of the patient (Fox, Para 0050; “… a fluoroscope capable of generating an extravascular view of medical device 602 deployed in a vessel 702. The extravascular view may be represented in a fluoroscopic image 704 displayed on display device 320.”).
Fox and Razban as discussed above do not clearly and explicitly disclose superimposing and displaying a trajectory of a plurality of positions in the blood vessel where the blood vessel cross-sectional image is created and a position where the displayed blood vessel cross-sectional image is created, on the fluoroscopic image.
Hayashi in the same field of endeavor discloses superimposing and displaying a trajectory of a plurality of positions in the blood vessel where the blood vessel cross-sectional image is created and a position where the displayed blood vessel cross-sectional image is created, on the fluoroscopic image (Hayashi, Figure 1A is an angiogram, overlaid with positions where multiple cross-sectional OCT images (Figure 1 B-D) are captured). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Hayashi, in order to display position of cross-sectional images on vessel image captured outside of patient. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurate assessment of a lesion by simultaneously viewing the cross-sectional occlusion through the affected blood vessel and viewing the surrounding vascular tree and other potential lesions in it.
With regard to Claim 20, Fox, Razban and Hayashi disclose the method according to claim 18. Fox further discloses comprising displaying a type and a severity of the lesion portion included in the lesion information (Fox, Para 0044; “The target anatomy may be measured or assessed using imaging system 104 to determine quantitative data, such as vessel diameter, or qualitative data, such as a lesion type or class. The measured/assessed data may be input by the operator using input device 110, and visually confirmed and/or edited using display device 106 …”).
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Razban and Hayashi, in view of Kuo et al (WO 2022069303 A2; hereafter Kuo).
With regard to Claim 4, Fox, Razban and Hayashi disclose the non-transitory computer-readable medium according to claim 3, but do not explicitly and clearly disclose comprising superimposing and displaying a position of the lesion portion on the fluoroscopic image.
Kuo in the same field of endeavor discloses superimposing and displaying a position of the lesion portion on the fluoroscopic image (Kuo, Para 00145; “Fig. 16 depicts angiography-based data 1650 overlaid on the angiography image 1600.”. In Fig. 16, blood vessel segment affected by a lesion is highlighted with a different color, which indicates the position of the lesion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, Razban and Hayashi, as suggested by Kuo, in order to superimpose and display a position of a lesion on the fluoroscopic image. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased accuracy in treatment recommendation by more effectively showing the location and length of a lesion to a vascular surgeon (Kuo, Para 0003; “… co-registration of data from invasive devices (e.g. intravascular ultrasound (IVUS)…) with images collected non-invasively (e.g. via x-ray angiography) is a powerful technique for improving the efficiency and accuracy of vascular catheterization procedures. Co-registration identifies the locations of intravascular data measurements along a blood vessel by mapping the data to an angiography image of the vessel. A physician may then know exactly where in the vessel a measurement was made, rather than estimate the location.”).
With regard to Claim 19, Fox, Razban and Hayashi disclose the method according to claim 18, but do not explicitly and clearly disclose comprising superimposing and displaying a position of the lesion portion on the fluoroscopic image.
Kuo in the same field of endeavor discloses superimposing and displaying a position of the lesion portion on the fluoroscopic image (Kuo, Para 00145; “Fig. 16 depicts angiography-based data 1650 overlaid on the angiography image 1600.”. In Fig. 16, blood vessel segment affected by a lesion is highlighted with a different color, which indicates the position of the lesion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, Razban and Hayashi, as suggested by Kuo, in order to superimpose and display a position of a lesion on the fluoroscopic image. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased accuracy in treatment recommendation by more effectively showing the location and length of a lesion to a vascular surgeon (Kuo, Para 0003; “… co-registration of data from invasive devices (e.g. intravascular ultrasound (IVUS)…) with images collected non-invasively (e.g. via x-ray angiography) is a powerful technique for improving the efficiency and accuracy of vascular catheterization procedures. Co-registration identifies the locations of intravascular data measurements along a blood vessel by mapping the data to an angiography image of the vessel. A physician may then know exactly where in the vessel a measurement was made, rather than estimate the location.”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fox, Razban and Hayashi, in view of Takahashi et al (WO 2018221509 A1; hereafter Takahashi).
With regard to Claim 11, Fox, Razban and Hayashi disclose the non-transitory computer-readable medium according to claim 10, but do not clearly and explicitly disclose displaying a proposal of processing for enabling the intravascular treatment, including a change in a route through which the wire passes in the blood vessel and a change in the wire.
Takahashi in the same field of endeavor discloses displaying a proposal of processing for enabling the intravascular treatment, including a change in a route through which the wire passes in the blood vessel and a change in the wire (Takahashi, Para 0198; “… the route score calculation unit 141 can calculate the route score SR with higher accuracy. Therefore, the surgeon considers the ease of delivery of the medical instrument when delivering the medical instrument from among the plurality of routes RT of the blood vessel BV that can deliver the medical instrument to the target site RG. Furthermore, an appropriate route RT can be easily selected.” This disclosure shows that a change for a better route can be accurately proposed to a surgeon by calculating and displaying the scores of the routes) (Takahashi, Para 0201; “the experimental data may record the length and diameter of the device, the bending rigidity and the elastic modulus for each part constituting the device. … a representative device may be selected in advance, and the deformation of the blood vessel BV may be predicted using experimental data of the representative device.” This disclosure shows that vessel deformation and therefore route can be predicted based on the wire to be applied, suggesting that a specific route may be achieved by changing to a specific wire, e.g. with specific elasticity). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, Razban and Hayashi, as suggested by Takahashi, in order to propose a change in a route of wire or a change in the wire. One of ordinary skill in the art would have been motivated to make the modification for the benefit of preventing adverse complication and thus minimizing damage to blood vessel by providing surgeons with more appropriate route of wire or wire of different type in treatment.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fox, in view of Takahashi and Razban.
With regard to Claim 12, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
acquiring the bias information (Fox, Para 0063; “Derived additional deployment data may include a degree of malapposition of a medical device 602 deployed at a target anatomical site or a gap distance between the medical device 602 and the anatomical site.”), by generating the bias information including a direction of pressing the wire against an inner surface of the blood vessel at each position of the blood vessel (Fox, Para 0065; “… an apposition arc 1006 may be defined as an arc length along the inner wall at which the implant is in direct apposition (or within a predetermined distance of) the inner wall.”), based on data representing a shape of the blood vessel created based on a fluoroscopic image (Fox, Para 0066; “image analysis techniques may include quantitative coronary angiography (QCA) techniques that permit quantification of vessel morphology.”), and data representing a shape of the wire in a state of being inserted into the blood vessel created based on a fluoroscopic image in a state where the wire is inserted into the blood vessel (Fox, Para 0067; “… thresholding may be used to distinguish an implant, e.g., a stent, from the vessel wall …”; Para 0068; “object recognition techniques may be employed to identify a moving object, e.g., an implanted clip during a cardiac cycle will move, and to make measurements of the object.” These disclosures suggest that, with the disclosed image processing techniques, implanted devices can be identified and distinguished from surrounding tissue).
Fox and Razban as discussed above do not clearly and explicitly disclose using three-dimensional data, and generating a strength of pressing the wire against an inner surface of blood vessel and using elasticity of the wire.
Razban further discloses generating a strength of pressing the wire against an inner surface of blood vessel (Razban, Abstract; “This study proposes a sensor-less sensing solution to estimate multiple contact point forces at the side of catheter/guidewire exerted on the vasculature … Image-based deflection measurement and contact points tracking data are given to a nonlinear finite element beam model to estimate the forces.”) and using elasticity of the wire (Razban, Page 2106, Para 1; “Three-point-bending tests are performed to provide the equivalent bending modulus of the complex structure of guidewire to be used in the numerical 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 Fox and Razban, as further suggested by Razban, in order to determine the strength of the force that a wire presses inner surface of blood vessel and use elasticity of the wire in such determination. One of ordinary skill in the art would have been motivated to make the modification of determining the strength for the benefit of improved safety for catheterization process by closely monitoring the pressing force of guidewire to blood vessel (Razban, Abstract; “Determination of catheter/guidewire-vessel interaction contact forces can improve the navigation process safety and efficiency which prevent injuries in both manual and robotic vascular interventions.”), and make the modification of considering the elasticity of the wire because elasticity of a wire is the most critical factor in determining the strength of the force.
Fox and Razban as discussed above do not clearly and explicitly disclose using three-dimensional data.
Takahashi in the same field of endeavor discloses using three-dimensional data (Takahashi, Para 0040; “The image data DT2 of the living body BD is three-dimensional image data.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Takahashi, in order to use 3D image data in generating wire bias information. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurately determining bias of a wire that can be toward any direction in the three-dimensional space.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fox and Razban, in view of Kusu et al (US 20200155079 A1; hereafter Kusu).
With regard to Claim 13, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1. Fox further discloses comprising:
acquiring a blood vessel cross-sectional image representing a cross section of the blood vessel (Fox, Para 0050; “… imaging equipment includes an IVUS system capable of generating an intravascular view of medical device 602 and/or working element 606 deployed in vessel 702.”); and
inputting the acquired blood vessel cross-sectional image to an analysis method that outputs lesion information in a case where the blood vessel cross-sectional image is input and acquiring the lesion information output by the analysis method (Fox, Para 0064; “… IVUS image 1002 represents only one example of the types of images that may be captured and analyzed. For example, an OCT image may be captured and analyzed to assess a degree of calcification of a vessel prior to crossing the lesion with a guidewire.”).
Fox and Razban do not clearly and explicitly disclose the analysis method being a learned model.
Kusu in the same field of endeavor discloses the analysis method being a learned model (Kusu, Para 0127; “Using the lesion hardness information, the lesion to be treated first is determined. From the image information, the hardness was measured on the screen …”. Para 0134-0143 list multiple machine-learning models for determining hardness of lesion, including GAN, FFNN and CNN). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Kusu, in order to use a learned model to assess lesion. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving accurate and fast detection and diagnosis of intravascular lesion using powerful artificial intelligence approach (Kusu, Para 0132; “Artificial intelligence (AI) is a computer system with intelligent functions, such as inference and determination, and includes those having a learning function that automatically constructs a knowledge base and corrects erroneous knowledge.”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fox and Razban, in view of Altmann et al (US 7517318 B2; hereafter Altmann).
With regard to Claim 21, Fox and Razban disclose the non-transitory computer-readable medium according to claim 1, including indicating the direction and the strength of pressing the wire against the inner surface of the blood vessel, but do not explicitly and clearly disclose using a fan-shaped figure spreading from a center position of the wire.
Altmann in the same field of endeavor discloses using a fan-shaped figure spreading from a center position of the wire (Altmann, Column 19, Lines 35-41; “A beam icon 83 is used in association with projected 2-D image 87 to mark the area scanned by the ultrasound beam. As such, icon 83 is oriented and displayed in the same plane (same orientation) as projected image 87 in real-time as catheter 28 is moved within the patient's body. Icon 83 may comprise a web-like or fan-like linear depiction, preferably in color, such as red”. Fig. 6 shows the fan-shaped icon 83 that spreads from the catheter tip 99. The disclosed fan-shaped icon 83 represents the applied ultrasonic beam (also a type of mechanical force) by the catheter to the heart’s internal structure, which is analogous to the claimed feature). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox and Razban, as suggested by Altmann, in order to use a fan-shaped icon to display the force of a catheter applied to a tissue surface. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurately characterizing spatial distribution of the applied force produced by a cylinder-shaped wire or ultrasonic transducer that generates fan-shaped beams, so as to precisely guide interventional procedure.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fox, Razban and Altmann, in view of Koblish et al (US 20200107877 A1; hereafter Koblish).
With regard to Claim 22, Fox, Razban and Altmann disclose the non-transitory computer-readable medium according to claim 21, but do not explicitly and clearly disclose representing the strength of pressing the wire against the inner surface of the blood vessel by a color.
Koblish in the same field of endeavor discloses representing the strength of pressing the wire against the inner surface of the blood vessel by a color (Koblish, Para 0119; “the bodily lumen of the subject comprises a blood vessel …”; Para 0668; “in the embodiment of FIG. 37A, the data and other information provided to the user (e.g., in a pop-up or other separate window 8300) by hovering over or otherwise selecting an ablation 8202 can include … contact information 8320 …”; Para 0671 discloses the details of using different colors in a virtual gauge to represent different levels of contact force). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fox, Razban and Altmann, as suggested by Koblish, in order to use color to indicate the strength of contact force. One of ordinary skill in the art would have been motivated to make the modification for the benefit of visualizing the applied force in a quantitative way so that a clinician can easily discern to reduce the risk of injury (Koblish, Para 0671; “… a virtual gauge that provides a qualitative assessment (either alone or in addition to a quantitative assessment) of contact state or level of contact in a manner that is easily discernable by a clinician. … a “contact alert” color or gauge graduation may be provided to alert the user about engaging the catheter or other medical instrument with too much force (e.g., contact function values greater than 1)”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights