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
Applicant’s amendments filed 01/21/2026 have been entered. Currently claims 1 and 3-21 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto (JP3892696B2) in view of Tanaka (US6149598A) and Chen (US20150351722A1).
Regarding claim 1, Tarumoto teaches a medical device (fig. 1 is of a endoscope bending [0024]) comprising:
a flexible elongate member having a proximal portion and a distal portion (see annotated fig. 1 the endoscope comprise the ultrasonic scanning unit 3a, optical observation unit 3b, and bending portion 2a [0008]);
a first transducer having a first focal region disposed along the distal portion of the flexible elongate member and the first transducer configured to generate a first image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]);
a second transducer along the distal portion of the flexible elongate member and the second transducer configured to generate a second image (fig. 4 ultrasonic probe 11 [0008]); and
an articulation joint disposed along the distal portion of the flexible elongate member between the first transducer and the second transducer (fig. 5 universal joint 20 is between the ultrasonic unit 3a and optical observation unit 3b and allows the scanning unit 3a to be rotatable [0011]-[0012] ), the articulation joint configured to position the second transducer to facilitate generation of the image (fig. 6 the universal joint 20 allows the ultrasonic probe to reposition).
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However Tarumoto is silent regarding the second transducer being within at least a portion of the first focal region of the first transducer.
In the same endoscope field of endeavor, Tanaka teaches the second transducer being within at least a portion of the first focal region of the first transducer (fig. 3 the endoscopic image pickup portion 13 has an observation field W1 and includes the ultrasonic transducers 19 col. 5 lines 46-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of ultrasonic transducers within the focal region of an optical sensor as taught by Tanaka to the base endoscopic device of Tarumoto, as both inventions relate to ultrasonic endoscopes, and would yield the predictable result of an ultrasonic endoscope with an articulation joint that can move the ultrasonic transducers into the focal region of the optical sensor to one of ordinary skill. One of ordinary skill would be able to perform such an application, and the results of Tarumoto having an ultrasonic endoscope that can have its transducers be in the focal region of an optical sensor are reasonably predictable. This would improve targeting accuracy and reduce the likelihood of unintended tissue contact or improper instrument positioning. One of ordinary skill would understand this combination would allow the universal joint of Tarumoto to be capable of moving the ultrasonic transducers into the focal region of the optical sensor and thus read upon the claim limitation.
However, the combination of references are still silent regarding the generation of an image based on the first and second images.
In the same ultrasound imaging field of endeavor, Chen teaches the generation of an image based on the first and second images ([0031] the computer generates an image based on image data from the ultrasound, optical coherence, and acoustic radiation force).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging system of Tarumoto with the transducers and the combining of images of Chen, as this would combine the advantages of high spatial resolution of OCT and the broad imaging depth of ultrasound (see Chen [0024]).
Regarding claim 3, modified Tarumoto teaches the device of claim 1, wherein Tarumoto further teaches the first transducer comprising an optical sensor, the first image comprising an optical image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]), the second transducer comprising an ultrasonic transducer and the second image comprising an ultrasound image (fig. 4 ultrasonic probe 11 [0008]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka and Chen as applied to claim 1 above, and in further view of Abraham (US20130218019A1).
Regarding claim 4, modified Tarumoto teaches the device of claim 1, but fails to explicitly disclose wherein the first transducer configured to generate the first image with a characteristic of a wall of a body lumen, and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen.
However in the same intraluminal field of endeavor, Abraham teaches the first transducer configured to generate the first image with a characteristic of a wall of a body lumen([0058] the target may be a blood vessel, and the device 100 is in the form a catheter to be inserted into the blood vessel; [0089] the optical imaging would provide an image of a body lumen when inserted into a body lumen, or a surface of a target would also be a wall), and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
Regarding claim 5, modified Tarumoto teaches the device of claim 4, but fails to explicitly disclose the characteristic of a wall of a body lumen, and the characteristic external to the wall of the body lumen.
In the same intraluminal field of endeavor, Abraham further teaches the characteristic of a wall of a body lumen([0058] the target may be a blood vessel, and the device 100 is in the form a catheter to be inserted into the blood vessel; [0089] the optical imaging would provide an image of a body lumen when inserted into a body lumen, or a surface of a target would also be a wall; this image would include the characteristic of the wall of the body lumen), and the characteristic external to the wall of the body lumen([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
However, the combination of references are still silent regarding the generation of an image based on the first and second images.
In the same ultrasound imaging field of endeavor, Chen teaches the generation of the image based on the first and second images based on the characteristics of the images ([0031] the computer generates an image based on image data from the ultrasound, optical coherence, and acoustic radiation force).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the different images generation by the optical and ultrasound sensor of modified Tarumoto with the process of generation an image based on the data from the different imaging modalities of Chen, as this would combine the advantages of high spatial resolution of OCT and the broad imaging depth of ultrasound (see Chen [0018]). One of ordinary skill in the art would understand that the image combination process of Chen would apply to the first and second images of modified Tarumoto, and that the first and second images contain the characteristic of the wall of the body lumen and the characteristic external to the wall of the body lumen. Therefore, the image based on the first and second images would include the characteristic of the wall of the body lumen and the characteristic external to the wall of the body lumen.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Chen, and Abraham as applied to claim 5 above, and in further view Fahey et al., (US20180344411A1)
Regarding claim 6, modified Tarumoto teaches the device of claim 5, fails to explicitly disclose wherein the articulation joint is configured to contact the wall of the body lumen with the second transducer to facilitate generation of the second image.
In the same intraluminal field of endeavor, Fahey teaches wherein the articulation joint is configured to contact the wall of the body lumen with the second transducer to facilitate generation of the second image (fig. 28A transducer 2802 is contacting the wall of the body lumen, which allow for maximum ultrasonic energy transmission. In this way the transmitted ultrasound signal can be oriented to provide an increased accuracy related to Doppler measurements being made for vessels that run parallel or closely parallel to the tissue surface [0187]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the use of the articulation joint of Fahey, as this would provide an increase of accuracy to Doppler related measurements (see Fahey [0187]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto as modified by Tanaka, Chen, and Fahey as applied to claim 6 above, and further in view of Tearney et al., (US20160029894A1).
Regarding claim 7, modified Tarumoto teaches the device of claim 6, but is silent regarding an energy source generating a pulse of energy to excite tissue external to the wall of the body lumen, and the second transducer is a sensor configured to detect sound waves generated by optically-excited targets and to generate an image based on the detected sound waves.
In the same acoustic field of endeavor, Tearney teaches an energy source generating a pulse of energy to excite tissue external to the wall of the body lumen ([0008] there is a light guide that forwards the radiation to the pulmonary artery and aorta through the wall of an esophagus), and the second transducer is a sensor configured to detect sound waves generated by optically-excited targets and to generate an image based on the detected sound waves (fig. 2 after the illumination of light 210, acoustic waves 212 and 216 are generated, which can be detected by acoustic transducer 234, and real-time sonographic images can be obtained [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to have the energy source and transducer of Tearney, as this would more accurately characterize an object within a tissue (see Tearney [0006]).
Claims 8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Maguire et al., (US20030176816A1), Chen, and Abraham.
Regarding claim 8, Tarumoto teaches a medical device (fig. 1 is of a endoscope bending [0024]) comprising:
a flexible elongate member having a proximal portion and a distal portion (see annotated fig. 1 the endoscope comprise the ultrasonic scanning unit 3a, optical observation unit 3b, and bending portion 2a [0008]);
a first transducer having a first focal region disposed along the distal portion of the flexible elongate member and the first transducer configured to generate a first image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]);
a second transducer along the distal portion of the flexible elongate member and the second transducer configured to generate a second image (fig. 4 ultrasonic probe 11 [0008]); and
an articulation joint disposed along the distal portion of the flexible elongate member between the first transducer and the second transducer (fig. 5 universal joint 20 is between the ultrasonic unit 3a and optical observation unit 3b and allows the scanning unit 3a to be rotatable [0011]-[0012] ), the articulation joint configured to position the second transducer to facilitate generation of the image (fig. 6 the universal joint 20 allows the ultrasonic probe to reposition).
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However Tarumoto is silent regarding the second transducer a portion of the first focal region of the first transducer.
In the same endoscope field of endeavor, Tanaka teaches the second transducer a portion of the first focal region of the first transducer (fig. 3 the endoscopic image pickup portion 13 has an observation field W1 and includes the ultrasonic transducers 19 col. 5 lines 46-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of ultrasonic transducers within the focal region of an optical sensor as taught by Tanaka to the base endoscopic device of Tarumoto, as both inventions relate to ultrasonic endoscopes, and would yield the predictable result of an ultrasonic endoscope with an articulation joint that can move the ultrasonic transducers into the focal region of the optical sensor to one of ordinary skill. One of ordinary skill would be able to perform such an application, and the results of Tarumoto having an ultrasonic endoscope that can have its transducers be in the focal region of an optical sensor are reasonably predictable. This would improve targeting accuracy and reduce the likelihood of unintended tissue contact or improper instrument positioning. One of ordinary skill would understand this combination would allow the universal joint of Tarumoto to be capable of moving the ultrasonic transducers into the focal region of the optical sensor and thus read upon the claim limitation.
However, the combination of references are still silent regarding the generation of an image based on the first and second images.
In the same ultrasound imaging field of endeavor, Chen teaches the generation of an image based on the first and second images ([0031] the computer generates an image based on image data from the ultrasound, optical coherence, and acoustic radiation force).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging system of Tarumoto with the transducers and the combining of images of Chen, as this would combine the advantages of high spatial resolution of OCT and the broad imaging depth of ultrasound (see Chen [0024]).
However the combination of references are silent wherein the first transducer configured to generate the first image with a characteristic of a wall of a body lumen, and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen.
However in the same intraluminal field of endeavor, Abraham teaches the first transducer configured to generate the first image with a characteristic of a wall of a body lumen([0058] the target may be a blood vessel, and the device 100 is in the form a catheter to be inserted into the blood vessel; [0089] the optical imaging would provide an image of a body lumen when inserted into a body lumen, or a surface of a target would also be a wall), and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
However, Tarumoto fails to disclose a first balloon and a second balloon disposed around the distal portion of the flexible elongate member, the first and second balloons configured to position the second transducer within the body lumen, wherein the first and second transducers are disposed between the first balloon and the second balloon along the distal portion of the flexible elongate member.
In the same ultrasound field of endeavor, Maguire teaches a first balloon (fig. 5F expandable member 526 [0205]; [0028] expandable member includes a balloon) and a second balloon (fig. 5F expandable member 528 [0205]; [0028] expandable member includes a balloon) disposed around the distal portion of the flexible elongate member (fig. 5A the ultrasonic sensing element 516 is on the distal end of the catheter [0201]; therefore the system of fig. 5F would also be on the distal end), the first and second balloons configured to position the second transducer within the body lumen (fig. 5F transducer 518 is between expandable member 526 and 528 [0205]), wherein the first and second transducers are disposed between the first balloon and the second balloon along the distal portion of the flexible elongate member (fig. 5F transducer 518 is between expandable member 526 and 528 [0205]; fig. 5A the ultrasonic sensing element 516 is on the distal end of the catheter [0201]; therefore the system of fig. 5F would also be on the distal end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Tarumoto with the balloons of Maguire, as this would allow users to position the sensors in the desired location without affecting the shape of the expandable member and/or impede further adjustment of the expandable member (see Maguire [0042]).
Regarding claim 10, modified Tarumoto teaches the device of claim 10, wherein Tarumoto further teaches the first transducer comprising an optical sensor, the first image comprising an optical image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]), the second transducer comprising an ultrasonic transducer and the second image comprising an ultrasound image (fig. 4 ultrasonic probe 11 [0008]).
Regarding claim 12, modified Tarumoto teaches the device of claim 8, but is silent regarding the characteristic of a wall of a body lumen, and the characteristic external to the wall of the body lumen.
However in the same intraluminal field of endeavor, Abraham teaches the characteristic of a wall of a body lumen([0058] the target may be a blood vessel, and the device 100 is in the form a catheter to be inserted into the blood vessel; [0089] the optical imaging would provide an image of a body lumen when inserted into a body lumen, or a surface of a target would also be a wall; this image would include the characteristic of the wall of the body lumen), and the characteristic external to the wall of the body lumen([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
However, the combination of references are still silent regarding the generation of an image based on the first and second images.
In the same ultrasound imaging field of endeavor, Chen teaches the generation of the image based on the first and second images on the characteristics of the images ([0031] the computer generates an image based on image data from the ultrasound, optical coherence, and acoustic radiation force).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the different images generation by the optical and ultrasound sensor of modified Tarumoto with the process of generation an image based on the data from the different imaging modalities of Chen, as this would combine the advantages of high spatial resolution of OCT and the broad imaging depth of ultrasound (see Chen [0018]). One of ordinary skill in the art would understand that the image combination process of Chen would apply to the first and second images of modified Tarumoto, and that the first and second images contain the characteristic of the wall of the body lumen and the characteristic external to the wall of the body lumen. Therefore, the image created by the first and second images would include the characteristic of the wall of the body lumen and the characteristic external to the wall of the body lumen.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Maguire, Chen, and Abraham as applied to claim 8 above, and further in view of Nakatsuji (US20190282210A1) and Wong et al., (US 20190298451 A1).
Regarding claim 11, modified Tarumoto teaches the device of claim 8, but fails to explicitly disclose wherein the characteristic of the wall of the body lumen comprises a papilla of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct.
In the same ultrasound endoscope field of endeavor, Nakatsuji teaches wherein the characteristic of the wall of the body lumen comprises of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct ([0029] the endoscope is inserted into the duodenum (which includes the papilla) to capture the bile duct).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to place the device in the duodenum as taught by Nakatsuji, as this would make it possible to represent tissue characteristics in multiple regions of interest clearly and distinctively (see Nakatsuji [0169]).
While Nakatsuji does disclose the device imaging in the duodenum, they are silent regarding the papilla.
In the same ultrasound endoscope field of endeavor, Wong teaches imaging the papilla ([0056] the papilla of Vater can be identified in endoscopic camera images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to also image the papilla as taught by Wong, as this would allow for the physician to avoid sensitive anatomy during treatment (see Wong [0056])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Maguire, Chen, and Abraham as applied to claim 8 above, and further in view of Brown (US20140180079A1).
Regarding claim 9, modified Tarumoto teaches the device of claim 8, but is silent regarding teaches the second image comprising the characteristic external to the wall of the body lumen.
However, in the same intraluminal field of endeavor, Abraham teaches the second image comprising the characteristic external to the wall of the body lumen ([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
However the combination of references fail to explicitly disclose a fluid channel with an exit disposed between the first balloon and the second balloon to fill a region of the body lumen between the first and second balloons with a fluid to facilitate generation of the second image comprising the characteristic external to the wall of the body lumen.
In the same ultrasound field of endeavor, Brown teaches a fluid channel with an exit (fig. 1 guarded zone lumen 120 is used to transfer liquid into the guarded zone 115, which would require an exit port [0027]) disposed between the first balloon and the second balloon (fig. 1 the exit port for the guarded zone lumen 120 is between first and second balloon assemblies 110 and 112 [0027]) to fill a region of the body lumen between the first and second balloons with a fluid (fig. 1 the guarded zone 115 is filled with imaging fluid that replaces the blood) to facilitate generation of the second image (fig. 1 imaging component 132 can be an ultrasound device [0029]; [0028] the imaging fluid used is a solution that permits high quality imaging or free of particles or other distortion-causing components for modalities) comprising the characteristic external to the wall of the body lumen ([0042] the fluid is used with ultrasound, which can penetrate the wall of the body lumen and thus image characteristics external to the wall of the body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the fluid of Brown, as this would provide clearer images (see Brown [0042])
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Maguire, Chen, and Abraham as applied to claim 8 above, and in further view Fahey et al., (US20180344411A1).
Regarding claim 13, modified Tarumoto teaches the device of claim 8, wherein Tarumoto further teaches the articulation joint (fig. 5 joint 20) facilitates generation of the second image (fig. 6 the joint 20 allows for the probe to reposition), but fails to explicitly disclose wherein the articulation joint is configured to contact the wall of the body lumen with the second transducer to facilitate generation of the second image.
In the same intraluminal field of endeavor, Fahey teaches wherein the articulation joint is configured to contact the wall of the body lumen with the second transducer to facilitate generation of the second image (fig. 28A transducer 2802 is contacting the wall of the body lumen because of joint 2803, which allows for maximum ultrasonic energy transmission. In this way the transmitted ultrasound signal can be oriented to provide an increased accuracy related to Doppler measurements being made for vessels that run parallel or closely parallel to the tissue surface [0187]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the use of the articulation joint of Fahey, as this would provide an increase of accuracy to Doppler related measurements (see Fahey [0187]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Maguire, Chen, and Abraham as applied to claim 8 above, and further in view of Tearney.
Regarding claim 14, modified Tarumoto teaches the device of claim 8, but is silent regarding an energy source generating a pulse of energy to excite tissue external to the wall of the body lumen, and the second transducer is a sensor configured to detect sound waves generated by optically-excited targets and to generate an image based on the detected sound waves.
In the same acoustic field of endeavor, Tearney teaches an energy source generating a pulse of energy to excite tissue external to the wall of the body lumen ([0008] there is a light guide that forwards the radiation to the pulmonary artery and aorta through the wall of an esophagus), and the second transducer is a sensor configured to detect sound waves generated by optically-excited targets and to generate an image based on the detected sound waves (fig. 2 after the illumination of light 210, acoustic waves 212 and 216 are generated, which can be detected by acoustic transducer 234, and real-time sonographic images can be obtained [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to have the energy source and transducer of Tearney, as this would more accurately characterize an object within a tissue (see Tearney [0006]).
Claims 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Chen, and Abraham.
Regarding claim 15, Tarumoto teaches of a medical device (fig. 1 is of a endoscope bending [0024]) comprising:
a flexible elongate member having a proximal portion and a distal portion (see annotated fig. 1 the endoscope comprise the ultrasonic scanning unit 3a, optical observation unit 3b, and bending portion 2a [0008]);
a first transducer having a first focal region disposed along the distal portion of the flexible elongate member and the first transducer configured to generate a first image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]);
a second transducer along the distal portion of the flexible elongate member and the second transducer configured to generate a second image (fig. 4 ultrasonic probe 11 [0008]); and
an articulation joint disposed along the distal portion of the flexible elongate member between the first transducer and the second transducer (fig. 5 universal joint 20 is between the ultrasonic unit 3a and optical observation unit 3b and allows the scanning unit 3a to be rotatable [0011]-[0012] ), the articulation joint configured to position the second transducer to facilitate generation of the image (fig. 6 the universal joint 20 allows the ultrasonic probe to reposition).
However, Tarumoto is silent regarding a processor; and memory comprising that when executed by the processor cause the processor to create a combined image comprising an image based on the first and second images.
In the same ultrasound imaging field of endeavor, Chen teaches a processor ([0024] computer); and memory ([0042] memory) comprising that when executed by the processor cause the processor to create a combined image comprising an image based on the first and second images ([0031] the computer generates an image based on image data from the ultrasound, optical coherence, and acoustic radiation force).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging system of Tarumoto with the transducers and the combining of images of Chen, as this would combine the advantages of high spatial resolution of OCT and the broad imaging depth of ultrasound (see Chen [0024]).
However the combination of references are silent wherein the first transducer configured to generate the first image with a characteristic of a wall of a body lumen, and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen.
However in the same intraluminal field of endeavor, Abraham teaches the first transducer configured to generate the first image with a characteristic of a wall of a body lumen([0058] the target may be a blood vessel, and the device 100 is in the form a catheter to be inserted into the blood vessel; [0089] the optical imaging would provide an image of a body lumen when inserted into a body lumen, or a surface of a target would also be a wall), and the second transducer configured to generate the second image comprising a characteristic external to the wall of the body lumen([0058] the target may be a blood vessel, and the device is in the form of a catheter sheath an inserted in the blood vessel [0089] the ultrasound imaging can penetrate the target, thereby including characteristics beyond a wall of a body lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto with the dual imaging mode of Abraham, as this would allow for an operator to have more information regarding the target site and consequently the treatment to be applied (see Abraham [0089]).
Regarding claim 19, modified Tarumoto teaches the device of claim 15, wherein Tarumoto further teaches the first transducer comprising an optical sensor, the first image comprising an optical image (fig. 4 the optical observation unit includes an image sensor in the window 12 [0010]), the second transducer comprising an ultrasonic transducer and the second image comprising an ultrasound image (fig. 4 ultrasonic probe 11 [0008]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto as modified by Tanaka, Chen, and Abraham as applied to claim 15 above, and further in view of Rauniyar et al., (US20180139392A1).
Regarding claim 16, modified Tarumoto teaches the device of claim 15, but fails to explicitly disclose wherein the memory comprises instructions to determine a trajectory visualization based on the first and second images.
In the same imaging field of endeavor, Rauniyar teaches wherein the memory comprises instructions to determine a trajectory visualization based on the first and second images([0012] “modifying the body information model by combining the first images with the second images at the target location; outputting a portion of the body information model as a navigation image; identifying a path through the body in the navigation image; identifying a location of the navigation component in the navigation image; and/or guiding the navigation component along the path in the navigation image.”).
It would have been obvious to one of ordinary skill in the art at the time to modify the apparatus of modified Tarumoto with the path and navigation images of Rauniyar as this would help guide medical devices through a greater range of body paths and reduce the risks associated with using these devices in those ranges (See Rauniyar [0004]).
Regarding claim 17, modified Tarumoto teaches the device of claim 16, but fails to explicitly disclose wherein the memory comprises instructions to generate an indication of the trajectory visualization in the combined image.
However in the same lumen imaging field of endeavor, Rauniyar teaches wherein the memory comprises instructions to generate an indication of the trajectory visualization in the combined image ([0012] “modifying the body information model by combining the first images with the second images at the target location; outputting a portion of the body information model as a navigation image; identifying a path through the body in the navigation image; identifying a location of the navigation component in the navigation image; and/or guiding the navigation component along the path in the navigation image.”).
It would have been obvious to one of ordinary skill in the art at the time to modify the apparatus of modified Tarumoto with the path and navigation component in the combine image of Rauniyar, as this would help guide medical devices through a greater range of body paths and reduce the risks associated with using these devices in those ranges (See Rauniyar [0004]).
Regarding claim 18, modified Tarumoto teaches the device of claim 16, but is silent regarding a light source disposed along the distal portion of the flexible elongate member, wherein the memory further comprises instructions to generate an indication of the trajectory visualization with the light source inside the body lumen.
However in the same intraluminal field of endeavor, Abraham teaches a light source disposed along the distal portion of the flexible elongate member (see annotated fig. 1a, the optic bundle 602 (see fig. 6) would be disposed along the distal portion of the catheter [0089]) comprising generating an indication of the trajectory visualization with a light source (#602) inside the body lumen (fig. 6 Abstract since the light source lights the forward path of the advancing catheter, it would give a visualization on the trajectory (forward)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application combine device of modified Tarumoto with the forward facing light of Abraham, as both inventions relate to imaging intraluminal field and would yield the predictable result of a intraluminal device with a forward facing optical light to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the result of the device of modified Tarumoto having a forward facing light source are reasonably predictable.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Chen, and Abraham as applied to claim 15 above, and further in view of Nakatsuji and Wong.
Regarding claim 20, modified Tarumoto teaches the device of claim 15, but fails to explicitly disclose wherein the characteristic of the wall of the body lumen comprises a papilla of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct.
In the same ultrasound endoscope field of endeavor, Nakatsuji teaches wherein the characteristic of the wall of the body lumen comprises of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct ([0029] the endoscope is inserted into the duodenum (which includes the papilla) to capture the bile duct).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to place the device in the duodenum as taught by Nakatsuji, as this would make it possible to represent tissue characteristics in multiple regions of interest clearly and distinctively (see Nakatsuji [0169]).
While Nakatsuji does disclose the device imaging in the duodenum, they are silent regarding the papilla.
In the same ultrasound endoscope field of endeavor, Wong teaches imaging the papilla ([0056] the papilla of Vater can be identified in endoscopic camera images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to also image the papilla as taught by Wong, as this would allow for the physician to avoid sensitive anatomy during treatment (see Wong [0056]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tarumoto in view of Tanaka, Chen, and Abraham as applied to claim 4 above, and further in view of Nakatsuji and Wong.
Regarding claim 21, modified Tarumoto teaches the device of claim 4, but fails to explicitly disclose wherein the characteristic of the wall of the body lumen comprises a papilla of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct.
In the same ultrasound endoscope field of endeavor, Nakatsuji teaches wherein the characteristic of the wall of the body lumen comprises of a duodenal wall and wherein the characteristic external to the wall of the body lumen comprises a bile duct and/or a pancreatic duct ([0029] the endoscope is inserted into the duodenum (which includes the papilla) to capture the bile duct).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to place the device in the duodenum as taught by Nakatsuji, as this would make it possible to represent tissue characteristics in multiple regions of interest clearly and distinctively (see Nakatsuji [0169]).
While Nakatsuji does disclose the device imaging in the duodenum, they are silent regarding the papilla.
In the same ultrasound endoscope field of endeavor, Wong teaches imaging the papilla ([0056] the papilla of Vater can be identified in endoscopic camera images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Tarumoto to also image the papilla as taught by Wong, as this would allow for the physician to avoid sensitive anatomy during treatment (see Wong [0056]).
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Tarumoto, Tanaka, and Chen have now been used to teach the claim.
The remaining claims are rejected for substantially the same reasons as above.
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.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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